NOVEMBER 20, 2020_AuSTRALIA (TGA)
Updates to electronic application for a Conformity Assessment Certificate
The electronic application form for a Conformity Assessment Certificate that is accessible via the TGA Business Services (TBS) portal has been updated.
The application is now for a:
The electronic application form for a Conformity Assessment Certificate that is accessible via the TGA Business Services (TBS) portal has been updated.
The application is now for a:
- Initial application
- Substantial change notification and application
- Recertification of an expiring certificate
NOVEMBER 5, 2020_UK (MHRA)
Guidance Regulating medical devices from 1 January 2021
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
This guidance provides information on how the UK system will operate, including for:
For Northern Ireland, different rules will apply to those in Great Britain after the end of the transition period.
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
This guidance provides information on how the UK system will operate, including for:
- Getting your device certified
- Conformity marking your device
- Registering your device with the MHRA
For Northern Ireland, different rules will apply to those in Great Britain after the end of the transition period.
OCTOBER 30, 2020_TAIWAN (TFDA)
Taiwan regulator releases draft guidances for medical device vigilance reporting
The first guidance, Medical Device Safety Surveillance Management Measures (links in Mandarin), defines the requirements surrounding submission to the TFDA of Periodic Safety Update Reports (PSURs). These reports have generally been required for the first three years that a new device is on market in Taiwan.
A second guidance, Measures for Notification of Serious Adverse Events of Medical Devices, outlines updated adverse event reporting requirements and procedures, complete with corresponding timelines.
Interested parties have 60 days from the publication of the announcements to submit feedback or suggest amendments to the draft guidance documents. Contact information for the proper individuals within the TFDA is provided in each announcement.
The first guidance, Medical Device Safety Surveillance Management Measures (links in Mandarin), defines the requirements surrounding submission to the TFDA of Periodic Safety Update Reports (PSURs). These reports have generally been required for the first three years that a new device is on market in Taiwan.
A second guidance, Measures for Notification of Serious Adverse Events of Medical Devices, outlines updated adverse event reporting requirements and procedures, complete with corresponding timelines.
Interested parties have 60 days from the publication of the announcements to submit feedback or suggest amendments to the draft guidance documents. Contact information for the proper individuals within the TFDA is provided in each announcement.
OCTOBER 19, 2020_europe (EUROPEAN COMMISSION)
Actor registration module
The European Commission will make available the Actor registration module to Member States and economic operators from 1 December 2020.
It is the first of six EUDAMED modules.
The European Commission will make available the Actor registration module to Member States and economic operators from 1 December 2020.
It is the first of six EUDAMED modules.
- Access to EUDAMED database – active from 1 December
- EUDAMED webpage – active from 1 December
OCTOBER 15, 2020_USA (FDA)
Draft guidance_Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
Submit Comments by 12/14/2020
Submit Comments by 12/14/2020
OCTOBER 14, 2020_FRANCE (HAS)
Mise à jour des guides HAS_Intelligence artificielle
Avec l'arrivée de dispositifs médicaux dotés d'intelligence artificielle, la HAS met ajout ses guides de dépôt de dossiers pour accompagner les entreprises dans la constitution de leur demande d'accès au remboursement ou de forfait innovation.
Demande LPPR: https://www.has-sante.fr/upload/docs/application/pdf/2016-01/guide_fabricant_2016_01_11_cnedimts_vd.pdf#page=51
Matrice du dossier: https://www.has-sante.fr/plugins/ModuleXitiKLEE/types/FileDocument/doXiti.jsp?id=p_3151810
Forfait innovation: https://www.has-sante.fr/upload/docs/application/pdf/2020-10/fi_guide_de_depot__2020_10_01.pdf#page=41
Avec l'arrivée de dispositifs médicaux dotés d'intelligence artificielle, la HAS met ajout ses guides de dépôt de dossiers pour accompagner les entreprises dans la constitution de leur demande d'accès au remboursement ou de forfait innovation.
Demande LPPR: https://www.has-sante.fr/upload/docs/application/pdf/2016-01/guide_fabricant_2016_01_11_cnedimts_vd.pdf#page=51
Matrice du dossier: https://www.has-sante.fr/plugins/ModuleXitiKLEE/types/FileDocument/doXiti.jsp?id=p_3151810
Forfait innovation: https://www.has-sante.fr/upload/docs/application/pdf/2020-10/fi_guide_de_depot__2020_10_01.pdf#page=41
OCTOBER 13, 2020_INTERNATIONAL (IMDRF)
IMDRF consultation "Post-Market Clinical Follow-Up Studies"
A Proposed Document on Post-Market Clinical Follow-up Studies has been released by the International Medical Device Regulators Forum (IMDRF) Medical Devices Clinical Evaluation Working Group.
This consultation closed on Friday, 11 December 2020.
This document is intended to provide guidance on the design, implementation and appropriate use of PMCF studies.
A Proposed Document on Post-Market Clinical Follow-up Studies has been released by the International Medical Device Regulators Forum (IMDRF) Medical Devices Clinical Evaluation Working Group.
This consultation closed on Friday, 11 December 2020.
This document is intended to provide guidance on the design, implementation and appropriate use of PMCF studies.
OCTOBER 13, 2020_AUSTRALIA (TGA)
New compliance dashboard for post-market medical device reviews
From 19 October 2020, the process by which the Therapeutic Good Administration (TGA) engages with sponsors will change. A new Post Market Review Compliance Dashboard has been developed to replace the existing process of responding to a post-market review and sending associated documentation by email to the TGA.
From 19 October 2020, the process by which the Therapeutic Good Administration (TGA) engages with sponsors will change. A new Post Market Review Compliance Dashboard has been developed to replace the existing process of responding to a post-market review and sending associated documentation by email to the TGA.
- Sponsors will be able to directly respond to post-market reviews in the new dashboard that can be accessed through TBS.
- The new dashboard provides an efficient and secure way of responding to post-market reviews and storing the information in a central location. This will also make it easier to access reviews (active and closed) and remove the need to resend information to different teams at the TGA as they will have access to this information in the dashboard.
- The dashboard has the capability to upload relevant files up to 15GB (per file) size and removes the need to send files via the Cloud, email or sending USBs.
The TGA's approach to delays in medical device conformity assessment recertification
Due to COVID-19 pandemic and delays in EU MDR implementation
The Therapeutic Goods Administration (TGA) is issuing this guidance to inform sponsors (and, where relevant, manufacturers) about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due to COVID-19 and the limitations on the current number of notified bodies designated under the European Medical Devices Regulation (MDR).
This guidance applies to both overseas and Australian conformity assessment documents. However, where there is a need to distinguish between the two, we use more specific terms.
Due to COVID-19 pandemic and delays in EU MDR implementation
The Therapeutic Goods Administration (TGA) is issuing this guidance to inform sponsors (and, where relevant, manufacturers) about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due to COVID-19 and the limitations on the current number of notified bodies designated under the European Medical Devices Regulation (MDR).
This guidance applies to both overseas and Australian conformity assessment documents. However, where there is a need to distinguish between the two, we use more specific terms.
OCTOBER 1, 2020_AUSTRALIA (TGA)
Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices
From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian Register of Therapeutic Goods (ARTG) will change. The changes will not at this stage apply to Class 1 IVD medical devices, Class I Export Only and Class I IVD Export Only devices.
From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian Register of Therapeutic Goods (ARTG) will change. The changes will not at this stage apply to Class 1 IVD medical devices, Class I Export Only and Class I IVD Export Only devices.
- Applicants will need to provide a manufacturer's Declaration of Conformity with their application to include the device in the ARTG , rather than simply hold such a document at the time they apply for inclusion.
- The manufacturer's Declaration of Conformity form for Class I non-sterile, non-measuring devices has been revised to be more user-friendly.
- The TGA will assess the applications for compliance with the legal requirements for Class I medical devices to be included in the ARTG.
- After conducting the assessment:
- If the TGA is not satisfied that the product meets all the requirements for inclusion in the ARTG, the TGA select the application for non-mandatory audit.
- if the TGA is satisfied that the product meets all the requirements for inclusion in the ARTG , the TGA will include the device in the ARTG within four (4) business days of receiving the application.
- The TGA may conduct non-mandatory audits of Class I applications where (for example) there are concerns regarding a kind of device or it appears from the application that:
- The device is not a medical device ;
- The device is incorrectly classified;
- The device does not comply with the essential principles ;
- The device has not had the appropriate conformity assessment procedures applied to it; or
- The information supplied in or with the application is not complete or correct.
- You may wish to check if your product is a medical device using the SME Assist tool .
- All Class I devices included in the ARTG will continue to be subject to post-market reviews, in accordance with the existing process.
SEPTEMBER 25, 2020_AUSTRALIA (TGA)
Is my product a medical device?
This tool will help you determine if your product is a medical device and should be included in the Australia Register of Therapeutic Goods (ARTG). For products already included in the ARTG, you can use this tool to help you determine if your product is a medical device or another type of good and if you should cancel your ARTG entry.
This tool will help you determine if your product is a medical device and should be included in the Australia Register of Therapeutic Goods (ARTG). For products already included in the ARTG, you can use this tool to help you determine if your product is a medical device or another type of good and if you should cancel your ARTG entry.
SEPTEMBER 21, 2020_BRAZIL (ANVISA)
ANVISA eliminates Cadastro pathway for Class II medical devices
On September 18, Brazil’s National Health Surveillance Agency (ANVISA), published RDC No. 423/2020 (link in Portuguese), a new Resolution of the Collegiate Board of Directors (RDC) declaring the elimination of the Cadastro pathway for the registration of Class II medical devices and IVDs.
According to the Resolution, Class I and II devices henceforth only require a Notification (Notificação) and are not subject to approval by ANVISA prior to commercialization in Brazil.
Under the Cadastro system, manufacturers of Class II as well as some Class I devices were required to provide comprehensive technical dossiers, labeling materials and proposed indications for use (IFU) documents to their Brazilian Registration Holder (BRH) in-country representatives. Now, manufacturers will not be required to submit a technical dossier, but they are expected to have such documentation available upon request in the event of audits by ANVISA. The Notificação pathway was put into place in 2019 and initially replaced the Cadastro for low-risk Class I devices only.
On September 18, Brazil’s National Health Surveillance Agency (ANVISA), published RDC No. 423/2020 (link in Portuguese), a new Resolution of the Collegiate Board of Directors (RDC) declaring the elimination of the Cadastro pathway for the registration of Class II medical devices and IVDs.
According to the Resolution, Class I and II devices henceforth only require a Notification (Notificação) and are not subject to approval by ANVISA prior to commercialization in Brazil.
Under the Cadastro system, manufacturers of Class II as well as some Class I devices were required to provide comprehensive technical dossiers, labeling materials and proposed indications for use (IFU) documents to their Brazilian Registration Holder (BRH) in-country representatives. Now, manufacturers will not be required to submit a technical dossier, but they are expected to have such documentation available upon request in the event of audits by ANVISA. The Notificação pathway was put into place in 2019 and initially replaced the Cadastro for low-risk Class I devices only.
SEPTEMBER 17, 2020_UK (MHRA)
Safety-critical alerts are changing at the MHRA
The MHRA will now issue all safety-critical alerts for medicines and medical devices that require action as National Patient Safety Alerts
The MHRA will now issue all safety-critical alerts for medicines and medical devices that require action as National Patient Safety Alerts
SEPTEMBER 4, 2020_USA (FDA)
Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
This document discusses the following topics:
This document discusses the following topics:
- use of risk assessments for biocompatibility evaluations for a proposed medical device;
- use of ISO 10993-1 and the FDA-modified matrix (Attachment A) to determine the relevant biocompatibility endpoints for an evaluation;
- general biocompatibility testing considerations, including test article preparation;
- specific considerations for the following testing: cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and degradation assessments;
- chemical assessment recommendations; and
- considerations for labeling devices as “-free.”
- Attachment B: Device Master Files (MAFs) for Biocompatibility Evaluations, which includes information that we recommend including in an MAF;
- Attachment C: Summary Biocompatibility Documentation, which includes an example table that we recommend using to summarize the biocompatibility information used to support a submission;
- Attachment D: Biocompatibility Evaluation Flow Chart, which illustrates how to proceed with a biocompatibility evaluation;
- Attachment E: Content of a Biocompatibility Test Report, which includes the recommended contents of a test report;
- Attachment F: Component and Device Documentation Examples, which outlines example documentation language that we recommend using when comparing the composition of a test article to the composition of a finished medical device or in comparing the composition of a previously legally US-marketed device to the composition of a current device; and
- Attachment G: Glossary, which includes terms and definitions used in this guidance.
SEPTEMBER 4, 2020_FRANCE (GMED)
Free Guide_GMED "MD Clinical Evaluation - Summary of Safety and Clinical Performance (SSCP) - Regulation (EU) 2017/745"
This guide is available in French and English.
FR Version: http://www.lne-gmed.com/en/guides/guide-application-request-clinical-evaluation-DM-regulation-2017-745.asp
EN Version: http://www.gmed.fr/pages/guides/recevoir-guide-evaluation-clinique-DM-reg-2017-45.asp?IdDoc=24
This guide is available in French and English.
FR Version: http://www.lne-gmed.com/en/guides/guide-application-request-clinical-evaluation-DM-regulation-2017-745.asp
EN Version: http://www.gmed.fr/pages/guides/recevoir-guide-evaluation-clinique-DM-reg-2017-45.asp?IdDoc=24
September 1, 2020_UK (MHRA)
Guidance_Regulating medical devices from 1 January 2021
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
This guidance provides information on how the UK system will operate, including for:
- Overview
- The legislation
- The role of the MHRA
- Requirements for those manufacturing and supplying devices in the UK
- UKCA mark and Conformity Assessment Bodies
- CE marking and Notified Bodies
- Labelling requirements
- Post-market surveillance and vigilance
- Regulation of medical devices in Northern Ireland
- Placing a medical device on the EU market
- Contact
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
This guidance provides information on how the UK system will operate, including for:
- Getting your device certified
- Conformity marking your device
- Registering your device with the MHRA
- Overview
- The legislation
- The role of the MHRA
- Requirements for those manufacturing and supplying devices in the UK
- UKCA mark and Conformity Assessment Bodies
- CE marking and Notified Bodies
- Labelling requirements
- Post-market surveillance and vigilance
- Regulation of medical devices in Northern Ireland
- Placing a medical device on the EU market
- Contact
AUGUST 29, 2020_EUROPE (EUROPEAN COMMISSION)
Republished EC factsheet (April 24th, 2020 release)
Each factsheet includes FAQs
- authorised representatives / importers / distributors
- medical device competent authorities in third countries
- healthcare professionals and healthcare institutions
- manufacturers of in vitro diagnostic medical devices
- medical device manufacturers
- medical device procurement ecosystem
- step-by-step guide for manufacturers of in vitro diagnostic medical devices
- step-by-step guide for medical device manufacturers
Each factsheet includes FAQs
- authorised representatives / importers / distributors
- medical device competent authorities in third countries
- healthcare professionals and healthcare institutions
- manufacturers of in vitro diagnostic medical devices
- medical device manufacturers
- medical device procurement ecosystem
- step-by-step guide for manufacturers of in vitro diagnostic medical devices
- step-by-step guide for medical device manufacturers
AUGUST 25, 2020_AUSTRALIA (TGA)
Update to medical device definitions and requirements for system or procedure packs
On 25 August 2020, two changes will commence:
On 25 August 2020, two changes will commence:
- new medical device definition and a number of other related definitions in the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations); and
- minor amendments to the requirements for system or procedure packs in the Regulations.
AUGUST 3, 2020_EUROPE (BSI)
White paper: Medical device clinical investigations – What’s new under the MDR?
The conduct of a clinical investigation is one of the most time consuming and resource intensive activities that a medical device manufacturer can face. This paper discusses important new requirements for pre-market and post-market clinical investigations under the European MDR.
The conduct of a clinical investigation is one of the most time consuming and resource intensive activities that a medical device manufacturer can face. This paper discusses important new requirements for pre-market and post-market clinical investigations under the European MDR.
JULY 31, 2020_EUROPE (EUROPHARMAT)
Guide sur l'application du règlement (UE) 2017/745 relatif aux dispositifs médicaux à destination des établissements de santé
Le SNITEM & EURO-PHARMAT ont mis à jour le guide sur l'impact du règlement européen pour les établissements de santé, publié initialement en octobre 2019.
Cette nouvelle version, juillet 2020 - prend en compte, en particulier les nouvelles échéances calendaires.
Le SNITEM & EURO-PHARMAT ont mis à jour le guide sur l'impact du règlement européen pour les établissements de santé, publié initialement en octobre 2019.
Cette nouvelle version, juillet 2020 - prend en compte, en particulier les nouvelles échéances calendaires.
JULY 31, 2020_INTERNATIONAL (ISO)
Publication of the ISO 14155:2020_Clinical investigation of medical devices for human subjects — Good clinical practice
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
JULY 31, 2020_INTERNATIONAL (ISO)
Publication of the ISO/TR 20416:2020Medical devices — Post-market surveillance for manufacturers
This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities.
This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities.
JULY 29, 2020_FRANCE (HAS)
Choices in Methods for Economic Evaluation
This guide presents the principles and methods used by HAS (the French National Health Authority) to carry out its mission of providing economic evaluations of health interventions. In this specific context, economic evaluation allows health interventions to be compared on the basis of their health effects and costs.
The 2020 version has been enriched by the experience of the past ten years.
This guide presents the principles and methods used by HAS (the French National Health Authority) to carry out its mission of providing economic evaluations of health interventions. In this specific context, economic evaluation allows health interventions to be compared on the basis of their health effects and costs.
The 2020 version has been enriched by the experience of the past ten years.
JULY 17, 2020_EUROPE (EUROPEAN COMMISSION)
MDCG 2020-13 Clinical evaluation assessment report template
A harmonised CEAR template provides a standardised method for documenting the notified body’s assessment of the manufacturer’s clinical evaluation and related documents. CEARs in this format will also support specific additional requirements such as the clinical evaluation consultation procedure and reviews by designating authorities.
A harmonised CEAR template provides a standardised method for documenting the notified body’s assessment of the manufacturer’s clinical evaluation and related documents. CEARs in this format will also support specific additional requirements such as the clinical evaluation consultation procedure and reviews by designating authorities.
JULY 17, 2020_AUSTRALIA (tga)
Actual and potential harm caused by medical software : A rapid literature review of safety and performance issues
A rapid search of published articles using MEDLINE and Pubmed was conducted by the TGA of studies and reviews that specifically reported on medical software safety and efficacy over the last seven years were identified. The search include both mobile apps and medical software used for purposes which included screening, diagnosis, management or monitoring and operating medical equipment. Other relevant papers were identified using Google Scholar.
Therefore while many of the studies cited relate specifically to challenges with software as a medical device, and software controlling medical devices, some additional reports of safety and performance issues with medical software have also been included for context.
A rapid search of published articles using MEDLINE and Pubmed was conducted by the TGA of studies and reviews that specifically reported on medical software safety and efficacy over the last seven years were identified. The search include both mobile apps and medical software used for purposes which included screening, diagnosis, management or monitoring and operating medical equipment. Other relevant papers were identified using Google Scholar.
Therefore while many of the studies cited relate specifically to challenges with software as a medical device, and software controlling medical devices, some additional reports of safety and performance issues with medical software have also been included for context.
JULY 9, 2020_FRANCE (CCAM)
CCAM Version 64
La V64 permet la création des actes JDLD659 et YYYY185, la modification des actes JDLD659, YYYY185, DGLF012, HBQD001, HBMD351, HBMD460, HBLD745, HBJA003, HBJA171, HBJA634, JKHD001, YYYY183 ainsi que la suppression de l’acte BZQP002 au 08/08/20. Elle porte également des modifications de tarifs au 01
La V64 permet la création des actes JDLD659 et YYYY185, la modification des actes JDLD659, YYYY185, DGLF012, HBQD001, HBMD351, HBMD460, HBLD745, HBJA003, HBJA171, HBJA634, JKHD001, YYYY183 ainsi que la suppression de l’acte BZQP002 au 08/08/20. Elle porte également des modifications de tarifs au 01
JULY 8, 2020_EUROPE (NANDO)
Designation for MDR
Congratulations to GMED (CE0459) the 15th Notified Body to be designated under Regulation (EU) 2017/745.
Congratulations to GMED (CE0459) the 15th Notified Body to be designated under Regulation (EU) 2017/745.
JULY 7, 2020_EUROPE (european commission)
Declaration of interest (DOI) form - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
The form consists of two parts: Personal Details and the Public Declaration of Interests. Both parts must be duly completed. The form is designed to be completed electronically and the data entered stored electronically.
The European Commission will publish the declaration of interests on its website.
The form consists of two parts: Personal Details and the Public Declaration of Interests. Both parts must be duly completed. The form is designed to be completed electronically and the data entered stored electronically.
The European Commission will publish the declaration of interests on its website.
JULY 2, 2020_AUSTRALIA (TGA)
Reduced annual charges for medical devices listed on the prostheses list
In response to the suspension of elective surgery due to COVID-19 and the significant impact this has had on parts of the medical devices industry, the Government has agreed to provide a 50 per cent reduction in annual charges for certain medical devices. The 50 per cent reduction in annual charges will be prescribed for the 2020-21 financial year for medical devices included in the Australian Register of Therapeutic Goods (ARTG) as Class IIa, IIb, III and AIMD and which are listed prostheses as defined in the Private Health Insurance (Prostheses) Rules (No.1) 2020, as in force on 8 April 2020.
In response to the suspension of elective surgery due to COVID-19 and the significant impact this has had on parts of the medical devices industry, the Government has agreed to provide a 50 per cent reduction in annual charges for certain medical devices. The 50 per cent reduction in annual charges will be prescribed for the 2020-21 financial year for medical devices included in the Australian Register of Therapeutic Goods (ARTG) as Class IIa, IIb, III and AIMD and which are listed prostheses as defined in the Private Health Insurance (Prostheses) Rules (No.1) 2020, as in force on 8 April 2020.
JUNE 19, 2020_UK (MHRA)
Register as a manufacturer to sell medical devices
Manufacturers are no longer required to fill out forms.
Manufacturers are no longer required to fill out forms.
JUNE 17, 2020_CHINA (cmdE)
New procedures released for medical device registration in China
CMDE) issued two announcements recently outlining revised procedures relating to medical device registration.
CMDE) issued two announcements recently outlining revised procedures relating to medical device registration.
- CMDE Announcement No. 16 of 2020 [links are in Mandarin] establishes procedures and requirements that provide further standardization of the administrative filing review for registration applications, including the acceptance of corrections. This complements the initial batch of filing review requirements laid out in Announcement No. 42 of 2019, which began trial implementation on September 1, 2019.
- CMDE Announcement No. 17 of 2020 stipulates registration withdrawal and re-application procedures for imported medical devices that were submitted for registration as Class II devices but upon technical review were found to fall into Class III.
In such cases, the CMDE will issue a medical device/IVD reagent non-approval document stating the reasons for the non-registration. A copy of this document is required to be included in the documents submitted during the re-application process, along with an explanation of the circumstances leading to the re-application. The application fee already paid for Class II registration will be applied toward re-registration, and the applicant will be required to pay the remainder of the Class III fee.
JUNE 17, 2020_INTERNATIONAL (ISO)
ISO/TR 24971:2020 Medical devices — Guidance on the application of ISO 14971
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019.
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019.
JUNE 16, 2020_EUROPE (EUROPEAN COMMISSION)
European Commission issues decision on harmonized standards for MDR, IVDR
On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of standards under the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Overseeing harmonization of standards falls to the European Commission.
On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of standards under the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Overseeing harmonization of standards falls to the European Commission.
JUNE 16, 2020_AUSTRALIA (TGA)
Proposed delayed commencement of certain medical device regulatory changes
Reflecting the challenges identified by the medical devices industry and healthcare professionals as they have focussed on the COVID-19 crisis, the Australian Government intends asking the Governor General in Council to agree to the proposed delay of the commencement of a number of medical device reforms.
The Australian Medical Device Regulations would be amended to delay implementation of the reforms from 25 August 2020 to:
Reflecting the challenges identified by the medical devices industry and healthcare professionals as they have focussed on the COVID-19 crisis, the Australian Government intends asking the Governor General in Council to agree to the proposed delay of the commencement of a number of medical device reforms.
The Australian Medical Device Regulations would be amended to delay implementation of the reforms from 25 August 2020 to:
- 25 November 2021 for reclassification of certain devices (spinal implants, active implantable MD...)
- 25 February 2021 for medical device software
- 25 February 2021 for personalised medical devices (including 3D printed devices) and
- 25 November 2021 for systems or procedure packs
JUNE 9, 2020_MALAYSIA (MDA)
Malaysia implements adverse events reporting requirements for medical devices
On July 1st, 2020 the Malaysia Medical Device Authority (MDA) will implement the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.
The MDA categorizes recalls into 3 categories: Class I, Class II and Class III, with Class I being the highest risk. For Class I recalls, the establishment must notify the Authority and all persons affected by the recall no less than 48 hours before the recall is made. For Class II recalls, the notice must be made no less than 3 days before and for Class III, no less than 5 days.
The MDA has aligned their reporting process with the AMDD and requires establishments to immediately conduct an investigation upon identifying an AE. Establishments must submit a mandatory report in order to determine if a Field Safety Corrective Action (FSCA) is required. Manufacturers are able to perform FSCAs at any time, but must notify the MDA beforehand and then provide a report to formally close out the issue. After the mandatory report, the establishment is required to submit an investigation report within 30 days, identifying the steps they have taken to correct the issue. Like the AMDD, the MDA reserves the right to require the establishment to take additional steps to protect the public’s health, which includes mandatory recalls.
Record keeping is a fundamental requirement in both the AMDD and the MDA’s guidance. Record keeping is a crucial component of an effective Post-Market Vigilance system, as it ensures establishments can quickly identify where their products are in the case of a recall or corrective/preventive action. Both the AMDD and the MDA require complaints to be maintained for at least 5 years past the useful life of the product. Additionally, distribution records must be kept for at least 2 years or for the duration of the projected useful life as stated by the manufacturer in the technical documentation. Distribution records must contain the consignee, the specifications of the device, the place of storage, details about the delivery and receipt, and details about the disposal of the device. In addition to these requirements, the MDA stipulates that establishments marketing implantable devices maintain information on the healthcare facility that performed the procedure, the details of the patient, the date of implantation and details of removal of the implant, if applicable.
On July 1st, 2020 the Malaysia Medical Device Authority (MDA) will implement the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.
The MDA categorizes recalls into 3 categories: Class I, Class II and Class III, with Class I being the highest risk. For Class I recalls, the establishment must notify the Authority and all persons affected by the recall no less than 48 hours before the recall is made. For Class II recalls, the notice must be made no less than 3 days before and for Class III, no less than 5 days.
The MDA has aligned their reporting process with the AMDD and requires establishments to immediately conduct an investigation upon identifying an AE. Establishments must submit a mandatory report in order to determine if a Field Safety Corrective Action (FSCA) is required. Manufacturers are able to perform FSCAs at any time, but must notify the MDA beforehand and then provide a report to formally close out the issue. After the mandatory report, the establishment is required to submit an investigation report within 30 days, identifying the steps they have taken to correct the issue. Like the AMDD, the MDA reserves the right to require the establishment to take additional steps to protect the public’s health, which includes mandatory recalls.
Record keeping is a fundamental requirement in both the AMDD and the MDA’s guidance. Record keeping is a crucial component of an effective Post-Market Vigilance system, as it ensures establishments can quickly identify where their products are in the case of a recall or corrective/preventive action. Both the AMDD and the MDA require complaints to be maintained for at least 5 years past the useful life of the product. Additionally, distribution records must be kept for at least 2 years or for the duration of the projected useful life as stated by the manufacturer in the technical documentation. Distribution records must contain the consignee, the specifications of the device, the place of storage, details about the delivery and receipt, and details about the disposal of the device. In addition to these requirements, the MDA stipulates that establishments marketing implantable devices maintain information on the healthcare facility that performed the procedure, the details of the patient, the date of implantation and details of removal of the implant, if applicable.
JUNE 4, 2020_EUROPE (EUROPEAN COMMISSION)
European Commission lays out timeline for next steps toward MDR, IVDR
The European Commission has set out its latest timeline for the completion of implementing acts and other activities critical to the incoming Medical Device and In Vitro Diagnostic Regulations.
The implementing acts concern:
• reprocessing of single-use devices;
• specifications for devices without a medical purpose;
• the designation of expert laboratories;
• designations and rules pertaining to EU reference laboratories for IVDs;
• EUDAMED support and maintenance;
• and common specifications for high risk (Class D) diagnostics.
The European Commission has set out its latest timeline for the completion of implementing acts and other activities critical to the incoming Medical Device and In Vitro Diagnostic Regulations.
The implementing acts concern:
• reprocessing of single-use devices;
• specifications for devices without a medical purpose;
• the designation of expert laboratories;
• designations and rules pertaining to EU reference laboratories for IVDs;
• EUDAMED support and maintenance;
• and common specifications for high risk (Class D) diagnostics.
MAY 20, 2020_SOUTH KOREA (MFDS)
South Korea adds renewal requirement for new medical device authorizations
South Korea’s Ministry of Food and Drug Safety (MFDS) published a revision to Article 49 of the Medical Devices Act (Act No. 17248, link in Korean) on April 4, establishing that medical device authorizations issued by the MFDS after October 8, 2020 will only remain valid for five years. This change applies to all device classes, whether authorization was obtained through notification or pre-market approval.
Under the revised law, it will be possible for manufacturers to renew device authorizations for subsequent five-year periods. A further requirement stipulates that registration holders must have imported the device in question into the South Korean market within the authorization period in order to be eligible for renewal.
The MFDS is expected to issue a separate revision stating any additional renewal requirements for medical devices that are already authorized (or will be prior to October 8). Previous to this amendment of the law, manufacturers of Class II and higher devices were required to renew Korea Good Manufacturing Practice (KGMP) certification every three years, but marketing authorizations did not expire.
South Korea’s Ministry of Food and Drug Safety (MFDS) published a revision to Article 49 of the Medical Devices Act (Act No. 17248, link in Korean) on April 4, establishing that medical device authorizations issued by the MFDS after October 8, 2020 will only remain valid for five years. This change applies to all device classes, whether authorization was obtained through notification or pre-market approval.
Under the revised law, it will be possible for manufacturers to renew device authorizations for subsequent five-year periods. A further requirement stipulates that registration holders must have imported the device in question into the South Korean market within the authorization period in order to be eligible for renewal.
The MFDS is expected to issue a separate revision stating any additional renewal requirements for medical devices that are already authorized (or will be prior to October 8). Previous to this amendment of the law, manufacturers of Class II and higher devices were required to renew Korea Good Manufacturing Practice (KGMP) certification every three years, but marketing authorizations did not expire.
may 15, 2020_EUROPE (NANDO)
Designation MDR
Intertek Medical Notified Body AB (NB 2862) is the 14th Notified Body to be designated under Regulation (EU) 2017/745
Intertek Medical Notified Body AB (NB 2862) is the 14th Notified Body to be designated under Regulation (EU) 2017/745
mAY 14, 2020_EUROPE(TEAM-NB)
Validity of the CE/ISO certificates
Team-NB members have means to help you to check the validity of the certificates; please find them in the linked document.
Team-NB members have means to help you to check the validity of the certificates; please find them in the linked document.
aPRIL 24, 2020_EUROPE (eUROPA)
Publication of the Consolidated text of Regulation (EU) 2017/ 745 amended by Regulation (EU) 2020/561
APRIL 24, 2020_EUROPE (EUROPEAN COMMISSION)
Publication of 4 news MDCG documents
- MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies https://ec.europa.eu/docsroom/documents/40903?locale=en
- MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies https://ec.europa.eu/docsroom/documents/40904?locale=en
- MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies https://ec.europa.eu/docsroom/documents/40905?locale=en
- MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies https://ec.europa.eu/docsroom/documents/40906?locale=en
APRIL 24, 2020_EUROPE (joue)
Publication in the Official Journal of the European Union
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
MDR is officially postponed of 1 year => May 26th, 2021.
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
MDR is officially postponed of 1 year => May 26th, 2021.
april 20, 2020_EUROPE (european PARLIAMENT)
Text adopted April 17, 2020 / Medical Device Regulation 2017/745
The amending Regulation (UE) 2017/745 on medical devices has been approved by the European Parliament. => Still have to wait for the publication of the adopted regulation in the Official Journal.
Extension of the transitional period that started in 2017 by one year, by postponing from 26 May 2020 to 26 May 2021 the application of most of the provisions of Regulation (EU) 2017/745 and, for the same reason, to defer the repeal of most of the provisions of the two Directives until 26 May 2021.
The amending Regulation (UE) 2017/745 on medical devices has been approved by the European Parliament. => Still have to wait for the publication of the adopted regulation in the Official Journal.
Extension of the transitional period that started in 2017 by one year, by postponing from 26 May 2020 to 26 May 2021 the application of most of the provisions of Regulation (EU) 2017/745 and, for the same reason, to defer the repeal of most of the provisions of the two Directives until 26 May 2021.
april 20, 2020_INTERNATIONAL (IMDRF)
Publication of 5 new documents
- IMDRF/CYBER WG/N60FINAL:2020: Principles and Practices for Medical Device Cybersecurity http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-pp-mdc-n60.pdf
- IMDRF/GRRP WG/N59FINAL:2020: Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-rrar-cab-cmdrr-n59.pdf
- IMDRF/PMD WG/N58FINAL:2020: Personalized Medical Devices - Regulatory Pathways http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-pmd-rp-n58.pdf
- IMDRF/AE WG/N43FINAL:2020 (Edition 4): IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-ae-terminologies-n43.pdf
- IMDRF/AE WG/N44 FINAL:2020 (Edition 3): Maintenance of IMDRF AE Terminologies http://www.imdrf.org/docs/imdrf/final/procedural/imdrf-proc-200318-ae-terminologies-n44.pdf
APRIL 16, 2020_AUSTRALIA (TGA)
Medical device labelling obligations
This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations. Labelling refers to labels and other information that must be provided with a medical device.
This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations. Labelling refers to labels and other information that must be provided with a medical device.
APRIL 10, 2020_HEALTH CANADA
Private Label Medical Device
This document was updated to reflect the new cost recovery regulations entitled Fees in Respect of Drugs and Medical Devices Regulations. The new regulations exempt Private Label medical devices from review fees associated with licence applications and licence amendment applications.
- Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device
This document was updated to reflect the new cost recovery regulations entitled Fees in Respect of Drugs and Medical Devices Regulations. The new regulations exempt Private Label medical devices from review fees associated with licence applications and licence amendment applications.
- Application for a New Medical Device Licence for a Private Label Medical Device
APRIL 8, 2020_EUROPE (EUROPEAN COMMISSION)
MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
This guidance is intended to cover the following audits notified bodies are requested to carry out as part of medical devices conformity assessments:
This guidance is intended to cover the following audits notified bodies are requested to carry out as part of medical devices conformity assessments:
- surveillance audits under the medical devices Directives,
- audits conducted for re-certification purposes under the medical devices Directives,
- in cases where a manufacturer submits a change notification to a notified body that would typically require on-site audit or verification,
- in cases where a manufacturer terminates (voluntarily or involuntarily) its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device(s).
APRIL 7, 2020_EUROPE (EUROPEAN COMMISSION)
Update of the document MDCG 2019-3 Interpretation of Article 54(2)b rev 1
Addendum on procedural aspects
Addendum on procedural aspects
APRIL 3, 2020_EUROPE (EUROPEAN COMMISSION)
Proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions
The aim of the proposal is to delayed the implementation of the regulation 2017/745: ’26 May 2020’ => ’26 May 2021
Document available in DE, FR and EN
The aim of the proposal is to delayed the implementation of the regulation 2017/745: ’26 May 2020’ => ’26 May 2021
Document available in DE, FR and EN
APRIL 3, 2020_INTERNATIONAL (ISO)
Covid-19 response: Freely available ISO Standards
The list has been compiled to support global efforts in dealing with the COVID-19 crisis. They are freely available in read-only format.
The list has been compiled to support global efforts in dealing with the COVID-19 crisis. They are freely available in read-only format.
APRIL 3, 2020_EUROPE (SNITEM)
Poster Identifiant Unique du Dispositif (IUD)
A l'occasion d'Europharmat 2019, le Snitem revient sur les applications de l'identifiant unique du dispositif (IUD).
A l'occasion d'Europharmat 2019, le Snitem revient sur les applications de l'identifiant unique du dispositif (IUD).
APRIL 2, 2020_HEALTH CANADA
Fees for Medical Devices
Fees for regulatory activities related to medical devices are currently charged as per the Fees in Respect of Drugs and Medical Devices Regulations under the Financial Administration Act. As of April 1, 2020, fees for medical devices will be charged as per the Fees in Respect of Drugs and Medical Devices Order.
Fees for regulatory activities related to medical devices are currently charged as per the Fees in Respect of Drugs and Medical Devices Regulations under the Financial Administration Act. As of April 1, 2020, fees for medical devices will be charged as per the Fees in Respect of Drugs and Medical Devices Order.
march 30, 2020_EUROPE (EUROPEAN COMMISSION)
Issuance of three guidelines
These 3 guidances aim to assist manufacturers in ramping up production of:
These 3 guidances aim to assist manufacturers in ramping up production of:
- 3D printed products, including 3D equipment caught by the MDD / MDR https://ec.europa.eu/docsroom/documents/40522?locale=en
- Protective equipment (masks, gloves and surgical gowns) with or without a medical purpose https://ec.europa.eu/docsroom/documents/40521?locale=en
- Hydro-alcoholic gel in scope of the EU Biocidal Products Regulation or the EU Cosmetics Regulations https://ec.europa.eu/docsroom/documents/40523?locale=en
MARCH 27, 2020_INTERNATIONAL (IMDRF)
Consultations IMDRF Documents:
These consultations close on Tuesday, 26 May 2020
These consultations close on Tuesday, 26 May 2020
- Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
- Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
MARCH 27, 2020_EUROPE (EUROPEAN COMMISSION)
New 2020 lists of harmonised standards for medical devices are now available
The new lists of references of harmonised standards for medical devices have been published (OJ L 901 of 25 May 2020)
The new lists of references of harmonised standards for medical devices have been published (OJ L 901 of 25 May 2020)
MARCH 17, 2020_UK (MHRA)
Guidance Decide if your product is a medicine or a medical device
Update to MHRA’s Guidance Note 8: A guide to what is a medicinal product
A guide to what is a medicinal product_March 2020
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/872742/GN8_FINAL_10_03_2020__combined_.pdf
Update to MHRA’s Guidance Note 8: A guide to what is a medicinal product
A guide to what is a medicinal product_March 2020
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/872742/GN8_FINAL_10_03_2020__combined_.pdf
MARCH 17, 2020_EUROPE (EUROPEAN COMMISSION)
MDCG documents updated and new documents
- MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
- MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
- MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
- MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
MARCH 16, 2020_Hong kong (MDC O)
Hong Kong regulator will continue to recognize South Korean approvals
The Medical Device Control Office (MDCO), announced an extension of its trial program leveraging marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea. The program allows Local Responsible Persons (LRPs) to demonstrate that their medical devices conform to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference TR-004), by presenting MFDS approvals as evidence of satisfying the Medical Device Administrative Control System’s (MDACS) conformity assessment requirements.
The Medical Device Control Office (MDCO), announced an extension of its trial program leveraging marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea. The program allows Local Responsible Persons (LRPs) to demonstrate that their medical devices conform to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference TR-004), by presenting MFDS approvals as evidence of satisfying the Medical Device Administrative Control System’s (MDACS) conformity assessment requirements.
MARCH 16, 2020_EUROPE (EUROPEAN COMMISSION)
MDCG 2020-3_Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
This guidance document is intended to provide clarification on the changes to a device that should be considered a “significant change in design or a significant change in the intended purpose” under MDR Article 120(3). Assessments should be made on a case-by-case basis.
This guidance document is intended to provide clarification on the changes to a device that should be considered a “significant change in design or a significant change in the intended purpose” under MDR Article 120(3). Assessments should be made on a case-by-case basis.
MARCH 12, 2020_FRANCE (HAS)
Identification individuelle pour une inscription en ligne générique des dispositifs médicaux_Délais accordés
Entre le 1er novembre 2019 et le 1er janvier 2020, Le « code d’identification individuel » devait progressivement remplacer les codes génériques pour permettre le remboursement des produits inscrits à la « Liste des Produits et Prestations » (LPP).
En raison du grand nombre de dossiers reçus et du délai de traitement nécessaire à l’attribution des codes individuels, une tolérance vient d’être accordée qui permettra d’utiliser soit le code LPP générique, soit le code d’identification individuel jusqu’aux échéances suivantes :
– Pour les titres 1, 2 et 4 : jusqu’au 1er juillet 2020 ;
– Pour la nomenclature Optique médicale : jusqu’au 1er octobre 2020.
Pour les titres 3 et 5, la date initiale du 1er novembre 2019 avait déjà été repoussée au 1er janvier 2020.
Entre le 1er novembre 2019 et le 1er janvier 2020, Le « code d’identification individuel » devait progressivement remplacer les codes génériques pour permettre le remboursement des produits inscrits à la « Liste des Produits et Prestations » (LPP).
En raison du grand nombre de dossiers reçus et du délai de traitement nécessaire à l’attribution des codes individuels, une tolérance vient d’être accordée qui permettra d’utiliser soit le code LPP générique, soit le code d’identification individuel jusqu’aux échéances suivantes :
– Pour les titres 1, 2 et 4 : jusqu’au 1er juillet 2020 ;
– Pour la nomenclature Optique médicale : jusqu’au 1er octobre 2020.
Pour les titres 3 et 5, la date initiale du 1er novembre 2019 avait déjà été repoussée au 1er janvier 2020.
MARCH 12, 2020_USA (FDA)
Guidance 510(k) Third Party Review Program
Document issued on March 12, 2020
The objectives of this guidance are:
1. To describe the factors FDA will use in determining device type eligibility for review by 3P510k Review Organizations
2. To outline FDA’s process for the recognition, rerecognition, suspension, and withdrawal of recognition for 3P510k Review Organizations
3. To ensure consistent quality of work among 3P510k Review Organizations through the Medical Device User Fee Amendments (MDUFA) IV commitments authorized under FDARA to eliminate the need for routine, substantive re-review by FDA.
Document issued on March 12, 2020
The objectives of this guidance are:
1. To describe the factors FDA will use in determining device type eligibility for review by 3P510k Review Organizations
2. To outline FDA’s process for the recognition, rerecognition, suspension, and withdrawal of recognition for 3P510k Review Organizations
3. To ensure consistent quality of work among 3P510k Review Organizations through the Medical Device User Fee Amendments (MDUFA) IV commitments authorized under FDARA to eliminate the need for routine, substantive re-review by FDA.
MARCH 10, 2020_BRAZIL (ANVISA)
New rules for managing changes to MDs
ANVISA published a press release (in Portuguese) to announce changes in the management of modifications to medical devices, which will come into effect on April 1, 2020.
The modifications are classified into 3 categories:
1. Modifications requiring prior approval from ANVISA (in the event of a high health impact)
2. Immediate application modifications, without prior approval required (in case of moderate health impact): it is authorized as soon as the modification declaration is sent to ANVISA, but audits will be carried out to ensure that the devices modified remain in compliance with the requirements. It is important to emphasize that any change must respect the rules of Good Manufacturing Practices (Brazilian).
3. Non-declarable changes (minor health impact): they can be implemented at any time by the company.
ANVISA published a press release (in Portuguese) to announce changes in the management of modifications to medical devices, which will come into effect on April 1, 2020.
The modifications are classified into 3 categories:
1. Modifications requiring prior approval from ANVISA (in the event of a high health impact)
2. Immediate application modifications, without prior approval required (in case of moderate health impact): it is authorized as soon as the modification declaration is sent to ANVISA, but audits will be carried out to ensure that the devices modified remain in compliance with the requirements. It is important to emphasize that any change must respect the rules of Good Manufacturing Practices (Brazilian).
3. Non-declarable changes (minor health impact): they can be implemented at any time by the company.
MARCH 10, 2020_INTERNATIONAL (IMDRF)
Proposed Document by the International Medical Device Regulators Forum (IMDRF) "Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies"
This consultation closes on Saturday, 9 May 2020.
This document defines the content of the Regulatory Assessment Program and provides guidance on the process-based assessment method. The Assessment Program defines how Regulatory Authorities will recognize, surveil, and re-recognize CABs that review medical devices or IVD medical device marketing submissions and may perform other related functions.
This consultation closes on Saturday, 9 May 2020.
This document defines the content of the Regulatory Assessment Program and provides guidance on the process-based assessment method. The Assessment Program defines how Regulatory Authorities will recognize, surveil, and re-recognize CABs that review medical devices or IVD medical device marketing submissions and may perform other related functions.
MARCH 9, 2020_USA (FDA)
Guidance for Industry and Food and Drug Administration Staff "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery"
FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in general surgery. These devices are designed to cut and/or remove tissue and control bleeding through the use of high-frequency electrical current. For the purpose of this guidance, electrosurgical devices may also be called radiofrequency (RF) devices or high-frequency (HF) devices.
FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in general surgery. These devices are designed to cut and/or remove tissue and control bleeding through the use of high-frequency electrical current. For the purpose of this guidance, electrosurgical devices may also be called radiofrequency (RF) devices or high-frequency (HF) devices.
march 5, 2020_EUROPE (BSI)
Infographic on Post-Market Surveillance under MDR
- What PMS data should be gathered
- How it should be gathered
- Timescales for updates, review and validation
- How PMS data should be used
- What PMS data should be gathered
- How it should be gathered
- Timescales for updates, review and validation
- How PMS data should be used
MARCH 1, 2020_SOUTH KOREA (MFDS)
South Korea imposes new packaging, labeling requirements on medical devices
Medical devices exported to South Korea are subject to new packaging and labeling requirements under guidance issued by the Ministry of Food and Drug Safety that went into effect in January. The new regulations, in the pipeline for a year, had been expected. They clarify labeling requirements to mandate the inclusion of expiration dates, usage plans, and whether a device is intended solely for the purpose of conducting research. The regulations also expand the number and type of medical devices subject to regulation.
Medical devices exported to South Korea are subject to new packaging and labeling requirements under guidance issued by the Ministry of Food and Drug Safety that went into effect in January. The new regulations, in the pipeline for a year, had been expected. They clarify labeling requirements to mandate the inclusion of expiration dates, usage plans, and whether a device is intended solely for the purpose of conducting research. The regulations also expand the number and type of medical devices subject to regulation.
FEBRUARY 28, 2020_FRANCE (HAS)
Webinaire HAS sur l'évaluation des dispositifs médicaux du 27 février 2020
Partie 1 : Préparer son dossier
- Mettre en valeur mes données cliniques
- Estimer ma population cible
- Spécificités des DM connectés & IA
Partie 2 : Déposer son dossier
- Démonstration de la plateforme sésame
Avec l’intervention de Nadia Naour, Corinne Collignon et Romain Aubourg du service d’évaluation des dispositifs médicaux de la HAS.
Partie 1 : Préparer son dossier
- Mettre en valeur mes données cliniques
- Estimer ma population cible
- Spécificités des DM connectés & IA
Partie 2 : Déposer son dossier
- Démonstration de la plateforme sésame
Avec l’intervention de Nadia Naour, Corinne Collignon et Romain Aubourg du service d’évaluation des dispositifs médicaux de la HAS.
FEBRUARY 26, 2020_SINGAPORE (HSA)
Publication of a number of revised guidance and technical reference documents
Version and cybersecurity requirements for software registration
The HSA also updated the Guidance on Change Notification for Registered Medical Devices (GN-21-R4.7) and the Guidance Document for IVD Analyzers (GN-34-R1.3). GN-21-R4.7 now provides details about bundled notification changes, and various revisions were made to the flow charts and documentary requirements tables. GN-34-R1.3 was updated to provide further explanation for the SMDR listing options for closed-system IVD analyzers, as well as the relevant change notification applications. This revision also includes updated process flowcharts and modified definitions.
Version and cybersecurity requirements for software registration
- TR-02-R1: Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices Using the ASEAN CSDT
- E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS
- E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF Toc based Submissions in MEDICS
- TR-01-R1: Contents of a Product Registration Submission for General Medical Devices using the ASEAN CSDT
The HSA also updated the Guidance on Change Notification for Registered Medical Devices (GN-21-R4.7) and the Guidance Document for IVD Analyzers (GN-34-R1.3). GN-21-R4.7 now provides details about bundled notification changes, and various revisions were made to the flow charts and documentary requirements tables. GN-34-R1.3 was updated to provide further explanation for the SMDR listing options for closed-system IVD analyzers, as well as the relevant change notification applications. This revision also includes updated process flowcharts and modified definitions.
FEBRUARY 25, 2020_HEALTH CANADA
Electronic submissions of medical device clinical trial data
Health Canada has begun accepting some clinical trial-related information from sponsors via electronic submissions. Sponsors may now utilize the regulator’s recently developed electronic Common Technical Document (eCTD) format to file certain clinical trial regulatory activities. The eCTD format was made available following a Health Canada pilot period that concluded in August 2019.
Using eCTD for clinical trial regulatory activity submissions is currently optional, but once a sponsor has made a filing to Health Canada using the eCTD format, that sponsor must provide all additional data pertaining to the same protocol via eCTD.
Health Canada identifies the following clinical trial regulatory activities as eligible for eCTD submissions:
Health Canada has begun accepting some clinical trial-related information from sponsors via electronic submissions. Sponsors may now utilize the regulator’s recently developed electronic Common Technical Document (eCTD) format to file certain clinical trial regulatory activities. The eCTD format was made available following a Health Canada pilot period that concluded in August 2019.
Using eCTD for clinical trial regulatory activity submissions is currently optional, but once a sponsor has made a filing to Health Canada using the eCTD format, that sponsor must provide all additional data pertaining to the same protocol via eCTD.
Health Canada identifies the following clinical trial regulatory activities as eligible for eCTD submissions:
- Pre-clinical trial application consultation meetings (PRE-CTA);
- Clinical trial applications (CTAs) using either seven-day administrative or 30-day default performance standards;
- CTA notifications (CTA-N);
- Any responses and post-clearance data pertaining to regulatory activities mentioned above.
february 25, 2020_AUSTRALIA (TGA)
Brexit - Implications for therapeutic goods in Australia
The United Kingdom (UK) exited the European Union (EU) on 31 January 2020.
A transition period is in effect until the end of 2020 while the UK and EU negotiate additional arrangements. The current rules, including those for therapeutic goods, for the UK and EU will continue to apply during the transition period.
At the end of the transitional period, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. This will apply to both existing Australian Register of Therapeutic Goods (ARTG) entries and applications for new inclusions of medical devices in ARTG.
The United Kingdom (UK) exited the European Union (EU) on 31 January 2020.
A transition period is in effect until the end of 2020 while the UK and EU negotiate additional arrangements. The current rules, including those for therapeutic goods, for the UK and EU will continue to apply during the transition period.
At the end of the transitional period, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. This will apply to both existing Australian Register of Therapeutic Goods (ARTG) entries and applications for new inclusions of medical devices in ARTG.
FEBRUARY 24, 2020_FRANCE (AFNOR)
XP S99-223 Dispositifs médicaux - Gestion du rapport bénéfice/risque
Information du passage en statut "norme publiée"
Information du passage en statut "norme publiée"
FEBRUARY 22, 2020_FRANCE (HAS)
Forfait innovation
Mise à jour de la procédure d’élaboration des avis du Collège de la HAS en vue de la prise en charge dérogatoire d’un dispositif médical, d’un dispositif médical de diagnostic in vitro ou d’un acte innovant La prise en charge dérogatoire d’un DM, d’un DM-DIV ou d’un acte innovant est décidée par les ministres chargés de la santé et de la sécurité sociale après avis de la Haute Autorité de santé (HAS). L’objectif de ce document est de présenter les principales étapes d’élaboration d’un avis du collège de la HAS en vue de la prise en charge dérogatoire d’un DM, d’un DM-DIV ou d’un acte innovant.
HAS forfait innovation : https://www.has-sante.fr/jcms/c_2035788/fr/forfait-innovation
Mise à jour de la procédure d’élaboration des avis du Collège de la HAS en vue de la prise en charge dérogatoire d’un dispositif médical, d’un dispositif médical de diagnostic in vitro ou d’un acte innovant La prise en charge dérogatoire d’un DM, d’un DM-DIV ou d’un acte innovant est décidée par les ministres chargés de la santé et de la sécurité sociale après avis de la Haute Autorité de santé (HAS). L’objectif de ce document est de présenter les principales étapes d’élaboration d’un avis du collège de la HAS en vue de la prise en charge dérogatoire d’un DM, d’un DM-DIV ou d’un acte innovant.
HAS forfait innovation : https://www.has-sante.fr/jcms/c_2035788/fr/forfait-innovation
FEBRUARY 21, 2020_australia (TGA)
Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
This Regulatory Impact Statement is intended to support the decision on whether or not to introduce regulatory reforms for medical devices that are manufactured for particular patients (personalised medical devices).
This Regulatory Impact Statement is intended to support the decision on whether or not to introduce regulatory reforms for medical devices that are manufactured for particular patients (personalised medical devices).
FEBRUARY 19, 2020_AUSTRALIA (TGA)
Medical device application processing times
Report on TGA processes and timeframes for the regulation of medical devices and access to market_International benchmarking
https://www.tga.gov.au/sites/default/files/medical-device-application-processing-times-report.pdf
Comparison of international approaches and timeframes for pre-market approval of medical devices, including IVD medical devices (Australia UK Netherlands Brazil Singapore Japan USA Canada)
Report on TGA processes and timeframes for the regulation of medical devices and access to market_International benchmarking
https://www.tga.gov.au/sites/default/files/medical-device-application-processing-times-report.pdf
Comparison of international approaches and timeframes for pre-market approval of medical devices, including IVD medical devices (Australia UK Netherlands Brazil Singapore Japan USA Canada)
FEBRUARY 17, 2020_INDIA (cdsco)
Expanded scope of medical device regulations, plus new expedited registration route
- CDSCO has expanded the scope of products falling under medical device regulation in the country, and also established an expedited registration route for some devices.
- CDSCO’s expansion of the definition of a medical device aligns more closely with that of the Global Harmonization Task Force (GHTF), effectively increasing the scope of products that will require registration as devices in order to be sold in India.
February 11, 2020_Australie (TGA)
Researcher considerations for medical devices
This guidance assists researchers of new medical devices, including in vitro diagnostic (IVD) medical devices and software as a medical device (SaMD), to understand the evidence requirements for market authorisation.
To eventually supply a medical device, sponsors need to submit a market authorisation application to the Therapeutic Goods Administration (TGA) to include their medical device in the Australian Register of Therapeutic Goods (ARTG).
This guidance provides:
This guidance assists researchers of new medical devices, including in vitro diagnostic (IVD) medical devices and software as a medical device (SaMD), to understand the evidence requirements for market authorisation.
To eventually supply a medical device, sponsors need to submit a market authorisation application to the Therapeutic Goods Administration (TGA) to include their medical device in the Australian Register of Therapeutic Goods (ARTG).
This guidance provides:
FEBRUARY 6, 2020_EUROPE (EUROPEAN COMMISSION)
Regulation (EU) 2017/745 on medical devices
DNV GL Presafe AS for Norway (CE2460) is the 10th Notified Body to be designated under regulation (UE) 2017/745
NANDO list: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
DNV GL Presafe AS for Norway (CE2460) is the 10th Notified Body to be designated under regulation (UE) 2017/745
NANDO list: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
JANUARY 30, 2020_MALAYSIA (MMDA)
Malaysia Health Authority to Require Approval of Medical Device Advertisements, Impose Fees
Medical device manufacturers will require the approval of Malaysia’s Medical Device Authority before they can advertise their products in the country, under a new regulation going into effect July 1. Under the regulation, applications must include a copy of the proposed advertisement, a letter certifying the medical device is legally registered for use in the country, and a processing fee of 1,000 Malaysian Ringgit (about $245 US dollars). Advertisements must clearly display the registration number of the device. The regulation pertains to all advertisements for medical devices, whether in print or broadcast. The regulation has been under consideration since last year, but the particulars of the new requirements were made public in January.
Medical device manufacturers will require the approval of Malaysia’s Medical Device Authority before they can advertise their products in the country, under a new regulation going into effect July 1. Under the regulation, applications must include a copy of the proposed advertisement, a letter certifying the medical device is legally registered for use in the country, and a processing fee of 1,000 Malaysian Ringgit (about $245 US dollars). Advertisements must clearly display the registration number of the device. The regulation pertains to all advertisements for medical devices, whether in print or broadcast. The regulation has been under consideration since last year, but the particulars of the new requirements were made public in January.
JANUARY 29, 2020_UK (MHRA)
Notified bodies for medical devices
Information about withdrawal of Notified Bodies has been added
Information about withdrawal of Notified Bodies has been added
JANUARY 28, 2020_SOUTH KOREA (MFDS)
Issuance of final revisions to regulations for medical device importation requirements
MFDS published the final revisions to two regulatory documents pertaining to medical devices. The final revisions went into effect on January 17, 2020.
MFDS published the final revisions to two regulatory documents pertaining to medical devices. The final revisions went into effect on January 17, 2020.
- Import Requirement Exemptions
- Scarce and Urgently Needed Medical Devices
JANUARY 28, 2020_france (legifrance)
Publication au JORF du 28 janvier 2020 de l'arrêté du 21 janvier 2020 relatif à l’entrée en vigueur de l’obligation pour un distributeur de détenir un accord de distribution avec le fabricant ou son mandataire mentionnée au 2° du I de l’article L. 165-1-1-1 du code de la sécurité sociale
Entrée en vigueur au 1er janvier 2021.
Entrée en vigueur au 1er janvier 2021.
JANUARY 27, 2020_UK (MHRA)
Clinical investigations of medical devices – guidance for manufacturers
Publication of the updated guidance => Revised section ‘Is a clinical investigation required: the practical decisions’
Publication of the updated guidance => Revised section ‘Is a clinical investigation required: the practical decisions’
JANUARY 25, 2020_PHILIPPINES (DOH)
Philippines officially launches new medical devices regulations
Initial implementation of DOH Administrative Order 2018-002 (the new Medical Device Rules) was made official with the publication of FDA Circular 2020-0001 on January 23. The implementation plan has Class B, C and D Notified devices (as in listed in FDA Memo 2014-005) requiring a Certificate of Medical Device Registration (CMDR) by February 7, 2020. Likewise, all Class A device will require a Certificate of Medical Device Notification (CMDN) at implementation. Note that existing Certificates of Product Registration (CPR) issued under the old Rules will remain valid until their expiration date, and Certificates of Exemption (COE) will remain valid until November 3, 2021 or two years after issuance.
Initial implementation of DOH Administrative Order 2018-002 (the new Medical Device Rules) was made official with the publication of FDA Circular 2020-0001 on January 23. The implementation plan has Class B, C and D Notified devices (as in listed in FDA Memo 2014-005) requiring a Certificate of Medical Device Registration (CMDR) by February 7, 2020. Likewise, all Class A device will require a Certificate of Medical Device Notification (CMDN) at implementation. Note that existing Certificates of Product Registration (CPR) issued under the old Rules will remain valid until their expiration date, and Certificates of Exemption (COE) will remain valid until November 3, 2021 or two years after issuance.
january 21, 2020_SAUDI ARABIA (SFDA)
Saudi FDA extends GHAD deadlines and issues guidance documents
- GHAD migration deadline pushed back
- New guidance for innovative devices and standards
JANUARY 20, 2020_SWITZERLAND (SWISS MEDTECH)
Information for all Swiss manufacturers of medical devices
Swiss manufacturers will have to meet third country requirements for all medical devices (MDR and MDD) namely they should find an Authorized Representative if they don't have any office in one of the EU member state.
The current Mutual Recognition Agreement may no longer be valid after May 26, 2020.
Swiss manufacturers will have to meet third country requirements for all medical devices (MDR and MDD) namely they should find an Authorized Representative if they don't have any office in one of the EU member state.
The current Mutual Recognition Agreement may no longer be valid after May 26, 2020.
JANUARY 14, 2020_EUROPE (SNITEM)
Publication de 2 nouvelles fiches:
- DM ou pas DM : https://www.snitem.fr/le-snitem-en-action/les-publications/dm-ou-pas-dm
- Logiciel et intelligence artificielle (IA) : https://www.snitem.fr/le-snitem-en-action/les-publications/logiciel-et-ia
Toutes les fiches mnémotechniques réunies dans une bibliothèque : https://www.snitem.fr/le-snitem-en-action/les-publications/toutes-les-fiches-mnemotechniques-reunies-dans-une-bibliotheque
- DM ou pas DM : https://www.snitem.fr/le-snitem-en-action/les-publications/dm-ou-pas-dm
- Logiciel et intelligence artificielle (IA) : https://www.snitem.fr/le-snitem-en-action/les-publications/logiciel-et-ia
Toutes les fiches mnémotechniques réunies dans une bibliothèque : https://www.snitem.fr/le-snitem-en-action/les-publications/toutes-les-fiches-mnemotechniques-reunies-dans-une-bibliotheque
JANUARY 14, 2020_AUSTRALIA (TGA)
Uniform recall procedure for therapeutic goods (URPTG)
A new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) (V2.2, December 2019) has been implemented, with effect from 12 December 2019.
This version updates V2.1 to include:
1- additional clarity on the provision of surgeon contact details for implanted therapeutic goods
2- amendments related to the online notification of recall and non-recall actions.
3- removal of the placeholder referring to the National Patient Contact Principles for Patients with Implanted Medical Devices subject to Hazard Alerts
4- a second example template for the sponsor's customer letter.
This version also includes a number of other minor editorial amendments.
https://www.tga.gov.au/publication/uniform-recall-procedure-therapeutic-goods-urptg
A new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) (V2.2, December 2019) has been implemented, with effect from 12 December 2019.
This version updates V2.1 to include:
1- additional clarity on the provision of surgeon contact details for implanted therapeutic goods
2- amendments related to the online notification of recall and non-recall actions.
3- removal of the placeholder referring to the National Patient Contact Principles for Patients with Implanted Medical Devices subject to Hazard Alerts
4- a second example template for the sponsor's customer letter.
This version also includes a number of other minor editorial amendments.
https://www.tga.gov.au/publication/uniform-recall-procedure-therapeutic-goods-urptg
JANUARY 8, 2020_INDIA (CDSCO)
India’s CDSCO extends medical device compliance deadlines to 2021
The CDSCO extension means that the following device types, originally expected to register under India’s Medical Device Rules, 2017 by January 1, 2021:
The CDSCO extension means that the following device types, originally expected to register under India’s Medical Device Rules, 2017 by January 1, 2021:
- Nebulizers
- Blood pressure monitoring equipment
- Digital thermometers
- Glucometers
- Implantable devices
- CT scan equipment
- MRI equipment
- Defibrillators
- Dialysis systems
- PET equipment
- X-Ray machines
- Bone marrow cell separation devices
JANUARY 8, 2020_INTERNATIONAL (RAPS FOCUS)
The Essential List of Regulatory Authorities in Asia
To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority.
To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority.
JANUARY 6, 2020_EUROPE (EUROPEAN COMMISSION)
MDCG 2019-16 - Guidance on Cybersecurity for medical devices
The primary purpose of this document is to provide manufacturers with guidance on how to fulfil all the relevant essential requirements of Annex I to the MDR and IVDR with regard to cybersecurity.
However, and in light of the complexity of medical device supply chains and the role played by different operators in ensuring that devices are protected against unauthorised access and possible cyber threats, additional considerations concerning expectations from actors other than manufacturers are provided. In addition, a description of other EU and global pieces of legislation and guidance that are relevant to the domain of cybersecurity for medical devices has been provided in an Annex.
The primary purpose of this document is to provide manufacturers with guidance on how to fulfil all the relevant essential requirements of Annex I to the MDR and IVDR with regard to cybersecurity.
However, and in light of the complexity of medical device supply chains and the role played by different operators in ensuring that devices are protected against unauthorised access and possible cyber threats, additional considerations concerning expectations from actors other than manufacturers are provided. In addition, a description of other EU and global pieces of legislation and guidance that are relevant to the domain of cybersecurity for medical devices has been provided in an Annex.