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.