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.