ARCHIVED List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations
Notice to Reader
This is an archived list. Please refer to the most current version of this list.
Date issued: 2023-02-22
Supersedes: 2019-09-24
Access the archived version of this list.
This list is incorporated by reference in sections 61.2 and 68.3 of the Medical Devices Regulations (MDR). The list sets out the regulatory agencies for the purposes of these sections.
For more information, please refer to:
- Foreign risk notification for medical devices for details on section 61.2 of the MDR
- Medical devices for use in relation to COVID-19 for details on section 68.3 of the MDR
| Regulatory agency | Jurisdiction |
|---|---|
| Therapeutic Goods Administration | Australia |
| National Health Surveillance Agency (ANVISA) | Brazil |
| United States Food and Drug Administration | United States of America |
| Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare | Japan |
| European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and Small and Medium Enterprises | Europe |
| Health Sciences Authority | Singapore |
| Swissmedic | Switzerland |
| Paul Ehrlich-Institute of Germany | Germany |
| Agence nationale de sécurité du médicament et des produits de santé | France |
| Health Products Regulatory Authority | Ireland |
| National Medical Products Administration | China |
| Russian Ministry of Health | Russia |
| Ministry of Food and Drug Safety | South Korea |
| Medical Products Agency | Sweden |
| Medicines and Healthcare Products Regulatory Agency | United Kingdom |
| Medicines Evaluation Board of the Netherlands and the Dutch Health Care Inspectorate | Netherlands |
| Medicines and Medical Devices Safety Authority (Medsafe) | New Zealand |
| Ministry of Health of the United Mexican States | Mexico |