List of regulatory agencies for the purposes of sections 61.2 and 68.3 of the Medical Devices Regulations
Date issued: January 3, 2024
Supersedes: February 22, 2023
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.
Health Canada maintains and updates this list as required.
For more information, please refer to:
- Foreign risk notification for medical devices guidance document for details on section 61.2 of the MDR
- Medical devices for an urgent public health need for details on section 68.3 of the MDR
| Regulatory agency | Jurisdiction |
|---|---|
| Therapeutic Goods Administration (TGA) | Australia |
| Austrian Agency for Health and Food Safety (AGES) | Austria |
| Federal Agency for Medicines and Health Products (FAMHP) | Belgium |
| National Health Surveillance Agency (ANVISA) | Brazil |
| Bulgarian Drug Agency | Bulgaria |
| National Medical Products Administration | China |
| Agency for Medicinal Products and Medical Devices of Croatia (HALMED) | Croatia |
| Cyprus Medical Devices Competent Authority | Cyprus |
| State Institute for Drug Control | Czechia |
| Danish Medicines Agency | Denmark |
| Health Board, Medical Devices Department | Estonia |
| Finnish Medicines Agency (FIMEA) | Finland |
| National Agency for the Safety of Medicine and Health Products (ANSM) | France |
| Federal Institute for Drugs and Medical Devices (BfArM) | Germany |
| National Organization for Medicines (EOF) | Greece |
| National Institute of Pharmacy and Nutrition (OGYEI) | Hungary |
| Health Products Regulatory Authority (HPRA) | Ireland |
| Medical Devices and Active Implantable Medical Devices, Ministry of Health | Italy |
| Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) | Japan |
| Ministry of Health of the Republic of Latvia- Health Inspectorate | Latvia |
| State Health Care Accreditation Agency (VASPVT) | Lithuania |
| State Health Care Agency, Ministry of Health | Luxembourg |
| Malta Competition and Consumer Affairs Authority (MCCAA) | Malta |
| Federal Commission for Protection Against Sanitary Risk (COFEPRIS) | Mexico |
| Healthcare and Youth Care Inspectorate (IGZ) | Netherlands |
| Medicines and Medical Devices Safety Authority (MEDSAFE) | New Zealand |
| Office for Registration of Medicinal Products, Medical Devices and Biocidal Products | Poland |
| National Authority of Medicines and Health Products (INFARMED) | Portugal |
| National Agency for Medicines and Medical Devices (NAMMDR) | Romania |
| Russian Ministry of Health | Russia |
| Health Sciences Authority (HSA) | Singapore |
| State Institute for Drug Control (SIDC) | Slovak Republic |
| Agency for Medicinal Products and Medical Devices of the Republic (JAZMP) | Slovenia |
| Ministry of Food and Drug Safety | South Korea |
| Spanish Agency for Medicines and Health Products (AEMPS) | Spain |
| Medical Products Agency (MPA) | Sweden |
| Swiss Agency for Therapeutic Products (Swissmedic) | Switzerland |
| Medicines and Healthcare Products Regulatory Agency (MHRA) | United Kingdom |
| United States Food and Drug Administration (US FDA) | United States of America |
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