List of regulatory agencies and foreign jurisdictions
This list is incorporated into the Medical Devices Regulations. It sets out the regulatory agencies and foreign jurisdictions for the purposes of section 61.2 of the Regulations.
The regulatory agencies and foreign jurisdictions that apply are listed below.
Date issued: December 23, 2020
| 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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