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

List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations
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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