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:

List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations
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

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