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

Notice to Reader:

This is an archived list. Please refer to the most current version of this list.

The proposed new section 61.2 of the Medical Devices Regulations requires the reporting of actions that occur in specified foreign jurisdictions. A list of foreign regulatory agencies (below) would be incorporated by reference into the proposed regulations. Under the proposed regulations, medical device license holders and importers for Classes II-IV devices would be required to submit to Health Canada information on any serious risk of injury to human health of which they became aware, and that is a) relevant to the safety of the medical device, and b) the subject of actions intended to reduce risk that have been communicated by:

• any regulatory agency on this list; or
• any person who is authorized to manufacture or sell a medical device within the jurisdiction of any of the regulatory agencies on this list.

Regulatory Agency	Country / Jurisdiction
Therapeutic Goods Administration of the Department of Health and Ageing	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