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

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:

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
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