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 |