List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations

Date issued: 2023-02-22

This list is incorporated by reference in paragraph 68.11(4)(b) of the Medical Devices Regulations. The list sets out the regulatory agencies for the purposes of section 68.11(4).

For more information, please refer to:

List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations
Regulatory agency Jurisdiction
United States Food and Drug Administration United States of America
Therapeutic Goods Administration Australia
European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and Small and Medium Enterprises Europe
Medicines and Healthcare Products Regulatory Agency United Kingdom
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