ARCHIVED List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations (2023-02-23 to 2024-01-02)

Notice to Reader

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

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:

• Medical devices for use in relation to COVID-19

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