Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) 

Other (TBT)

Drugs and medical devices (ICS codes: 11.120, 11.040)

Link to ePing

11.040 - Medical equipment; 11.040 - Medical equipment; 11.120 - Pharmaceutics; 11.120 - Pharmaceutics

Human health; Human health

The Proposed Regulations were notified to the WTO under G/TBT/N/CAN/694 (dated 19 April 2023).The objectives of these amendments are to strengthen Health Canada’s oversight of therapeutic products sold in Canada and to introduce additional risk-based measures and modern, flexible regulatory tools. These changes will strengthen Health Canada’s ability to provide efficient, effective and agile oversight of drugs and medical devices in a manner that is better aligned with international best practices.The regulations include targeted amendments to the Food and Drug Regulations (FDR) and Medical Devices Regulations (MDR). The amendments will: (i) clarify industry obligations when conducting recalls of therapeutic products; (ii) improve international alignment for voluntary recall requirements in the MDR; (iii) replace the outdated list of foreign regulatory authorities in the table in C.01A.019 in the FDR; (iv) offer conditional exemptions to industry from performing aspects of finished product testing for certain novel and complex biologics and radiopharmaceuticals in the FDR; and (v) modernize establishment licence application requirements and introduce authorities for the Minister to impose terms and conditions on an establishment licence in the MDR to enable targeted compliance and enforcement actions.

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