Canada Proposes New Device Regs to Improve Safety
1 July 2019
Posted by: inetika
On June 15, 2019, Health Canada pre-published proposed regulations in Canada Gazette, Part I, to amend the Medical Devices Regulations to:
- Operationalize the powers included in Vanessa’s Law to require assessments, tests and studies by establishing the rules needed to structure the exercise of those powers for medical devices;
- Create new rules for reporting actions in foreign jurisdictions for the highest risk medical devices, which will provide timely and targeted information;
- Require medical device manufacturers to prepare annual summary reports of safety information; and
- Provide the Minister of Health with the power to request that medical device manufacturers provide an analysis of the safety and effectiveness of their product for the purpose of conducting a post-market safety review.
Health Canada’s consultation page can be found here and comments on the proposed regulations can be submitted by email at email@example.com. Additionally, an accompanying draft guidance document has been prepared to provide stakeholders with additional information to help them provide their feedback on the draft regulations. To obtain the draft guidance document, please email MHPD-DPSC.VL-LV@hc-sc.gc.ca.
Stakeholders are invited to provide comments on the regulatory proposal and the draft guidance document by August 26, 2019.