Post-Market Surveillance of Medical Devices
Canada Gazette, Part I to amend the Regulations regarding the Post-market Surveillance of Medical Devices was posted June 15, 2019. Following the Regulations with respect to drugs that came into force in 2018, as per Vanessa’s Law, the Feds are proposing medical device regulations for Class II, III and IV devices as follows:
- allow the Minister of Health (the Minister) the power to compel an assessment of a marketed therapeutic product
- allow the Minister the power to compel additional tests and studies regarding a marketed therapeutic product
- require product authorization holders to provide information about foreign risk actions for their products
- require medical device manufacturers to prepare annual summary reports
- provide the Minister 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
(Regulations #1, #2, and #3 applied to both drugs and medical devices whereas #4, and #5 are specific to devices).
Enforcing an assessment allows Health Canada to track information on any issues from real world use that may impact the safety of a device and take risk mitigation measures if/when a risk is identified. The results of the assessment will be posted on the Government of Canada website with a description of the action the Minister has taken or may take. The annual summary reports (ASRs) have been required for drugs since 2011 and these amendments will ensure ASRs for medical device regulations (MDRs) align with both the reports for drugs and with those of international standards.
These amendments would require timely reporting of information regarding any actions taken outside of Canada for medical devices that are marketed in Canada, including: risks of the product, changes to labelling, recalls, reassessments, suspensions or revocations of licences.
These regulations will also require medical device manufactures to comply with the specified International Organization for Standardization to ensure harmonization with international standards.
What is this expected to cost? The Feds estimate the new regulations would cost the medical device industry just under $1 million/year or $7.09 million in present value (PV) over 10 years. An estimate of $19,577 per firm was provided as the cost to carry out an annual summary and analysis of safety and effectiveness based on 263 hours and 279 hours of work respectively.
The regulations are open for feedback for 70 days following the date of this Canada Gazette publication.
These amendments to the Regulations were expected and will enable Health Canada to better evaluate medical devices throughout their life cycle (before and after reaching market authorization). Do these costs accurately reflect the amount of work that needs to be carried out to fulfill these new Regulations?