Health Canada Eases MDSAP Deadline, Beefs Up Post-Market Surveillance

Health Canada is sticking to its compliance deadline of Jan. 1, 2019, for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program, but it is making adjustments to help manufacturers comply.

The regulator said it would not take enforcement action if manufacturers have undergone a MDSAP audit by Dec. 31, 2018. The modifications to the transition process were made due to industry comments around scheduling MDSAP audits and the requirement to have a MDSAP certificate by the Dec. 31 deadline.

The agency said it recognizes that some manufacturers are facing challenges in scheduling MDSAP audits in 2018, and may not be issued their MDSAP certificate by Dec. 31, 2018 as there is often a delay between the timing of the audit and the issuance of the certificate.

Device manufacturers that underwent an initial recertification audit to ISO 13485 under CMDCAS will be allowed to transition into the MDSAP during the surveillance audit process, which will allow manufacturers to maintain their existing certification cycles.

Although manufacturers that transition to MDSAP during a surveillance audit won’t receive a MDSAP certificate in 2018, they will be able to continue selling their devices until they receive the certificates.

The regulator clarified that devicemakers transitioning to MDSAP during a surveillance audit will need to show:

• That they have undergone an initial or recertification audit to ISO 13485 under CMDCAS on or after Jan. 1, 2016;
• They hold a valid ISO 13485 certificate issued under CMDCAS that has a validity period to at least Dec. 31, 2018;
• As of Jan. 1, 2019 they continue to hold a valid ISO 13485 certificate issued by a MDSAP Auditing Organization; and
• They have undergone a MDSAP audit or have made arrangements to undergo a MDSAP audit.

Health Canada is working with auditing organizations and is monitoring the transition to mitigate the impact of potential auditor resource shortages. It said most AOs are not seeing difficulty in meeting the MDSAP transition deadline. The biggest challenge is getting manufacturers to agree to schedule their MDSAP audits soon enough to complete the process before the transition deadline (IDDM, Feb. 23).

Increased Post-Market Surveillance

Health Canada is planning on ramping up its post-market surveillance program by providing the Minister of Health with additional authority to request analytical reports from manufacturers when there is “suspicion of a safety concern with a medical device and set out conditions under which the authority would be used.”

The authority would enable the health minister to request the information that was used to create the analytical issue report and “any other information in the manufacturer’s possession deemed necessary to assess the safety of a medical device,” Health Canada said.

Other proposed regulations would provide the authority to compel manufacturers to conduct reassessments and to require tests and studies.

More information will be forthcoming, and guidance will be made available for industry to comment on the proposal.

In addition, Health Canada is establishing a new division within the Medical Devices Bureau to allow for more targeted reviews of digital health technologies to better adapt to rapidly changing technologies and respond to these faster innovation cycles.

The new Digital Health Review Division will focus on wireless medical devices, mobile medical apps, telemedicine, software as a medical device, artificial intelligence, cybersecurity, and medical device interoperability.