Health Canada has announced a policy turnabout regarding the requirements for transitioning to the Medical Device Single Audit Program (MDSAP), which is in response to medical device manufacturers facing audit scheduling challenges. To legally sell devices in the Canadian market, manufacturers will be required to submit MDSAP certificates by 31st December 2018. However, Health Canada has now decided not to take enforcement actions against manufacturers without these certificates if they demonstrate they have undergone a MDSAP audit by the same deadline.
Health Canada has continued to alter its involvement in MDSAP with the aim of facilitating timely transitions, including the reduction in audit times for small-to medium-sized manufacturers, among other changes implemented in October 2017. The MDSAP allows a single audit to satisfy the regulatory requirements of multiple jurisdictions.
The notice from Health Canada states that the new policy adjustment “will make it easier for manufacturers to transition to MDSAP”. The adjustment aims to address the expressed concerns from manufacturers regarding scheduling MDSAP audits “as there is often delay between the timing of the audit and the issuance of the certificate”.
In order to legally sell devices in Canada, until a MDSAP certificate is received, firms transitioning via the surveillance audit process must hold an ISO 13485 certificate under the Canadian Medical Devices Conformity Assessment System that must be valid until at least 31st December 2018, or 1st January 2019 (when the program is set to become operational) if issued by a MDSAP Auditing Organisation. Furthermore, they must have also already completed the arrangements to undergo a full MDSAP certification audit.
Differences in Health Canada’s model from other regions that are covered by the MDSAP consortium, such as Australia, Brazil, Japan and the United States (US), include Health Canada being the only one that will use MDSAP certificates to make determinations on Class II, III and IV devices licenses.
To read more about Health Canada’s adjustments to the MDSAP transition, please click here.