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Posted 13 April 2018 | By Ana Mulero 

Health Canada Eases Requirements for MDSAP Transition

In response to medical device manufacturers facing audit scheduling challenges, Health Canada announced Friday a policy turnabout in requirements for transitioning to the Medical Device Single Audit Program (MDSAP).

Manufacturers will be required to submit MDSAP certificates by 31 December 2018 to legally sell devices in the Canada market. 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 tweak its involvement in MDSAP—a cornerstone of the regulatory harmonization initiative launched by the International Medical Device Regulators Forum—with the intention of facilitating timely transitions, including the reduction in audit times for small- to medium-sized manufacturers, among other changes implemented in October 2017.

The program allows a single audit to satisfy the regulatory requirements of multiple jurisdictions.

The new policy adjustment “will make it easier for manufactures to transition to MDSAP,” Health Canada said. It addresses the concerns manufacturers expressed with scheduling MDSAP audits “as there is often delay between the timing of the audit and the issuance of the certificate.”

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 31 December 2018, or 1 January 2019—when the program is set to become operational—if issued by a MDSAP Auditing Organisation.

They must have also already made the arrangements to undergo a full MDSAP certification audit.

Health Canada’s model differs from other regions covered by the MDSAP consortium, such as Australia, Brazil, Japan and the US, in that it is currently the only one that will use MDSAP certificates to make determinations on Class II, III, and IV devices licenses.

Notice: Adjustments to Medical Device Single Audit Program (MDSAP) Transition


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