Medical Device Single Audit Program (MDSAP)

Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). All manufacturers holding medical device licences in Canada now participate in the program, which improves Health Canada's oversight of the medical devices sold in Canada, and ensures that the medical devices Canadians use meet higher quality standards. The transition to the MDSAP was initially announced in December 2015 and was completed in 2019.

Auditing process flexibility during the COVID-19 pandemic

On March 24, 2020, the MDSAP Consortium provided updated instructions to all MDSAP Auditing Organisations to deal with the inability to perform audits during the pandemic. Remote MDSAP audits will be allowed, where appropriate and possible. Health Canada supports this approach as it maintains the reliability and integrity of the MDSAP program to the extent possible in the context of the pandemic.

In addition, to support the medical devices manufacturing sector, Health Canada will apply regulatory flexibility during the pandemic, while ensuring that safety requirements are met. This regulatory flexibility will be in place for the duration of the COVID-19 pandemic, and will be re-evaluated by December 31, 2020.

For any questions or concerns related to MDSAP, please contact the Medical Devices Directorate's Quality Systems Unit at hc.qs.mdb.sc@canada.ca.

Medical Device Single Audit Program notices and announcements

Related Medical Device Single Audit Program resources

Medical Device Single Audit Program reports

Medical Device Single Audit Program participant survey

Medical Device Firms and Auditing Organizations participating in the Medical Device Single Audit Program are invited to provide feedback through targeted surveys :

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