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 qs.mdb@hc-sc.gc.ca.

Medical Device Single Audit Program notices and announcements

• Notice: Medical Device Single Audit Program (MDSAP) Transition Plan - Frequently Asked Questions (FAQ) [2018-10-03]
• Notice: Adjustments to Medical Device Single Audit Program (MDSAP) Reduction of Audit Times for Small-sized Enterprises - update [2018-05-04]
• Notice: Adjustments to Medical Device Single Audit Program (MDSAP) Transition [2018-04-13]
• New Candidate AO Participation in the Transitional Phase of the Medical Device Single Audit Program (MDSAP) [2016-11-29]
• Notice: Transition to the Revised Version of ISO 13485 and its impact on the Compliance to the Quality Management System Requirements of the Canadian Medical Devices Regulations [2016-08-16]
• Medical Device ISO 13485:2003 Voluntary Audit Report Pilot Program; Termination of Pilot Program; Announcement of the Medical Device Single Audit Program Operational Phase [2015-12-17]
• Notice: Transition Plan for the Medical Device Single Audit Program (MDSAP) [2015-12-04]
• Japan joins the Medical Device Single Audit Program (MDSAP) [2015-06-23]
• Medical Device Manufacturers Participation in the Medical Device Single Audit Program (MDSAP) Pilot [2015-01-12]
• MDSAP Pilot Announcement [2015-01]
• Federal Register Notice: International Medical Device Regulators Forum, Medical Device Single Audit Program International Coalition Pilot Program [2013-11-15]

Related Medical Device Single Audit Program resources

• ANVISA Resolutions
• CDRH Learn MDSAP Training Modules (Postmarket Activities Section >Inspections-Global Harmonization)
• Medical Device Single Audit Program (MDSAP) Documents, Procedures, Guidelines and Regulations
• Auditing Organization Availability to Conduct MDSAP Audits [2017-12-13]
• Medical Device Single Audit Program (MDSAP) Frequently Asked Questions [2017-08-22]
• Announcement of New MDSAP Training Modules [2016-09-08]
• MDSAP Participation Invitation [2016-09-08]
• MDSAP Regulatory Authority Contact Information [2016-07-11]

Medical Device Single Audit Program reports

• Medical Device Single Audit Report (MDSAP) Final Pilot Report [2017-06-29]
• FDA EIR MDSAP Audit Report Equivalence [2016-11-29]
• Medical Device Single Audit Report (MDSAP) Mid-Pilot Report [2015-08-15]

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 :

• Post-MDSAP Assessment Survey
• Post-MDSAP Audit Survey of Auditors
• Post-MDSAP Audit Survey of Manufacturers