MDSAP: FAQs Answered
(An article published by Sean Chaudhry, President & Principal Consultant – CanSummit™ Canadian Medical Devices & Diagnostics Consulting on May 22, 2019)
MDSAP has been a topic of great interest to MD&D manufacturers that are either already active in the Canadian market or are planning to enter it. My goal in this article is to demystify this topic in simple, commercial terms and I will like to acknowledge Health Canada website (https://www.canada.ca/en/health-canada.html) as the original reference source for the information contained in this article.:
What is MDSAP?
MDSAP stands for Medical Device Single Audit Program. It is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.
The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Canada, Australia, Brazil, Japan and the United States.
Why is MDSAP important?
In the Canadian context, MDSAP is important because it is a requirement of Health Canada. All manufacturers of class II, III, and IV medical devices sold in Canada are required to transition to the Medical Device Single Audit Program.
Is MDSAP required for class I devices?
No. MDSAP is required for the manufacturers of class II, III, and IV medical devices sold in Canada.
What is the effective date of the MDSAP requirement in Canada?
January 1, 2019. Effective this date MDSAP certification is a mandatory requirement for all manufacturers of class II, III, and IV medical devices sold in Canada.
Who do I work with to obtain MDSAP certification?
MD&D manufacturers will need to work with an authorized or recognized Auditing Organization (AO). These organizations can issue Medical Device Single Audit Program certificates that Health Canada will accept. A list of authorized or recognized Auditing Organizations (AO) can be found here.
Can I hire any auditor of my choice for MDSAP certification?
No. Please refer to our response to the previous question.
What happened to the CMDCAS program requirement?
As of January 1, 2019, the Canadian Medical Devices Conformity Assessment System (CMDCAS) program will end and Canadian Medical Devices Conformity Assessment System certificates will no longer be issued or accepted.
Where can I find more information on MDSAP?
Please visit Health Canada website for further information on MDSAP in Canada.
At CanSummit, we specialize in answering these questions and any other questions you might have about the Canadian market entry for your specific medical devices. To learn more, schedule your no charge introductory consultation, explore our CanSummit™ Canadian MD&D Market Entry System, register for our educational webinars, on the Canadian market, learn more about us, or contact us.
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