Notice: Medical Device Single Audit Program (MDSAP) Reduction of Audit Times

October 31, 2017
Our file number: 17-112120-288

Health Canada is continuing to work towards the target date of January 1, 2019, to transition to only MDSAP Quality Management System certificates being accepted for medical device licence applications.

As stated in the December 4, 2015, Notice and associated FAQ, Health Canada requires all manufacturers to be compliant by January 1, 2019.

Manufacturers are encouraged to contact their Auditing Organisation to schedule an early transition as Auditing Organisations may not be able to accommodate all requests for transition in late 2018. Both Authorised and Recognised Auditing Organisations can issue MDSAP certificates that will be accepted by Health Canada.

Manufacturers that cannot make the transition to MDSAP by January 1, 2019, will be subject to compliance actions including the potential for cancellation of medical device licences.

Health Canada has received comments from Canadian medical device licence holders regarding the current audit-time model for MDSAP and subsequent annual surveillance audits. To address these comments, the MDSAP Consortium has implemented the following changes:

  • Streamlined the MDSAP audit approach in the revised version of the audit model. This has reduced the total number of tasks to be accomplished and reduced the overall audit time;
  • Introduced a 10% reduction in audit time for manufacturers with 45 or fewer employees;
  • Introduced a 20% reduction in audit time for manufacturers with 15 or fewer employees;
  • Introduced a 20% reduction in the duration of surveillance and re-certification audits  for all manufacturers; and
  • Clarified the expectations for annual surveillance audits with the goal of reducing the audit time.

Other mechanisms to improve efficiency and reduce audit times are also being explored by the MDSAP Consortium and will be announced in the near future. This is intended to align with current audit schemes.

Health Canada remains committed to the smooth transition from the Canadian Medical Devices Conformity Assessment System (CMDCAS) to MDSAP and providing Canadians with safe and effective medical devices while collaborating with our international partners to reduce regulatory burden on the medical device industry.

If you have further questions, please direct them to:

Quality Systems Division
Medical Devices Bureau
Health Canada
Holland Cross, Tower A
11 Holland Avenue
Address Locator: 3005B
Ottawa, ON
K1A 0K9

Telephone: 613-957-4786
Facsimile: 613-946-6758
E-mail: qs_mdb_hc@hc-sc.gc.ca

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