Notice: Medical Device Single Audit Program (MDSAP) Reduction of Audit Times for Small-sized Enterprises - update
May 4, 2018
Our file number: 18-104835-692
Health Canada has been actively engaging with the medical device industry to support its transition to the new MDSAP program by January 1st, 2019. In light of the comments received, the Department has continued to work in collaboration with the MDSAP Consortium to identify additional opportunities for audit duration reductions.
Additional Adjustments to Audit Duration for Small-sized Enterprises
Further to the reductions in audit times announced by Health Canada on October 31st, 2017, the Department is pleased to announce that it has identified additional opportunities for audit duration reductions in collaboration with the MDSAP Consortium (Canada, USA, Japan, Brazil and Australia).
As a result, manufacturers could benefit from additional reductions in audit duration if they meet the following criteria:
- Have 100 or fewer employees
- Make only lower risk products (typically class II medical devices)
- Use simple design and manufacturing process using commonly available materials and established technologies
- Have a good history of conformity to ISO 13485 and regulatory requirements
Updated MDSAP audit duration calculation procedures have been provided to Auditing Organizations who will apply the adjustments as appropriate. For example, a manufacturer with 15 employees and meeting the above criteria could receive a reduction in audit duration of up to 35%, one with 45 employees could receive a reduction of up to 18%, whereas one with 85 employees could be eligible for an adjustment of up to 10%. The additional reductions will be effective as of June11, 2018.
This proposal has been developed in collaboration with our counterparts at the MDSAP consortium and the reductions are justified on a technical basis. Auditing Organisations will determine the eligibility of each manufacturer (in relation to the above criteria) and apply the audit duration adjustments on a case-by-case basis. Auditing Organisations will determine audit parameters in accordance with ISO 13485. This model existed with the Canadian Medical Device Conformity Assessment System (CMDCAS) program and is maintained with the MDSAP program.
Health Canada remains committed to the smooth transition from the CMDCAS to MDSAP and in providing Canadians with safe and effective medical devices while collaborating with our international partners to reduce regulatory burden on the medical device industry.
Questions or concerns regarding this notice should be directed to:
Quality Systems Division
Medical Devices Bureau
Holland Cross, Tower A
11 Holland Avenue
Address Locator: 3005B
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