Author: Karen Zhou
Manufacturers who sell medical devices in the Canadian market are required to submit MDSAP certificates by December 31, 2018. The Medical Device Single Audit Program (MDSAP) is an international harmonization initiative that allows a single audit to meet the regulatory requirements of five jurisdictions (Canada, United States, Brazil, Australia and Japan). During the transition from CMDCAS to MDSAP, Health Canada has been actively identifying opportunities to reduce the burden on the medical device industry. In response to the concern that some manufacturers will face audit scheduling challenges in 2018 and may not be issued MDSAP certificates by the deadline, Health Canada has made the following adjustment for manufacturers transitioning to the MDSAP though the surveillance audit process if they meet the following criteria:
This adjustment allows manufacturers to maintain their existing certification cycles. Although manufacturers who transition during the surveillance audit will not receive their MDSAP certificate in 2018, this option provides the manufacturer with the ability to continue selling their devices until they receive the certificate.
In another recent development, Health Canada has announced that small-sized manufacturers could benefit from additional reductions in audit duration provided that they meet the following criteria:
· Have ≤ 100 employees
· Make only lower risk products (e.g. Class II)
· 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 duration calculations procedures have been provided to auditing organizations to apply adjustments as appropriate.
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References:
1. Notice: Adjustments to Medical Device Single Audit Program (MDSAP) Transition (April 13, 2018) https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program/certification-cycle-notice.htm
2. Notice: Medical Device Single Audit Program (MDSAP) Reduction of Audit Time (May 4, 2018) https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/single-audit-program-reduction-audit-times.html