Medical Device Single Audit Program Reduction of Audit Times for small-sized enterprises – updatePublished on June 12, 2018
Author: Bhavesh Patel, C. Chem.
Health Canada is continuing to work towards the target date of January 1, 2019 to transition to MDSAP Quality Management System certificates being accepted for medical device licence applications. Based on the comments received from industry, Health Canada has continued to work in collaboration with the MDSAP Consortium to identify additional opportunities for audit duration reductions. This reduction time is aligned 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 utilizing commonly available materials and established technologies;
· Have a good history of conformity to ISO 13485 and regulatory requirementsUpdated 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 are effective as of June 11, 2018
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