MDSAP Changes Aim to Reduce Audit Times
With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits.
The changes follow comments received by Health Canada from Canadian medical device license 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, according to Health Canada:
- “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.”
The changes come as the transition to the MDSAP, initiated by the International Medical Devices Regulators Forum, was first proposed by Health Canada in December 2015.
Health Canada added that other mechanisms to improve efficiency and reduce audit times are also being explored and will be announced in the near future.