Industry Feedback Brings MDSAP Changes

Overview:

The Medical Device Single Audit Program (MDSAP) offers medical device manufacturers a mechanism to streamline audits required by regulatory authorities around the world. Under MDSAP, a single audit performed by an authorized Auditing Organization (AO) is deemed sufficient to assess compliance with the quality management system requirements of regulatory agencies in multiple medical device markets: United States, Canada, Japan, Brazil and Australia.

Beginning January 1, 2019, companies marketing Class II, III and IV devices in Canada will need a valid MDSAP certificate to obtain, maintain or amend a medical device license. Medical device companies that have not transitioned from their Canadian Medical Device Conformity Assessment System (CMDCAS) certificates to MDSAP ones will face device license suspension. Despite some concerns from industry, Health Canada still intends on sticking to the 2019 deadline.

Changes to MDSAP:

Due to response of industry feedback to Health Canada, audit timeframes have been reduced. The audit time reductions will primarily target smaller medical device companies with fewer resources to devote to regulatory compliance.

Over the last couple months, Canadian Medical Device License Holders provided feedback regarding the current audit time model for MDSAP and subsequent annual surveillance audits. Based on this feedback, Health Canada 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.

Health Canada also states that the MDSAP Consortium has additional plans to improve efficiency and reduce audit times; these changes will be announced in the near future.

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 license applications.

Does your company need help preparing for MDSAP?

The AlvaMed team can: determine whether MDSAP is right for you, transition your QMS to align with MDSAP and perform mock audits to prepare your company for MDSAP. Please do not hesitate to reach out: info@alvamed.com or 888 – 33 – 13485. For further information on the MDSAP program.