Overcoming the Challenge of Achieving Compliance in Multiple Markets
The Medical Device Single Audit Program is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory compliance of up to five different medical device markets in lieu of the current market specific regulations. The inconsistency in country specific regulations means multiple audits and requirements, leading to increased compliance costs, time and resources, which can be an impediment to expanding into new markets. MDSAP was developed to overcome these challenges and to create new opportunities for manufacturers looking to expand as well as harmonize regulations. Coordination between participating countries has encouraged consistency and transparency within their regulatory programs.
MDSAPs audits are conducted by Authorized Organizations (AOs). The single GMP audit on medical device manufacturing facilities and will stand to support registrations across the current participating member countries: The United States, Canada, Brazil, Australia and Japan.
A significant change is the handling of non-conformities: the MDSAP non-conformity are based on a Point-Based Nonconformity Grading System. Non-conformities are typically graded on a scale of 1 to 5, with a grade of 1, 2, or 3 considered a minor non-conformity, and grades 4 and 5 being considered far more serious.
The benefit, however, of only having to comply with a single program across five countries, outweighs initial challenges of implementation. Currently, only Canada will require the MDSAP. Beginning 1 January 2019, companies marketing Class II, III and IV devices in Canada will need a valid MDSAP certificate to get, maintain or amend a medical device license
•United Sates: MDSAP can be an alternative to an FDA inspection, excluding combination products and PMA inspections. Certification documents issued by the AO must comply with applicable U.S. regulations. Additionally, the FDA will accept MDSAP in lieu of routine inspection, but not for initial visits or “for cause inspections.”
•Canada: Health Canada will use MDSAP to satisfy CMDCAS, and is planning to replace CMDCAS with MDSAP in January 2019. Therefore, medical device manufacturers currently selling in Canada will have to obtain MDSAP certification.
•Brazil: ANVISA will accept MDSAP for initial audits. The agency will still require its auditors to conduct ANVISA audits for higher-risk devices. Brazil allows MDSAP reports to be used as an alternative to an ANVISA inspection, but only when the previous ANVISA inspection was deemed satisfactory.
•Australia: TGA will use MDSAP to satisfy TGA requirements, considering MDSAP certificates as equivalent CE certificates.
•Japan: MHLW will accept MDSAP in lieu of an on-site Japanese Quality Management System (J-QMS) audit. An MDSAP audit report submitted at the time of pre- or postmarket QMS inspection can be used as a trial to exempt some manufacturing sites from on-site inspection, and/or to allow the Manufacturer’s Marketing Authorization Holder (MAH) to substitute the MDSAP report for a considerable part of documents required for the inspection.
Currently Europe is not participating, however, the EU may join the program. MDSAP’s aim to harmonize quality system compliance (ultimately increasing the safety and efficacy of medical devices) should serve as a way for EU to increase quality consistency across its member states.
As globalization continues it is well worth considering participating in MDSAP and if selling in Canada, you will be required to do so.