The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to undergo a single regulatory audit that covers the requirements of several jurisdictions instead of undergoing several audits. This program satisfies all pertinent regulatory parties for medical device companies and encompasses a standardized, global approach to auditing with a focus on reducing the regulatory burden faced by the medical device industry.
Here are 5 things you need to know about MDSAP:
- The audit program associated with MDSAP does not add any new requirements. Instead it incorporates the existing requirements of ISO 13485:2016 as well as specific requirements related to the participating countries and their respective regulatory agencies. To date, the geographies participating in the program include:
- The U.S. (FDA)
- Canada (Health Canada)
- Brazil (ANVISA)
- Australia (Therapeutics Goods Administration)
- Japan (Ministry of Health, Labor, and Welfare)
A manufacturer is expected to comply only with the requirements related to those jurisdictions where it markets its products.
- Medical device manufacturers should not engage with a particular regulatory authority to participate in MDSAP. Instead, you should directly contact an approved Auditing Organization (AO).
- MDSAP includes a single annual assessment of an organization’s quality management system. Full, formal certification will be available every 3 years.
- If an AO issues a negative audit report, that does not necessarily mean the manufacturer has to stop selling in all of the relevant jurisdictions. Each individual regulatory agency will determine the appropriate actions based on the auditor's findings.
- Upon successful completion of an MDSAP audit, the AO will issue written certification to the medical device manufacturer that specifically documents compliance with the requirements of ISO 13485 as well as with any other regulations pertaining to the applicable jurisdictions.