Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO’s) authorized by the participating Regulatory Authorities to audit under MDSAP requirements.
The MDSAP was developed by representatives of TGA, ANVISA, HC, MHLW/PMDA, and the U.S. FDA.
Benefits of MDSAP
1. Minimize medical device manufacturer disruptions due to multiple regulatory audits
2. Provide predictable audit schedules
3. Benefit patient health and patient access with ease of entry to multiple markets
4. Leverage regulatory resources
5. Incorporate ISO 13485 assessment/requirements
6. Reduction in time, resource dealing and cost of audits with findings from multiple audits
7. Improved transparency in the industry
