The MDSAP provides efficient yet thorough coverage of multiple medical devices auditing requirements, including:
- ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes
- RDC ANVISA 16/2013 – Brazilian Good Manufacturing Practices
- MHLW Ministerial Ordinance No. 169 – Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents
- 21 CFR 820 – U.S. Quality Management System Regulation
MDSAP-recognized Auditing Organizations (AOs) can conduct a single audit of a medical device manufacturer that satisfy the relevant requirements of the medical device regulatory authorities participating in the program. The participants include Australia’s Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada (HC), Japan’s Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency (MHLW and PMDA) and the United States Food and Drug Administration (FDA).