Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is a global initiative intended to accelerate medical device regulatory harmonization by allowing a single regulatory audit to satisfy the requirements of multiple jurisdictions. The MDSAP intends to allow competent auditors from MDSAP-recognized Auditing Organizations (AOs) to conduct a single audit of a medical device organization’s quality management system that will satisfy the requirements of the medical device regulatory authorities participating in the MDSAP program.

These requirements include; Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016), the Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Japanese Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169), the Quality System Regulation (21 CFR Part 820), and specific requirements of the medical device regulatory authorities participating in the MDSAP program.