MDSAP AUDIT APPROACH UPDATED. Revision Date: 2024-08-06.

The design of the Medical Device Single Audit Program (MDSAP) audit process is to ensure a single audit will provide efficient yet thorough coverage of regulatory requirements. 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 665/2022), the Canadian Medical Devices Regulations, 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.