MDSAP(Medical device single audit program)

International Medical Device Regulators Forum (IMDRF) developed a MDSAP program to conduct regulatory audits of quality management systems (QMS) of manufacturers of medical devices.

MDSAP program covers the below quality management systems requiremenrts.

• Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical  Devices) Regulations (TG(MD)R Sch3)
• Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
• Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)
• Quality System Regulation (21 CFR Part 820)

MD SAP members are listed below,

• Therapeutic Goods Administration of Australia
• Brazil’s Agência Nacional de Vigilância Sanitária
• Health Canada
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
• U.S. Food and Drug Administration

MDSAP audit uses a process approach and built based on a foundation of risk management.MDSAP audit approach is available here.

– Management

– Measurement, Analysis and Improvement

– Design and Development

– Production and Service Controls.

– Purchasing

– Medical Device Adverse Events and Advisory Notices Reporting

– Device Marketing Authorization and Facility Registration.

Audit approach also have links to the applicable regulatory requirements for participating jurisdictions 

Kindly refer the US FDA CDRH Learn- Inspections - Global Harmonization to know more about MDSAP