On October of 2020, The Medical Device Single Audit Program (MDSAP) has published a new consolidated guidance document called,  MDSAP AU P0002.005 Audit Approach. The revision combines the former MDSAP Audit Model and Process Companion Document​ into a single document of information detailing the auditing process for the quality management systems (QMS) of medical device manufacturers.


The MDSAP Council has added annexes providing further guidance on assessing conformity for each audited process. The annex gives deadlines for submitting adverse events reports and advisory notices; requirements for written agreements between manufacturers and suppliers. The annexes reference key clauses from international  quality management standard of ISO 13485:2016.

Annex 1- Audit of Product/Process related Technologies and Technical Documentation

  • Annex 1 contains country specific information as to the expectations for the audit of product / process related technologies (other than sterilization – See Annex 2) and the audit of technical documentation as part of the execution of the Audit Tasks.

Annex 2Audit of Requirements for Sterile Medical Devices

  • Annex 2 contains information as to the expectation for the audit of requirements for sterile medical devices.

Annex 3 – Medical Device Adverse Events and Advisory Notices Reporting Process Quick Reference

  • Annex 3 contains a table showing a summary of timeframes for reporting advisory notices and individual adverse event reports in the participating MDSAP jurisdictions.

Annex 4 – Requirements for Written Agreements

  • Annex 4 contains Australian country specific guidance on expectations for various types of written agreements for regulatory purposes. 

Regulatory Corner:

International partners that are participating in the MDSAP include:

  • MDSAP Members
    • Therapeutic Goods Administration of Australia
    • Brazil’s Agência Nacional de Vigilância Sanitária
    • Health Canada
    • Japan’s Ministry of Health, Labor and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
    • U.S. Food and Drug Administration
  • MDSAP Official Observers:
    • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program
    • European Union (EU)
  • MDSAP Affiliate Members: (New)
    • Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
    • Republic of Korea’s Ministry of Food and Drug Safety

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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