The Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) is a relatively new initiative launched by the International Medical Device Regulators Forum. Originating from the Global Harmonization Task Force, this program aims to streamline the process for obtaining Quality Management System (QMS) certifications for international companies.

This is image about MDSAP.

The primary objectives of MDSAP are to:
    1.   Eliminate the duplication of regulatory efforts across multiple countries.
    2.   Minimize disruptions to medical device manufacturers by consolidating regulatory audits.

MDSAP audits are conducted by Auditing Organizations (AOs), which are private companies that meet specific MDSAP requirements. Manufacturers hire these AOs to perform MDSAP audits, and many of these organizations can also conduct ISO 13485 audits concurrently.

Currently, five countries actively participate in MDSAP. While it is a single audit program, each country imposes market-specific requirements:
    •   United States: FDA 21 CFR 820
    •   Australia: TGA
    •   Brazil: ANVISA RDC 665
    •   Canada: CMDR
    •   Japan: MHLW Ministerial Ordinance No. 169

Canada uniquely mandates MDSAP certification for selling in its market, driving many multinational manufacturers to seek certification. In the United States, MDSAP certification can exempt manufacturers from routine FDA inspections unless issues arise.

The MDSAP audit process includes seven key elements:

    1.   Management
    2.   Device marketing authorization and facility registration
    3.   Measurement, analysis, and improvement
    4.   Medical device adverse events and advisory notices reporting
    5.   Design and development
    6.   Production and service controls
    7.   Purchasing

Manufacturers benefit from participating in MDSAP primarily by saving time and resources. Consolidating multiple audits into a single process reduces the preparation, response, and remediation efforts typically required for each audit, allowing manufacturers to focus on other priorities. Additionally, there are cost savings associated with undergoing a single audit instead of multiple ones.