Medical Device Single Audit Program (MDSAP) Training Course

The Introduction to the Medical Device Single Audit Program (MDSAP) Training Course provides a foundational understanding of the MDSAP framework, its objectives, and its impact on the medical device industry. This course is designed for professionals who are new to MDSAP and wish to gain insights into how the program works, its key requirements, and how it integrates with existing regulatory frameworks such as ISO 13485:2016.

The MDSAP program allows a single regulatory audit to satisfy the requirements of multiple participating countries, including the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA), and Australia (TGA). This introductory course will help participants understand the fundamentals of MDSAP and how it applies to medical device manufacturers. Please note that this course provides a comprehensive introduction to MDSAP; however, internal auditors are required to complete the MDSAP Internal Audit Course for full competency in conducting internal audits.

The Medical Device Single Audit Program (MDSAP) is an initiative developed by the International Medical Device Regulators Forum (IMDRF) to allow a single audit to meet the regulatory requirements of multiple countries. The following five regulatory authorities participate in MDSAP:

1. United States – U.S. Food and Drug Administration (FDA)

   • Recognizes MDSAP audit reports as a substitute for routine FDA inspections (except for pre-approval and for-cause inspections).

2. Canada – Health Canada (HC)

   • Requires MDSAP certification for manufacturers seeking to market their devices in Canada, replacing the former Canadian Medical Device Conformity Assessment System (CMDCAS).

3. Brazil – Agência Nacional de Vigilância Sanitária (ANVISA)

   • Uses MDSAP audit reports as part of the pre-market approval and post-market surveillance processes.

   • MDSAP does not replace ANVISA’s on-site inspections but may reduce their frequency.

4. Japan – Pharmaceuticals and Medical Devices Agency (PMDA) & Ministry of Health, Labour and Welfare (MHLW)

   • Uses MDSAP audit reports in pre-market and post-market regulatory processes to support Japan’s medical device regulations.

5. Australia – Therapeutic Goods Administration (TGA)

   • Accepts MDSAP audit reports as evidence of compliance with Australian medical device regulations, reducing the need for additional audits.

The MDSAP Audit Model

The MDSAP Audit Model is structured around a process-based approach, integrating ISO 13485:2016 with country-specific regulatory requirements. It consists of seven key processes that auditors follow during an MDSAP audit