Medical Device Single Audit Program

by | Apr 6, 2022 | Compliance, Consulting Group, FDA, MDSAP, QMS, Quality, Quality Systems, Regulatory, Standardization, Standards

In 2016 the Medical Device Single Audit Program (MDSAP) was initiated. Having a global approach to monitoring and auditing the manufacturing of medical devices improves the safety of devices on an international level. The MDSAP is a recognized known auditing model which conducts regulatory audits of medical device manufacturers that satisfies the regulatory requirements of all participating authorities. The international partners of the MDSAP include:

  • Health Canada
  • Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
  • U.S. Food and Drug Administration (FDA)
  • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
  • Therapeutic Goods Administration of Australia1

There are also MDSAP Observers (EU, WHO, and MHRA) and affiliate members including Singapore, Korea, and Argentina. The MDSAP pilot program ran for 3 years until the MDSAP Regulatory Authority Council identified that MDSAP demonstrated satisfactory viability overall. The FDA has begun accepting MDSAP audit reports as a substitute for routine agency inspections.

Manufacturers following the MDSAP have limited the number of audits conducted overall, resulting in fewer business disruptions. The MDSAP is used for both pre-market and post-market devices, the MDSAP provides evidence that the manufacturer meets the Quality Management System requirements. EMMA International’s team of experts is available to assist with MDSAP auditing preparations, gap assessment, and any other regulatory or quality needs of your company. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.

[1] FDA (February 2022) Medical Device Single Audit Program, Retrieved 04/03/2022 from https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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