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Medical Device Single Audit Program (MDSAP)

Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is an international initiative developed by a group of medical device regulators, the International Medical Device Regulators Forum (IMDRF) that allows medical device manufacturers to undergo a single regulatory audit for compliance with the quality management system (QMS) requirements of multiple participating regulatory authorities which include 

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

The goal is to streamline the audit process and facilitate market access in different countries.Instead of undergoing separate audits for each regulatory authority, manufacturers can choose to undergo an MDSAP audit, which covers the QMS requirements of all participating authorities.

Benefits of MDSAP for medical device manufacturers

Single Audit for Multiple Authorities:
  • MDSAP allows medical device manufacturers to undergo a single audit that covers the requirements of ISO 13485:2016 (an international standard for quality management systems for medical devices) and the regulatory requirements of participating countries.
Harmonization of Regulatory Requirements:
  • MDSAP contributes to the harmonization of regulatory requirements and expectations among participating countries, making it easier for manufacturers to navigate global markets.
No Ambiguity in requirements:
Cost Savings:
  • Manufacturers can potentially realize cost savings by avoiding the need for multiple audits and related expenses.
Optimum use of resources:
  • The time and effort required and the involvement of Manpower can be greatly reduced with a single audit program rather than having to undergo 5 different audits.
Reduced Regulatory Burden:
  • The harmonization of regulatory requirements under MDSAP reduces the complexity and burden associated with navigating different regulatory frameworks.
Adaptability to Regulatory Changes:

MDSAP can adapt to changes in regulatory requirements, offering a framework that can evolve to accommodate new expectations and standards.