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MDSAP: Medical Device Single Audit Program

What Is It?


The Medical Device Single Audit Program (MDSAP) is a global approach to auditing and monitoring the manufacturing and safety of medical devices on an international scale. It allows a recognised Auditing Organisation to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.


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, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency

  • U.S. Food and Drug Administration


MDSAP Official Observers:

  • European Union (EU)

  • United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)

  • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme


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

  • Singapore's Health Sciences Authority (HSA)

What Does It Do?

The routines of the MDSAP audit is organised with confirmed standards among the participating authorities. By completing a single audit under the MDSAP, the product compliance of your medical device is recognised by multiple participating regulatory authorities. This program reduces the overall number of audits or inspections for medical device manufacturers.


The program also enhances the confidence of your product reliability for any other third party audit and provides useful information about your product compliance. The outcome of the MDSAP audit helps to achieve efficiency and save time for auditing activities.


By enrolling in the MDSAP, you demonstrate your commitment as a medical device manufacturer to quality management systems for product quality and regulatory compliance.


Why Choose Us?


Wiselink Medical is committed to provide reliable consultancy and efficient services with exceptional knowledge, experience and expertise. We have an international team with a pool of experts from Australia, United States, Canada, Europe and China, who have more than 20 years of industry knowledge to offer you the most efficient and cost-effective solutions.

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