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Medical Device Single Audit (MDSAP)

Medical  Device Single Audit (MDSAP)

Standardizing how we audit medical devices on a global scale.

DEKRA MDSAP

Based on ISO 13485, the Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions. Led by a group of Regulatory Authorities (RA) worldwide, the initiative is aimed at boosting efficiency and safety through increased consistency. As an independent and recognised auditing organisation, DEKRA offers certification to MDSAP.

Participating countries

Australia: The Therapeutics Goods Administration (TGA) will use an MDSAP audit report as part of the evidence in evaluating compliance with the Australian Conformity Assessment procedure

Brazil: The Brazilian National Health Surveillance Agency (ANVISA) will utilise the outcomes of the program, including the reports, to constitute important input into ANVISA’s pre-market and post-market assessment

Canada: HC will use an MDSAP audit and associated MDSAP certification to support medical device licensing for manufacturers intending to sell medical devices in Canada

USA: The USA’s Food and Drug Administration (FDA) will accept the MDSAP audit reports as a substitute for FDA routine inspections

Japan: Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) will use the MDSAP audit report to, e.g., exempt from inspections and substitute documents

How can we help you with Auditing Medical Devices?

At DEKRA, we perform MDSAP audits and keep our customers up to date about relevant developments concerning the program.

For more details on the MDSAP programme or to reach out to one of our experts for more information please click here

Contact

DEKRA Certification UK Limited 

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+44 330 9120 368
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