Medical Device Single Check (MDSAP)

The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that are accepted in multiple regulatory jurisdictions. The initiative, led by various Regulatory Authorities (RAs) around the world, aims to improve efficiency and safety through increased consistency. As an independent and recognized auditing organization EUROLABcarries out inspections within MDSAP.

EUROLAB Inspecting Medical Devices 

Australia: The Therapeutic Products Administration (TGA) will use an MDSAP audit report as part of the evidence to assess compliance with the Australian Conformity Assessment procedure.
Brazil: The National Health Surveillance Agency of Brazil (ANVISA) will use the results of the program, including reports, to form important input to ANVISA's pre-market and post-market evaluation.
Canada: HC will use an MDSAP audit and corresponding MDSAP certification to support medical device licensing by manufacturers wishing to sell medical devices in Canada
USA: US Food and Drug Administration (FDA) to accept MDSAP inspection reports instead of FDA routine inspections
Japan: The Ministry of Health, Labor and Welfare (MHLW) and the Medicines and Medical Devices Agency (PMDA) of Japan will use the MDSAP audit report, for example, to exempt inspections and substitution certificates.

How can we help you with Inspecting Medical Devices?

The following countries are currently participating in the program: Australia, Brazil, Canada, Japan and the USA. EUROLABWe conduct MDSAP audits in , and keep our customers informed of developments regarding the program. Our experts have extensive knowledge and experience of MDSAP and the requirements of participating Regulatory Authorities: TGA in Australia, ANVISA in Brazil, Health Canada in Japan, MHLW and PMDA in Japan, and FDA in the USA. If you are looking for more (technical) details, continue reading the more specific pages about Medical Device Single Audit Program services or you can reach out to one of our experts for more information.

EUROLAB, with its highly expert team and internationally accredited laboratories, Medical Device Single Check (MDSAP) It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.