Medical Device Single Audit Program (MDSAP)

One audit for multiple market access

One audit for multiple market access

 

MEDICAL DEVICE SINGLE AUDIT PROGRAM - MDSAP


Medical device manufacturers are faced with increased product development costs and time-to-market challenges as they must apply for testing and certification with different Certification Bodies to gain access to individual export markets. A globally consistent approach to the auditing and monitoring of medical device manufacturing is needed to minimise burdens and eliminate redundancy, while improving safety and efficacy.

MDSAP promotes the greater alignment of regulatory approaches and technical requirements while simultaneously encouraging consistency and transparency within regulatory programs. The idea is that MDSAP will manage and oversee a single audit program that will allow a single regulatory audit to satisfy the varying requirements in multiple jurisdictions. 

TÜV SÜD is an authorised auditing organisation, which can support any medical device manufacturer that sells into at least one of the participating MDSAP markets, regardless of their current Certification Body. Download the infosheet to learn more.

Download the MDSAP infosheet

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