Medical Device Single Audit Program (MDSAP)
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 various Regulatory Authorities (RA) worldwide, the initiative is aimed at boosting efficiency and safety through increased consistency. Currently, the following countries participate in the program: Australia, Brazil, Canada, Japan and the USA. At DEKRA, we perform MDSAP audits and keep our customers up to date about relevant developments concerning the program. Sharing knowledge is all part of our service.
As an independent and recognized auditing organization, DEKRA performs audits within the MDSAP. Our experts have extensive knowledge of and experience with MDSAP and the requirements of the Regulatory Authorities that participate in the program: TGA in Australia, ANVISA in Brazil, Health Canada, MHLW and PMDA in Japan, and FDA in the USA.