The initial pilot phase of the MDSAP, designed to confirm the proof-of-concept, was launched on January 1, 2014.
Participating Regulatory Authorities (RA) include the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), and the U.S. Food and Drug Administration (FDA). All RAs participating in the MDSAP Pilot are equal partners in the program. The MDSAP Pilot enables medical device manufacturers to get an
early start on having an authorized Auditing Organization (AO) under the MDSAP Pilot conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the RAs participating in the pilot program. As a result, MDSAP Pilot audit reports may be used by RAs participating in the MDSAP Pilot in lieu of their own inspection reports.
