Who makes the final decision on the compliance of the manufacturer?

The AOs are fully responsible for making the decision on conformity to issue MDSAP certification documents under the program. 

Each jurisdiction uses the MDSAP and outputs of the MDSAP in a different way. RAs remain the authority for marketing approval within their jurisdictions. For further information, refer to the jurisdiction specific webpages, linked below:

• Australia’s Therapeutic Goods Administration (TGA)
• Brazilian Health Regulatory Agency (ANVISA)
• Health Canada
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)
• U.S. Food and Drug Administration (FDA).