Medical Device Single Audit Program (MDSAP)

One audit for five markets – Australia, Brazil, Canada, Japan and USA
New Affiliate Members: Argentina and Republic of Korea

In the past, medical device manufacturers who wished to license their products in Australia, Brazil, Canada, Japan and USA had to demonstrate fulfilment of the national regulatory requirements of each country within different approval processes. This naturally involved a great deal of time and expense. The MDSAP was developed by the IMDRF (International Medical Devices Regulators Forum) to help international organization bridge the requirements of the international market.

The objective of the MDSAP is to achieve a common audit standard which takes the different regulatory requirements of national approval bodies into consideration. The national rules will retain their validity, which means that medical device manufacturers must have their quality management system audited as part of an ongoing surveillance program by a third party auditing organization recognized or authorized to perform MDSAP audits.

The following Regulatory Authorities are participating in the MDSAP:

• Australia, Therapeutic Goods Administration (TGA),
• Brazil, National Health Surveillance Agency (ANVISA)
• Canada, Health Canada (HC)
• Japan, Pharmaceuticals and Medical Devices Agency (PMDA)
• USA, Food and Drug Administration (FDA)

Argentine’s National Administration of Drugs, Food and Medical Devices (ANMAT) and the Republic of Korea’s Ministry of Food and Drug Safety (MFDS) have signed on as Affiliate Members to MDSAP. The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are official observers of the MDSAP.

Australia TGA recognizes the audit report from the MDSAP audit. However, certain conformity assessments have to be presented within the framework of the market approval.

Brazil ANVISA recognizes MDSAP in place of the initial audit. Brazil requires a GMP certificate from ANVISA for the registration of medical devices for Class II and IV devices. The GMP certificate can be based on an ANVISA audit or the audit report of a recognized MDSAP auditing organization.

Health Canada recognizes the MDSAP certificate to grant product licenses. The MDSAP program has fully replaced the CMDCAS program.

Japan PMDA and their Health Ministry have fully accepted the MDSAP audit report in lieu of its inspection.

The US FDA recognizes MDSAP audits in place of routine inspections. The FDA will continue to inspect manufacturers with activities in relation to Electronic Product Radiation Control (EPRC).