Medical Device Single Audit Program (MDSAP)

General

Medical device manufacturer (MDM) who wished to sell, distribute or license their products in Australia, Brazil, Canada, Japan, and USA had to demonstrate fulfilment of the national regulatory requirements of each respective country within different approval processes. This naturally involved a great deal of time and expense. IMDRF (International Medical Devices Regulators Forum) developed and recognizes a unified program – the MDSAP (Medical Device Single Audit Program) – which covers different regulatory requirements. Conformity with the relevant requirements of the regulatory authorities can now be demonstrated by manufacturers within the framework of one single audit.

Objectives of the MDSAP

The objective of the MDSAP is to achieve a common and global approach to auditing and monitoring the manufacturing of medical devices by taking different regulatory requirements into consideration. The national rules were retained and medical device manufacturers were required to demonstrate compliance to the relevant requirements of the regulatory authorities participating in MDSAP and must have their quality management system monitored by a third party MDSAP recognized auditing organization (AO).

About IMDRF

International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world was established in October 2011 with a purpose to promote international harmonization and convergence of different countries regulations in the field of medical devices.

Recognition of the MDSAP within the regulatory frameworks

Australia TGA uses the MDSAP audit reports and certificates for making regulatory decisions (granting Marketing Authorization or postponing on-site TGA audit), primarily for those medical device manufacturers who do not hold EU Certification. However, certain conformity assessments must be presented within the framework of the market approval.

Brazil ANVISA accepts MDSAP audit reports for Brazilian GMP Certification purposes, provided the Brazilian specific requirements are covered. Brazil requires a GMP Certificate from ANVISA for registration of medical devices of Classes III and IV. The GMP Certificate can be issued based on an ANVISA inspection or the MDSAP audit report issued by a recognized MDSAP auditing organization.

Health Canada recognizes and accepts the MDSAP certificate to grant product licenses to sell products in Canada. MDSAP certification is required to obtain a project licence with Health Canada.

Japan PMDA and MHLW accepts the MDSAP audit report and when a MDSAP audit report is submitted, then PMDA may perform off-site inspection instead of on-site inspection or reduce documents for off-site inspection.

US FDA accepts MDSAP audit reports as a substitute for routine Agency inspections. However, MDM whose activities are related to the Electronic Product Radiation Control (EPRC) provisions of the act was still subjected to FDA and are not included in the MDSAP program.

Recognition required for Auditing Organizations

TUV USA Inc. (member of TÜV NORD Group) has already been recognized as the auditing organizations (AOs) by the Regulatory Authorities and is able to conduct audits within the framework of the MDSAP Program.

International growth of the program

More and more regulatory authorities and international medical device manufacturers have started to accept and join the MDSAP program. Since the inception of the MDSAP program, regulatory authorities who are interested in the MDSAP program must join the program as official observers or as affiliate members. More information could be obtained from FDA website.

Regulatory authorities participating in the MDSAP include: 

MDSAP members:

• 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)

MDSAP official observers:

• European Union (EU)
• Singapore’s Health Sciences Authority (HSA)
• United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
• The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme

MDSAP affiliate members:

• Argentina’s National Administration of Drugs, Foods, and Medical Devices (ANMAT)
• Ministry of Health of Israel
• Kenya’s Pharmacy and Poisons Board
• Republic of Korea’s Ministry of Food and Drug Safety
• Federal commission for Protection from Sanitary Risks (COFEPRIS) of Mexico
• South African Health Products Regulatory Authority (SAHPRA)
• Taiwan Food and Drug Administration (TFDA)