TÜV SÜD America is one of the first Auditing Organizations (AO) which, beginning July 2014, has been authorized by the MDSAP Regulatory Authority Council (RAC) Pilot Consortium to carry out audits within the MDSAP pilot program. The Medical Device Single Audit Program (MDSAP) is a project of the IMDRF. Its goal is to develop common standards for quality management audits, which will be recognized by multiple participating countries. In the future, quality management system requirements for Medical Device manufacturers according to the regulations of Canada, Australia, Brazil and the USA will be satisfied by one single audit and the approval process might be considerably expedited e.g. in Brazil. TÜV SÜD plans to carry out its first MDSAP audits in October 2014.
One audit for four markets
Georg Bauer, Department Manager Foreign Affairs at TÜV SÜD Product Service in Munich, considers this to be a very attractive program for manufacturers. In his opinion, “it brings the biggest advantages to manufacturers serving the United States and Brazil." The Food and Drug Administration of the USA (FDA) recognizes MDSAP audits in lieu of routine inspections. Exceptions are initial inspections, inspections within the scope of a Pre-Market Approval project (PMA) for high risk products in risk class III and inspections “for cause."
The Brazilian Agência National de Vigilância Sanitária (ANVISA) accepts MDSAP for initial audits. In Brazil class III and IV device applications need a GMP certificate issued by ANVISA. ANVISA can issue a GMP certificate based on their audit or a MDSAP Auditing Organization (AO) audit report. An audit by ANVISA, with the corresponding waiting period of several years from the time of the manufacturer’s application, is no longer necessary. The approval process is substantially expedited in this case.
The Therapeutic Goods Administration (TGA) in Australia accepts the audit reports of the MDSAP program, with certain exemptions, as part of the evidence required for compliance for market authorization.
Japan’s Pharmaceutical and Food Safety Bureau and Ministry of Health, Labour and Welfare take part in MDSAP as observers. European participation in the program is not planned at the moment. “However, we offer our clients the possibility of combining audits according to the European Medical Device Directive (MDD) with the MDSAP audits,” says Bauer. This option is already available in the pilot phase.
Successful integration of country-specific regulations
The MDSAP is one of several projects of the IMDRF, initiated in 2012 and coordinated by Kim Trautman, Associate Director for International Affairs in the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) the current Chair of the MDSAP RAC. In addition to the participants, namely, the regulators for Australia, Brazil, the USA and Canada, the management committee also includes representatives from Japan, China, the European Commission and Russia. The MDSAP is based on ISO 13485 and, additionally, includes the country-specific requirements of the participants′ regulations which go further than the ISO 13485 requirements. No country-specific rules and regulations are changed by the MDSAP. The pilot phase began in January 2014 and runs until the end of 2016.
For manufacturers MDSAP can lead to a considerable competitive advantage. If you want to take advantage as one of the first manufacturers, from now on you can incorporate MDSAP into your next audit. Georg Bauer is available to answer your specific questions on MDSAP.
Stuck with your class III and IV registration in Brazil? Waiting for ANVISA's audit?