Munich - TÜV SÜD America is one of the first auditing organisations (certification bodies) to become authorised by the MDSAP Regulatory Authority Council (RAC) Pilot Consortium to carry out audits within the MDSAP pilot project.The Medical Device Single Audit Program (MDSAP) is designed to develop a standard for quality management audits at the manufacturers of medical devices that is mutually recognised by several countries.TÜV SÜD started to carry out audits under the MDSAP programme in October 2014.
Under the Medical Device Single Audit Program, all requirements for the quality management systems of the manufacturers of medical devices and other particular country specific requirements according to the regulations applicable in Canada, Australia, Brazil and the USA can be assessed in a single audit in the future. This may significantly speed up the registration process for medical-device manufacturers in general as well as their registration processes in the individual countries participating in the MDSAP, such as Brazil. They can start to benefit from the offered advantages as early as the pilot phase of the programme.
Successful integration of country-specific requirements
The MDSAP was initiated in 2012 and is 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. Participants in the programme are the regulatory authorities of Australia, Brazil, the USA and Canada, with Japan and WHO as observers. Discussions are ongoing for the EU Commission to also be observers to the Pilot Consortium. The MDSAP is based on the international standard ISO 13485 "Medical devices – Quality management systems – Requirements for regulatory purposes" and also takes into account all national regulatory requirements of the participating countries that go beyond the requirements of the ISO 13485 standard. In addition, other particular country requirements are also assessed such as registration, licensing, recalls, vigilance reports, etc. The MDSAP will cause no changes in the national regulations. The programme's pilot phase started in January 2014 and will run for three years up to the end of 2016.
Benefits for manufacturers in Brazil and the USA
"The MDSAP particularly benefits manufacturers that export their medical devices to the United States and Brazil", says Georg Bauer, Department Manager Foreign Affairs at TÜV SÜD Product Service GmbH in Munich. The US Food and Drug Administration (FDA) already accepts MDSAP audits instead of routine inspections. Inspections for pre-market approval projects of class III high-risk devices and inspections conducted "for cause" are excluded from the programme. Brazil's ANVISA (Agência Nacional de Vigilância Sanitária) also accepts MDSAP audits for certain initial and surveillance audits. Manufacturers require a BGMP certificate for the registration of class III and IV medical devices, which is issued by ANVISA following successful completion of a BGMP audit. Participation in the MDSAP pilot project can considerably speed up the registration of medical devices as audits need no longer be carried out by ANVISA, so that the waiting periods of up to several years following application by the manufacturer can possibly be avoided.
More information about TÜV SÜD's services in the field of medical devices can be found on the Internet at www.tuev-sued.de/mhs. You can also find TÜV SÜD's experts for medical devices at Medica, which will take place in Duesseldorf from 12 to 15 November 2014 (Hall 10, Stand C12). The key topics at TÜV SÜD's stand (Hall 10, Stand C12) will range from the Medical Device Single Audit Program (MDSAP) to unannounced audits at the manufacturers of medical devices and changes in the registration procedures in Japan and China.