Munich. TÜV SÜD America is one of the first auditing organizations (certification bodies) to become authorized 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 recognized by several countries. TÜV SÜD started to carry out audits under the MDSAP program 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, Japan 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 program.
Successful integration of country-specific requirements
The MDSAP was initiated in 2012.. The FDA is the current Chair of the MDSAP RAC. Participants in the program are the regulatory authorities of Australia, Brazil, Japan, the USA and Canada, with 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 program'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 program. 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 the Medical Device Single Audit Program (MDSAP) and how TÜV SÜD America can assist, visit http://www.tuv-sud-america.com/healthcare-medical-devices.
Vice President, Quality & Regulatory Affairs
TÜV SÜD America Inc.
Royth von Hahn
U.S. Director, Active Medical Devices Auditing & Testing
TÜV SÜD America Inc.