One audit for five markets
In the past, medical device manufacturers that wanted to licence their products in Australia, Brazil, Canada, Japan and the USA needed to demonstrate in different approval processes that they fulfilled the national regulatory requirements of each country. This was of course very costly and time-consuming. Now the IMDRF (International Medical Devices Regulators Forum) has developed a new, standardised programme - the MDSAP (Medical Device Single Audit Program) - which covers different regulatory requirements. Conformity with these requirements can now be demonstrated by manufacturers within the framework of a single Audit.
The aim of the MDSAP is to develop a joint certification standard, which takes into consideration the different regulatory requirements of the national approval authorities. The national regulations retain their validity, i.e. the manufacturers of medical devices need to have their quality management system monitored once per year in a surveillance audit by an external testing organisation that has been approved for the MDSAP.
The International Medical Device Regulators Forum (IMDRF) was founded in February 2011 in order to discuss the future orientation of regulatory harmonisation in the field of medical technology. The Forum consists of voluntary groups of medical supervisory authorities from all over the world, and aims to accelerate the harmonisation and convergence of regulations in the international medical industry.
Regulatory authorities participating in the MDSAP pilot programme
- 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)
Recognition within the framework of the MDSAP programme
The American FDA recognises MDSAP audits as a proxy for routine inspections. Initial inspections are not covered by the recognition.
ANVISA recognises MDSAP audits as initial audits. For the registration of medical devices in classes III and IV, Brazil fundamentally requires a GMP certificate from ANVISA. The GMP certificate can be issued on the basis of an ANVISA audit, or the audit report of a recognised MDSAP audit organisation.
TGA Australia recognises the audit reports from the MDSAP audit. Certain conformity assessments must however be presented as part of the market approval.
Health Canada recognises the MDSAP certificate in order to issue product licences for the sale of products in Canada.
The Japanese approval authority PMDA and also the Ministry of Health have announced that they will officially join the MDSAP programme and will accept the MDSAP audit report. Registration process for certification bodies
TUV USA Inc. (member of the TÜV NORD Group) already became one of the first testing organisations to be registered by the supervisory authorities, and is entitled to perform audits within the framework of the MDSAP pilot programme.