TÜV SÜD Japan Ltd. is now authorized to provide marketing certification services for designated Specially Controlled Medical Devices (Class III medical devices). The company is one of the only two Registered Certification Bodies (RCB) in the market authorized to conduct marketing certification for Class III Medical Devices designated by the Minister of Health, Labor and Welfare (MHLW). The certification criteria have been specified along with the implementation of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act).
The Pharmaceutical Affairs Law (PAL) was revised on 27 November 2013 while the PMD Act was enforced on 25 November 2014. With the enforcement of the PMD Act, RCBs such as TÜV SÜD Japan are now permitted to evaluate Class III “me-too” medical devices and issue marketing certificates for the following product categories:
- Insulin pen injector
- Filter, blood, cardiopulmonary bypass, heparin-coated
and heart-lung bypass system module, defoamer, single use, heparin-coated
Additionally, Class III medical devices’ certification criteria no longer require compliance with specific JISs. It is expected that around 10% of Class III devices will be subject to certification by RCBs in next one to two years.
TÜV SÜD Japan was the first certification body registered by Japan’s Minister of Health, Labour and Welfare, and is an RCB for all Class II medical devices, Class III medical devices and Class II invitro diagnostic reagents. The company provides various certification services including CE marking (EC certification) for the European market, CMDCAS certification based on the Canadian Medical Device Regulations, and testing and product certification and/or mandatory QMS audit for the Japanese market in addition to the quality management system ISO 13485 certification. TÜV SÜD Japan provides customers with an effective one-stop service from testing to certification, including biological evaluations, electrical testing based on IEC60601-1 (Version 3), and EMC testing.