Tokyo, Japan - TÜV SÜD Japan Ltd. is now expanded the scope of marketing certification services for designated Specially Controlled Medical Devices (Class III medical devices). The company is now capable to conduct marketing certification for following Class III Medical Devices designated by the Minister of Health, Labour and Welfare (MHLW).
TÜV SÜD Japan is now permitted to evaluate Class III “me-too” medical devices and issue marketing certificates for the following product categories:
<Certification criteria, for which TÜV SÜD Japan certifies, from 25 Nov. 2014>
- Insulin pen injector
- Filter, blood, cardiopulmonary bypass, heparin-coated
and heart-lung bypass system module, defoamer, single use, heparin-coated
< Certification criteria, for which TÜV SÜD Japan certifies, from 25 Mar. 2015>
- Infusion pump, enteral feeding / Infusion pump, general-purpose / Infusion pump, syringe and Infusion pump, analgesic, patient-controlled
<Addedcertification criteria, for which TÜV SÜD Japan certifies, from September 30, 2015>
- Resuscitator, pulmonary, manual, reusable / Resuscitator, pulmonary, manual, single use
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.