TÜV SÜD Japan Ltd. is pleased to announce two certifications as to designated Specially Controlled Medical Devices (Class III medical devices) based on PMD Act, those are Insulin pen injectors and categorized into higher risk products than Class II ones. Now, in Japan the scope of marketing certification services for Class III Medical Devices has been expanded.
TÜV SÜD is capable of reviewing Class III Medical Devices designated by the Minister of Health, Labour and Welfare (MHLW), after receiving trainings conducted by the Pharmaceutical and Medical Device Agency (PMDA). TÜV SÜD is offering prompt and high-integrity certification service by expanding experts for both active and non-active Medical Devices field. Please find the table of scopes for Class III Medical Devices here.
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.
Please find further information about TÜV SÜD services for medical and health industry here: http://www.tuv-sud.jp/jp-en/industry/healthcare-medical-devices.
Press-contact: Heidi Atzler