Japan PMDA, List of Third-Party Registered Certification Bodies (RCBs)

PMDA (Pharmaceutical and Medical Device Agency) is a comprehensive pharmaceutical and medical device organization that aims to contribute to improving national health by guiding and examining the quality, efficacy, and safety of pharmaceuticals and medical devices, and collecting, analyzing, and providing information on safety after marketing.

 

Japan's medical device classification system is based on the Japanese Medical Device Nominality Code, and Japan's medical devices are classified into four classes, Class I to Class IV. The classification of a medical device is determined by considering the characteristics, purpose of use, and method of use of the product based on the risk of the product.

 

Some Class II and Class III designated managed medical devices require certification from a third-party registered certification body (RCB) registered by the PMDA.

The third-party registration certification body (RCB) registered under Article 23-6, Paragraph 1 of the Act on Securing Quality, Effectiveness and Safety of Medical Devices, etc. is as follows.

 

1) TÜV SÜD Japan Co., Ltd. (テュフズードジャパン株式会社)

2) TÜV Rheinland Japan K.K. (テュフ・ラインランド・ジャパン株式会社)

3) German Quality System Certification Company (ドイツ品質システム認証株式会社)

4) BSI Group Japan K.K. (BSI グループジャパン株式会社)

5) SGS Japan K.K. (SGS ジャパン株式会社)

6) Cosmos Corporation (株式会社コスモス・コーポレイション)

7) Japan Quality Assurance Organization (一般財団法人日本品質保証機構)

8) Nanotech Spindrer Co., Ltd. (ナノテックシュピンドラー株式会社)

9) Electrical Safety and Environmental Research Laboratory (一般財団法人電気安全環境研究所)

10) Medical Device Center (公益財団法人医療機器センター)

 

A total of 7 of the existing registered certification bodies have been abolished, and there are currently a total of 10 third-party registered certification bodies (RCBs) as above.

Please refer to the work.

 

For more information, please refer to the link below.

https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/touroku/index.html

登録認証機関制度について

 

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