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【TÜV SÜD JAPAN INC.】
TÜV SÜD JAPAN, Japan Business Committee Regulatory Cooperation on “Cooperation Memorandum on Medical Device Quality Management System (QMS) Request for Documentation”


【TÜV SÜD JAPAN INC.】
TÜV SÜD JAPAN, Japan Business Committee Regulatory Cooperation on “Cooperation Memorandum on Medical Device Quality Management System (QMS) Request for Documentation”
TÜV SÜD JAPAN CORPORATION TÜV SÜD JAPAN, Nippon Keidanren Regulatory Cooperation on “Cooperation Memorandum on Medical Device Quality Management System (QMS) Request for Documentation” ………………………………………………………………………………… At TÜV SÜD Japan Ltd. (Head office: Shinjuku-ku, Tokyo, President: Dieter Eckhartt), an international third-party certification body, TÜV SÜD, between November 30, 2018 In the memorandum of understanding on cooperation on document request of medical equipment quality control system (QMS) concluded, the QMS compatibility research report issued in Japanese by the PMDA or registered certification body and the standard conformance certificate are TFDA (Taiwan Food Drug In response to the fact that it was accepted by the management authority (TFDA), it became possible to respond as a registered certification body that received the TFDA ‘s witness inspection.
[Image: https://prtimes.jp/i/17062/37/resize/d17062-37-226178-0.jpg]
In the “Memorandum of Cooperation on the Medical Device Quality Management System (QMS) Request for Documentation”, the Japanese Manufacturers shall submit the QMS Conformity Survey Report issued by the Pharmaceuticals and Medical Devices Agency (PMDA) It is stating that translated English or Chinese will be accepted as evidence that TFDA conforms to Taiwan medical device GMP regulation (Chapter 2, Part 3) “. In the past, Japanese manufacturers had to submit “QMS documents (including not only quality manuals but also regulations / procedure manuals)” in English or in Chinese, to TFDA. In this Agreement, it is also necessary to submit a quality manual. Also, TFDA accepts only 4 institutions that have received the TFDA’s witness survey among registered certification bodies, and TÜV SÜD Japan is one of them. At TÜV SÜD Japan, we are planning a seminar on medical device regulation in Taiwan from time to time. We will announce it on our website when the schedule is decided, so please check. www.tuv-sud.jp/jp-jp/activity/training/infoservice/schedule Ministry of Health, Labor and Welfare Related page www.koryu.or.jp/news/?itemid=933&dispmid=4259 TÜV SÜD Japan Related page www.tuv-sud.jp/jp-jp/industry/healthcare-medical-devices/market-approval-amp-certification/japan-market-access_1 Add value. Inspire trust. – New value, further trust TÜV SÜD provides a safe, secure, sustainable solution and continues to be a trusted partner. We have been working on it since 1866 under the philosophy of specializing in testing, inspection, certification and auditing, and protecting people, the environment and property from the risks of technology. With more than 1,000 bases worldwide, we work with more than 24,000 employees to provide customers and partners the value of facilitating risk management and market access. TÜV SÜD will continue to provide trust in the future to help change caused by advances in technology and create a safer and sustainable future in the natural and digital worlds. www.tuv-sud.jp

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