Page 85 - 2019食藥署年報(英文版)

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The working group continued to plan for observing regular auditing between the inspection
agencies, to verify a mutually recognized QMS certification body. TFDA assessed that the risk
management of the Japanese medical device manufacturers and then signed a draft Memorandum of
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"Memorandum of cooperation on the Quality Management System of Medical devices" (referred
to as the Taiwan-Japan MOC) was signed in Taiwan at the end of 2018. On November 30, 2018,
our representative from the Taiwan-Japan Relations Association and the Japan representative from
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the Japan-Taiwan Exchange Association signed the Taiwan-Japan MOC at the 43 Taiwan-Japan
Economic and Trade Conference, and the MOC was announced and took effect on December 11,
2018.
The memorandum, which certified four QMS certification bodies (TUV Rheinland
Japan, TUV SUD Japan, SGS Japan, BSI Group Japan), and PMDA by MHLW authorizing,
was conducted by TFDA. Both of the two parties recognize the contents of the audit reports
issued by the abovementioned units within three years, and they have a mutual trust based on
the risk management system for overseas medical device manufacturers. The report from Japan

clearly follows the standard audits of JQMS. It was translated into English and Chinese without
notarization. The documents can be simplified in the QSD procedures for importing medical
devices; in addition, the domestic manufacturers in Taiwan may also translate the TFDA audit
report into an English or Japanese version as a document for entering the Japanese market.

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In 2018, we had completed the on-site practical inspection with high priority and mandatory
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2019. We started the inspection from the manufacturers that produce high-risk cell tissue devices
to the manufacturers that produce products with large impacts and used by a large amount of users,
and the manufacturers that have more defective products notified after the product entering the

market, to protect the health and well-being of the citizens with the quality and risk management in
manufacturers.

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Both of the two parties have mutually agreement on cooperation and implementation based

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