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QT Analysis: Registration of Quality Management System in Taiwan & Japan  - August 2021

QT Analysis: Registration of Quality Management System in Taiwan & Japan - August 2021

  • 2021-08-26 13:03:08

One similar thing about the medical device registration process in Taiwan and Japan is the documentation of the Quality Management System that must be registered with the local regulatory authorities before a medical device can be sold in each market. In 2021, there were major revisions made to the process of QMS documentation of which foreign manufacturers and local authorized representatives should be aware. This article will introduce those major revisions, as well as major differences in the QMS registration processes in Taiwan and Japan.

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