Page 84 - 2019食藥署年報(英文版)

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To enhance the manufacturer’s quality of imported medical devices products, reduce the
risk of medical devices on the market, promote the on-site inspection on overseas manufacturers
of medical devices, reinforce the supervision responsibility in the pre-market and post-market
stage for the imported medical devices, and establish a management model of medical device
manufacturers for risk management.

Besides, on November 5, 2013, the Taiwan-Japan Relations Association (formerly known
as the East Asia Relations Association) and the Japan-Taiwan Exchange Association (formerly
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the cooperation of laws and regulations in drugs between Taiwan and Japan." After signing the
agreement, TFDA and the Ministry of Health, Labor and Welfare of Japan (MHLW) and the
Pharmaceuticals and Medical Devices Agency (PMDA) had established a working group for the
Quality Management System (QMS) of medical devices, to reinforce the cooperation between

the two countries.

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To establish a risk management mechanism for on-site inspection on overseas
manufacturers of imported medical devices, TFDA announced the priority items and schedules
of implementation for the on-site inspection on overseas manufacturers of imported medical
devices (Table 5-1). The regulations stipulate that the medical device manufacturers with the
following products shall apply for on-site inspection due to the establishment, relocation,
expansion and reinstatement of overseas manufacturers of the imported medical devices.

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