Page 79 - 2018食藥署年報(英文版)

Outcomes and Benefits

1. Advancing R&D and product innovation in the medical device industry

The term of “Medical Device Manufacturer” is defined according to the key process in
medical device manufacturing. Medical device designers can also be the permit holders to provide
incentives for the industry, academia, and research institutions to research and develop high-end
medical devices. The conditional approval mechanism is introduced along with post-approval
study or safety surveillance to expedite the entry of innovative medical devices into the market.

2. Promoting diversified management of the medical device industry

Medical device rental or repair businesses are considered as Medical Device Dealers. It
is required that technicians be hired for the different sectors in the medical device industry to
enhance professional management and ensure product safety.

3. Normalizing product destination and distribution quality management
It is specified that Medical Device Dealers and medical institutions shall create and preserve

data of direct supply sources and destinations of products. Medical device distribution quality
of medical devices is promoted to ensure that the quality of products is not compromised during
transportation.
4. Consolidating medical device risk management system

For certain low-risk medical devices, the electronic online register system is adopted in
order to streamline the pre-marketing application process. In addition, annual declaration applied
to extend the validity of registration and urge timely update to the information of listed medical
devices.

5. Constructing medical device clinical trial management

Applicable regulations on clinical trials of medical devices are separated to improve the
management system, ensure the safety and rights of trial subjects, and fulfill the requirements on
management of clinical trials on medical devices.

6. Promoting listed medical device safety surveillance management
It is specified that medical institutions shall cooperate to implement the medical device
safety surveillance system and urge manufacturers to conduct spontaneous monitoring and

management of listed product risks and adopt corrective and preventive measures to protect the
safety of consumers. (See Figure 5-2 for Highlights of the Medical Devices Act and Its Benefits.)

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