Page 80 - 2018食藥署年報(英文版)

Advancing Promoting
R&D And Diversified
Product Management
Innovation in of the Medical
Medical Device Device
Industry Industry

Covering industrial
Promoting development Normalized
Listed Medi- Product
cal Device Protecting consumers’ Destination
Safety rights and interests and Distribu-
Surveillance tion Quality
Management Improving the medical Management
device management
system

Medical Implementing
Device the Medical
Clinical Trial Device Risk
Management Management
System

Figure 5-2. Highlights of the Medical Devices Act and Its Benefits

Section 2 Review and Consultation for Innovative
Medical Devices

Origin of Policy

The development of medical devices based on innovative technologies has been significantly
accelerated in the past few years. Such medical devices usually employ novel technical principles
or claim new intended uses, however, researchers and developers are faced with the challenge
that there are no similar products or pre-clinical test standards available for reference. In order to
support the R&D teams to develop innovative medical devices, the Administration established

and updated respective standards applicable to medical devices, created a regulatory consultation
network covering the entire product life cycle, and set up a Medical Device Advisory Board
formed by members strong in biomedical engineering and experienced with clinical practice
(Figure 5-3). When it is considered necessary, external experts will also be invited to take part in
the consultation services to provide advice and jointly resolve the regulatory issues confronted by
developers during their development of innovative medical devices.

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