Page 51 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Chapter 4. Medical Devices Management

The medical device industry is poised to become Taiwan's leading biotech industry in terms
of development potential, given its rapid developments in technology and growing demands for
healthcare technologies due to the aging of Taiwan's society. In response to growing prospects
of the medical device industry in Taiwan, the TFDA has established a Total Product Life Cycle
(TPLC) management policy for medical devices (Figure 2-4-1) that includes harmonization with
international standards and regulations, production source control, pre-market gatekeeping,
post-market surveillance, management of pharmaceutical companies and product distribution
channels, and provision of professional counseling services. The purpose of the TPLC policy is Part II - Key Administrative Results Medical Devices Management
to effectively control the safety, effectiveness, and quality of medical devices, and to promote
developments of Taiwan's biotech and pharmaceutical industry, creating an environment
bene?cial for consumers, industry, and government.

Medical Care Needs Product Design Preclinical Premarket Production Post-market
/ Fundamental Study / Prototype validation Clinical trial application surveillance
Development

General / Clinical trial
Special case Good Laboratory inspection (GCP) Pre-market control
Practice
consultation
(GLP/GTP)
Clinical trial protocol
Product review (TFDA/IRB)
Designation Registration
(Approval / Listing)
Medical device advisory committee

Production
source control Manufacturer’s quality system audit (GMP)

Defective product /
GLP ：Good Laboratory Practice adverse event reporting (ADR)
GTP：Good Tissue Practice
GCP：Good Clinical Practice Safety surveillance &
IRB：Institutional Review Board alert collection (GVP)
GMP：Good Manufacturing Practice
ADR：Adverse Drug/Device Reactions Consumer health education
and awareness
GVP：Good Vigilance Practice
GDP：Good Distribution Practice Good Distribution Practice (GDP)

Post-market surveillance

Figure 2-4-1 Total product life cycle management system for medical devices in Taiwan

Section 1. Medical Device Regulatory Standards and Product Review
Current Status

To strengthen the pre-market management over medical device safety, effectiveness, and
quality, TFDA implements regulatory review of pre-clinical testing, clinical trials, and product
testing standards for registration. The provision of regulatory consultation and special case
assistance for domestic applications of innovative research and development is a key foundation
to facilitate the development of the industry.

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