Page 15 - 2018食藥署年報(英文版)

to the necessity of controlled drugs in medical or scientific application the “Controlled Drugs Act”
has been established to give a control framework, which is composed of licensing, scheduling,
and diversion management. (Figure 1-4)

3. Medical devices management framework

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. In response to the 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 1-5) that includes harmonization with international standards and
regulations, production source control, pre-market control, post-market surveillance, management
of pharmaceutical companies and product distribution channels, and provision of professional
counseling services. The purpose of the TPLC policy is to effectively control the safety,
performance, and quality of medical devices, and to promote the developments of Taiwan's
biotech and pharmaceutical industry, in order to create an environment beneficial for consumers,
industry, and government.

Medical care needs / Product design / Preclinical Clinical trial Pre-market Production Post-market
Prototype
Fundamental study development validation application surveillance
General/ case specific Good Laboratory Clinical trial Pre-market
consultation Practice for inspection (GCP) control
Nonclinical
Product designation Laboratory Studies
(GLP) Clinical trial Registration
protocol review (Approval/Listing)
(TFDA/IRB)

Medical device advisory committee

Production Quality System Control Manufacturer’s quality system audit (GMP)

GLP ：Good Laboratory Practice ADR & defective product reporting
GCP ：Good Clinical Practice
IRB ：Institutional Review Board Safety surveillance & alert collection (GVP)
GMP：Good Manufacturing Practice
ADR ：Adverse Drug/Device Reactions
GVP ：Good Vigilance Practices Consumer health education and awareness
GDP ：Good Distribution Practice
Good distribution practice (GDP)
Post-market surveillance

Figure1-5 Total product life cycle management policy for medical devices

13