Page 18 - 2021 Taiwan Food and Drug Administration Annual Report

lifecycle management system for medical FRQVXPHUV EXVLQHVV RSHUDWRUV DQG WKH JRY-
GHYLFHV FRYHULQJ YDULRXV DVSHFWV LQFOXGLQJ ernment.

internationalization of regulatory manage- II. Cosmetics Management frame-
PHQW IORZ FRQWURO SUH PDUNHW LQVSHFWLRQV work
SRVW PDUNHW PRQLWRULQJ PDQDJHPHQW RI
PHGLFDO GHYLFH ¿UPV DQG SURGXFW FLUFXODWLRQ The current cosmetics management
system includes three parts: production
management (Figure 1-7). The system can VRXUFH FRQWURO SUH PDUNHW PDQDJHPHQW DQG
HIIHFWLYHO\ FRQWURO WKH VDIHW\ HIILFDF\ DQG post-market surveillance (Figure 1-8). The
TXDOLW\ RI PHGLFDO GHYLFHV DW WKH VDPH WLPH production source control includes ensuring
that manufacturers comply with the Estab-
it can continue to facilitate the development lishment Standards for Cosmetics Manufac-

of the biotechnology and the pharmaceutical
LQGXVWU\ VR WR FUHDWH D ZLQ ZLQ VLWXDWLRQ IRU

Product design/ Pre-clinical Clinical trial Pre-market Production Post-market
Prototype validation Application

development

Device Class and Good Laboratory Clinical trial Pre-market control Post-market surveillance
Regulatory Controls Practice for
inspection (GCP)
Nonclinical Labo-
ratory Studies Clinical trial Registration
(GLP/GTP) protocol review (Approval/Listing)

(TFDA/IRB)

Product Quality System Control Medical device advisory committee

Manufacturer Quality Management System (QMS) ADR & defective product
General / Case-Specific Consultation reporting

Safety surveillance &
alert collection

Good Distribution Practice
(GDP)

Tracking manegment
(UDI)

Consumer health education
and awareness

Figure1-7 Full life-cycle management structure for medical devices

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