Page 28 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

(3) Medical devices and cosmetics legal environment
A. The management and the business running model of medical devices and
medicinal products are significantly different. To implement medical device risk
classifications, achieve medical device management, establish medical device
manufacturing and distribution quality system, reinforce clinical trial regulations
for medical devices and complete safety surveillance mechanisms of marketing
products, “Draft for Medical Devices Act” is established to comprehend the total
product life cycle management system for medical device. Five forums and 6
regulatory advisory board meetings were convened in 2016. On December 5,
2016, a draft was promulgated to invite comments from all fields.

B. Draft the “Amendment of the Statute for Control of Cosmetic Hygiene” to align
with the trend of international cosmetics management and respond to current
needs. The key points of the Amendment include replacing registration system of
medicated cosmetics to product notification system and product information file
(PIF), and establishing mandatory GMP regulation that cosmetic manufacturers
must comply with. The Amendment was submitted to Legislative Yuan on
September 9, 2016 (Figure 2-4).

Amended
Elevate the legal level of Definition of
cosmetics
Control of Cosmetic Hygiene Added
from “Statute” to “Act” Added
ADR reporting Product registration
Boarder inspections PIF establishment
Requirements on Comprehensive
product withdrawal GMP
Act for Control and recalls implementation
Emphasized
of Cosmetic Management responsi-
Hygiene bilities of business
owner Imposed
Temporarily Heavy penalties for Abolished
willful violators
Preliminary
retained
Statute for Control Registration of examination of
advertisement
of Cosmetic specific purpose Registration of
Hygiene cosmetics (transition colorants
period)
Increased
fines
Abolished criminal
sentencing
Added whistleblower
clauses
Figure 2-4 Key revisions of the Amendment of the Statute for Control of Cosmetic Hygiene

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