Page 85 - 2018食藥署年報(英文版)

Other Class 2 medical devices that could
be sold on the Internet in 2017

Menstrual cups Blood pressure Otolaryngology drug
tourniquets application devices

Motorized vehicle for
Powered wheelchairs medical purposes

739 items have been allowed to be sold online
(including 721 Class1 medical devices and 18 Class 2 medical devices)
Figure 5-4 Medical devices that pharmaceutical companies (drug stores) may sell through
distance sales channels in 2017

Section 5 Stipulation of Cosmetic Hygiene and Safety Act

Origin of Policy

The Statute for Control of Cosmetic Hygiene has been enforced since December 28, 1972,
and was amended five times. Given trade liberalization and frequent international correspondence
in recent years, current management requirements are becoming more and more insufficient to
meet practical demand.
For reinforced quality and safety of cosmetic products that are available on the market and
to reflect international management trends, the Administration prepared the amended draft of the
Statute for Control of Cosmetic Hygiene that highlights replacement of the medicated cosmetics
registration system with the product notification and product information file system and addition
of the requirement for cosmetic businesses to comply with the Good Manufacturing Practice,
among others, in order to strengthen the hygiene and safety management mechanism for cosmetic
products and to meet the requirements of the Comprehensive and Progressive Agreement for
Trans-Pacific Partnership (CPTPP).

Implementation Measures

1. The Administration began revising the Statute for Control of Cosmetic Hygiene in 2011 and has
been proactively communicating with external representatives. The public hearing on highlights
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