Page 124 - 2018食藥署年報(英文版)

Date Title Key amendments

A total of five class II medical devices, namely blood
Revised the “Registration of pressure tourniquets, menstrual cups, motorized
Requirements of Distance vehicle for medical purposes, powered wheelchairs and
March 16 sales Purchases of medical otolaryngology drug application devices, and throat cloth
Devices by pharmaceutical application device, promoting consumers can now be
Companies” purchases through distance sales. Improve convenience
of people’s accessing medical devices.

The rationalized application required documents when
registration of medical devices. Open online registration
Partial revision of the of the class I medical devices is now available. In order to
March 30 “Regulation for Registration avoid confusion, the English and Chinese product name
of Medical Devices” of registration of medical devices exclusively for export
should not be the same as domestic medical devices
licenses.

Revise “Regulations for Cosmetics containing Titanium dioxide (with the exception
April 14 cosmetics containing Titanium of nanomaterials and products in spray form) below 25%
dioxide” are subjected to the regulations for general cosmetics.

Promulgate “Requirements For nail polish containing organic solvents, it is required
for Additional Information on to add notes such as “keep good ventilation” and “keep
May 26
Nail Cosmetics Added with away from fire and heat” to the labeling, package inserts
Organic Solvents” or packaging.

Release of four guidance
documents, include:
“ Technical St andard:
Control Materials for In vitro
Diagnostic Medical Device,” In order to improve the safety and effectiveness of in vitro
“Technical Standard: Dengue diagnostic medical devices, the four guidance documents
July 17 Virus Serological Reagents,” on medical device were released as references for
“ Technical St andard: manufacturers which are developing relevant products
Pretreatment Systems for and preparing submission dossiers for registration.
Nucleic Acids,” and “Technical
Standard: Reagents for
Detecting Nucleic Acids of
Influenza Virus.”
Through the combination of energies (current, ultrasound,
Revise “Regulations for etc.) into the skin, and providing claims that it poses
Governing the Management medical efficacy (which is, eliminating fine lines, promoting
July 25 of Medical Device” Article 3 the proliferation of collagen and elastic fiber and others),
Annex 1 and Article 4 Annex incorporated into the management of medical device,
2 allowing both the industries and the general public to have
a guideline to follow.

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