Page 123 - 2018食藥署年報(英文版)

Table 6 Promulgation and amendment of regulations and standards related to

medical device and cosmetics in 2017

Date Title Key amendments

The document “Priority Review Program for Medical
Device” is released to encourage the development of
Release of “Priority Review innovative medical devices, as well as medical devices
January 9
Program for Medical Devices” in urgent demand in the domestic market. This program
allows the TFDA to shorten the review timeline in order to
benefit the life of patients and the public health.

Revise “Scope and categories of cosmetics” based on
Revise “Scope and categories the international management and the commercial forms
February 3
of cosmetics” of the cosmetics to respond to the diversity of newly
developed cosmetics products.

It is required to re-stipulate application limitations of
Pro mu l g a te “ L i st o f antimicrobial agents due to the overlaps of components
February 15 Antimicrobials Allowed in in preservatives and antimicrobials, and the differences
Cosmetic Products” between application levels and notes among the two
products.

To protect consumer’s health and safety, meet the
Revise “List of Preservatives international trend and stipulate easy-to-follow regulations,
February 15 Al l o w e d i n C o s me ti c the amendment on “List of Preservatives Allowed in
Products” Cosmetic Products” is based on the revised table of
standards for preservatives.

Cosmetics that are certified and licensed as organic
Issue official letters to products, it is allowed to publish the name or the logo of
describe “The principles for the certification institute under the approval of the original
the management of labeling
February 18 certification institute. It is the business’s responsibility to
and advert isement f or provide relevant evidence of certification. In addition, the
cosmetics containing organic business is not allowed to use terms “organic cosmetics”
ingredients”
in any part of the product name.

Include registration and extension requirements in the
Revise “ Operational operational standards to facilitate businesses understand
standards for medicated
February 22 relevant laws and regulations, and then revise the title
cosmetics and cosmetics dye of the standard to “Review Criteria for Registration of
registration”
Medicated Cosmetics and Cosmetic Colorants.”

List alternative approaches for use when there is no
Release of the amendments equivalent IVD available for comparison study. Amend
to “Guidelines for Registration
March 15 the requirements for high-risk IVDs (e.g., HIV assays).
of In Vitro Diagnostic Medical Introduce new requirements specific for reagents used to
Device”
detect nucleic acids.

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