Page 72 - 2020Taiwan Food and Drug Administration Annual Report

Medical Device Act

hThe Legislative Yuan passed the third reading of the
“Medical Devices Act” on December 13, 2019.
hThe Act with 85 articles were announced on January 15, 2020
under the Presidential Decree.
hAllows medical device “designers” to apply for their own license.
hEstablishes a mechanism to give those who develop new
medical devises more flexibility with license issuance.
hAdopting the electronic online registration system for some
low-risk medical devices.
hMedical device repairers are classified as medical device
dealers.
hImplementation of Good Distribution Pardtice (GDP) .

International Cooperation
hHold the APEC Medical Devices Regulatory Science Center of Excellence Pilot Workshop.
hStrive to join the IMDRF Working Group and continue to send staff to participate in the
annual meeting.
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hConduct the 7 Joint Conference of Taiwan and Japan on Medical Products Regulation.
hConduct the Conference on International Medical Device Regulations in South East Asia
and Brazil.
hHosted the Conference on Analytical Techniques for Cosmetics.

Cosmetic Hygiene and Safety Act

hThe act was announced by the President on May 2, 2018.
hThe date of implementation was also be set on July 1, 2019 by the
Executive Yuan, except for the relevant provisions of the information that
shall be labeled on outer packaging or containers of cosmetics will be
implemented on July 1, 2021.
hAnnounced 30 sub-regulations and orders in 2019.
hThe cosmetics businesses shall establish product information file before
the product is introduced on the market.
hCosmetic manufacturing sites shall comply with GMP for the
implementation of quality management.
hThe cosmetics manufacturers should employ a pharmacist or a
professional cosmetic technical personnel to be stationed in the factory
to supervise the production and manufacturing.
hStipulated the implementation methods of recycling, Establish product
source and flow data, and proactive notification system.
hFormulate relevant regulations such as promotional phrases and
incentives.