Page 130 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

Date Title Summary
This practice was established to ensure that medical devices
can be maintained at the quality specified by the original
June Promulgated the Good Distribution
manufacturer during distribution and sales activities performed
18 Practice for Medical Devices
by the importers, dealers, and pharmacies while ensuring that
product distribution safeguards public health and safety.
To ensure the safety and effectiveness of IVDD, TFDA announced
4 IVDD testing guidance documents, including one for human
July Announced testing guidance
papillomavirus testing, that provide reference for businesses
21 documents for 4 IVDD
in product research and development as well as preparation of
documents when applying for product registration.
Announced the List of Recognized To provide the industry standards that can be referenced when
Standards for Medical Devices researching, developing, and manufacturing medical devices,
September in 2015 and the List of Originally TFDA announced a list of 918 recognized standards for medical
1 Recognized Standards for Medical devices which included 449 newly recognized standards and
Devices that Have Been Withdrawn 469 originally recognized standards that have not undergone
or Revised revision changes or withdrawn.
There is currently no global consensus or recognized standards
Promulgated Reminders for the for the risks or benefits of nanotechnology medical devices. To
September
Management of Nanotechnology support the technological development of relevant industries,
24
Medical Devices these reminders were provided as a reference for the quality
management systems of related product manufacturers.
Promulgated an amendment to After permitting the online sale of 726 items (including Class 1
the Annex of Paragraph 1 in the and some Class 2 medical devices) by pharmaceutical firms
October
Registration Requirements of starting in 2012, eight more items were added in 2015 to provide
15
Mail-Order Purchases for Medical consumers the convenience of purchasing medical devices by
Devices diverse ways.
Promulgated the Good Clinical Strengthened the protection of rights, safety, and welfare of
October
Practice for Trial Operations of trial subjects, and provided as a reference for businesses and
16
Medical Devices hospitals engaged in the clinical trials of medical devices.
Promulgated the Regulation of Announced globally acceptable specifications for unique device
October
Unique Device Identification (UDI) identification coding and barcodes that facilitate establishment
30
System for Medical Devices of the basis for automated distribution management.
Table 16. Additions and revisions to relevant regulations and hygiene
standards for cosmetics in 2015
Date Title Summary
Triclocarban was listed as an ingredient of medicated
Formulated the Ingredient Standards for
January cosmetic, and must be registered accordingly on the day that
Triclocarban as Cosmetics Containing
12 the standards enter into force. No manufacturing or import
Medical or Poisonous Drugs
shall be allowed until a license is approved and issued.
Revised Fee-Charging Standards for the Registration of
Fee-charging standards for cosmetic
Cosmetic Products and Cosmetic Colorants as well as Fee-
registration and advertisement
Charging Standards for the Review of Medicament and
examination
April Cosmetic Advertisements.
7 Revised Basic Technical Information
Added the requirement that safety tests shall prioritize non-
of Medicated Cosmetics with New
animal alternative testing methods that are scientifically
Compounds as Ingredients for
sound, reasonable, and supported by evidence.
Registration
April Formulated the Prohibition of Coal Tar Usage and sales of cosmetics containing coal tar were
20 as Cosmetic Ingredient prohibited starting on January 1, 2016.
Promulgated physical and chemical properties and safety
Formulated the Guidelines for Safety
July evaluation items for cosmetics containing nanotechnology
Assessments of Cosmetics Using
7 components, which could be provided to businesses as a
Nanomaterals as Ingredients
reference during development phases.
Re-categorized the list of legally permitted cosmetic
July Revised the List of Legally Permitted colorants, revised the usage scope of various colorants, and
15 Cosmetic Colorants removed 20 legally permitted cosmetic colorants including CI
128 11380.