Page 84 - 2023 Taiwan Food and Drug Administration Annual Report

2023 Taiwan Food and
Drug Administration

Annual Report

Section 5 Welfare also announced on January 3, 2022, to
entrust TFDA with laboratory certification.
Improved Testing
Technologies for ▍ Implementation Strategy
Medical Devices
and Cosmetics and By constantly advancing the testing
Management over and analysis capabilities of laboratories,
Molecular Testing introducing emerging testing technologies,
Laboratories extablishing testing methods, and preparing
technical documents for reference and use by
▍ Introduction of the Policy all parties, TFDA comprehensively improves
the technical level of tests performed, ensures
Emerging medical devices and cosmetics the quality and safety of products and boosts
are growing at a rapid rate and hence it is the test capacity in our nation. Proactively
urgent to create technical platforms to support taking part in periodic meetings and technical
the qualification of various types of products, events of international organizations,
maximize test items, and develop or optimize exchanging and sharing progress made in
the test methods to cope with domestic needs testing technologies to keep track of the
for the management of products. Meanwhile, international testing status and trends as
the status and trends of tests around the world well as obtaining the latest information on
shall be kept track of through international substances of international interest enhance
technical exchange and collaboration in the testing technologies in our country to be in
order to comprehensively boost the technical line with international counterparts. Establish
level of tests and to reinforce the research the “Application Guidelines for Accreditation
capabilities of TFDA to be comparable of Precision Medicine Molecular Testing
to those of international counterparts. In Laboratories” and help businesses know
addition, for the sake of ensuring the quality for sure related application requirements.
of molecular testing laboratories for precision Accreditation has been available since July
medicine in the nation, TFDA established 1, 2022. Laboratories are confirmed to meet
the relevant operating regulations for requirements through document review, on-
registration of precision medicine molecular site inspections, and reviews, among other
testing laboratories and embarked on related procedures and the quality of tests performed
operations in 2019. The Ministry of Health and by laboratories continues to be monitored
through systems such as proficiency testing,
82 aperiodic inspections, and inspections for an
extension of the effective period, etc.