Page 102 - 2024 Taiwan Health and Welfare Report

2024 Taiwan Health and Welfare Report

Section 1 Regulatory Standards and 3. In 2023, the office held the AI/ML Medical Device
Innovative Cross-Domain Matchmaking Expo and
Product Review of Medical
completed 3 cross-domain matchmaking exchange
Devices and Cosmetics
seminars, facilitating cross-industry alliances.
1. The regulatory environment was changed Successfully guided 11 domestically-produced
to enhance harmonization with international artificial intelligence medical devices to the market,
regulations. Major additions and amendments in including 3 global pioneering products.
2023 are shown in Table 7-6.
2. In 2023, the Ministry completed the review of a 4. Successfully gained affiliate membership for TFDA
in the International Medical Device Regulators
total of 137 applications for registration and market
approval of medical devices with no predicate Forum (IMDRF), joining working groups to exchange
products. The average review duration is 133.5 with officials from other countries and promoting
days. Compared to 2022, the review efficiency the alignment of Taiwan's medical device regulatory
has been improved by 11%, bringing it on par system with international standards.
with international standards. Detailed statistics on 5. Successfully secured the chairmanship for TFDA
reviewed applications and licenses granted are in the Global Harmonization Working Party
shown in Table 7-7. (GHWP) Technical Committee's Working Group on

Major Additions and Amendments to Regulations for Governing Medical
Table 7-6
Devices and Cosmetics in 2023

Date Name
January Established the "Technical Requirements for SARS-CoV-2 Antigen Diagnostic Test Kits" and
12 "Technical Requirements for SARS-CoV-2 Nucleic Acid Diagnostic Test Kits"
March 2 Established the "Guidelines for Assessing Gender Differences in Medical Device Clinical Trials"

August 15 Established the "Specifications, Test Methods and Performance Requirements for Specific Medical
Devices"
Amended Article 7 and the Annex of Article 4 of the "Regulations Governing the Classification of
August 22 Medical Devices"

October 2 Revised the "Guideline for Cosmetic Product Information File," "Introduction to Cosmetic Product
Information File," and "Checklist for Cosmetic Product Information File"
November Amended certain provisions and the appendix of the "Regulations Governing Issuance of Medical
27 Device License, Listing and Annual Declaration"
Source: Taiwan Food and Drug Administration

Statistics of Reviewed Applications of Medical Devices and Cosmetic and
Table 7-7
Licenses in 2023

Listing of Medical Registration and Market Approval Registration and Market Approval
Items
Devices of Medical Devices for Specific Purpose Cosmetics
Number of 276 3,176 758
applications received
Number of registered
/ valid licenses 3,136 39,693 11,549
Source: Taiwan Food and Drug Administration

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