Page 100 - 2023 Taiwan Health and Welfare Report

07 2023 Taiwan Health and Welfare Report 07

Chapter 3 Management of Medical 2. In 2022, the Ministry completed the review of a
Devices and Cosmetics total of 188 applications for registration and market
approval of medical devices with no predicate
To effectively control the safety and quality of
products. The average review duration is 151 days.
medical devices and cosmetics, a comprehensive
Compared to 2021, the review efficiency has been
quality management policy was drafted, covering various
improved by 6%, bringing it on par with international
aspects, including international regulatory harmonization,
tracking management, pre-market inspections, post- standards. Detailed statistics on reviewed
market surveillance and supply chain management. applications and licenses granted are shown in
Table 7-7.
Section 1 Regulatory Standards and
3. In 2022, AI/ML Medical Device Project Office
Product Review of Medical
openly solicited proposals and proactively provided
Devices and Cosmetics consultation and guidance for 10 applications.
1. The regulatory environment was changed Additionally, the Office organized 5 matchmaking
to enhance harmonization with international events. As a result, 6 applications of domestic
regulations. Major additions and amendments in artificial intelligence-based software as a medical
2022 are shown in Table 7-6. device successfully obtained licenses.

Major Additions and Amendments to Regulations for Governing Medical
Table 7-6
Devices and Cosmetics in 2022

Date Name
Formulated the "Guidelines for Registration and Market Approval of Artificial Intelligence/Machine
Feb. 14 Learning-Based Software as a Medical Device (AI/ML-Based SaMD) for Computer-Aided Triage
(CADt) "
Formulated the "Reference for the Use of Real-World Data and Evidence to Support Regulatory
Apr. 22
Decision-Making for Medical Devices"
Jun. 16 Amended Article 4 of the "Regulations for the Cosmetic Product Information File Management"
Amended the "Regulations Governing Border Inspection and Examination of Imported Medical
Jul. 8
Devices"
Aug. 17 Amended the "Guidelines for Safety of Children Cosmetics"
Formulated the "Technical Guidelines for the Registration and Market Approval of Artificial
Aug. 31 Intelligence/Machine Learning-Based Software as a Medical Device (AI/ML-Based SaMD) for
Computer-Aided Detection (CADe) and Computer-Aided Diagnosis (CADx)"
Source: Taiwan Food and Drug Administration

Statistics of Reviewed Applications of Medical Devices and Cosmetic and
Table 7-7
Licenses in 2022

Listing of Medical Registration and Market Approval Registration and Market Approval
Items
Devices of Medical Devices for Specific Purpose Cosmetics
Number of
applications received 364 3,640 945
Number of registered
3,323 44,053 14,290
/ valid licenses
Source: Taiwan Food and Drug Administration

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