Page 109 - 2022 Taiwan Health and Welfare Report

7. On December 17, 2021, the First Annual Chinese Medicine Development Yu-Jie Award Ceremony was held, where 13 groups and individuals with major contribution in Chinese medicine were awarded, showing the promotional achievements of Chinese medicine development.
8. Border inspections were performed for 21 Chinese medicinal ingredients such as ginseng and angelica on 1,021 batches out of a total of 2,760 batches (equivalent to 11,325 metric tons) declared by importers in 2021. Fifteen batches were found to be noncompliant and rejected/disposed of accordingly. For monitoring the quality of marketing Chinese medicine products, 5 out of 400 tested random samples failed to pass those tests and received a penalty. In 2021, 189 illegal advertisements of Chinese medicine were detected and fined up to NTD 5,726,200.
9. The "Chinese Medicine Culture Festival" was organized to promote knowledge on Chinese medicine with approximately 7,000 participants.
Chapter 3 Management of Medical Devices and Cosmetics
To effectively control the safety and quality of medical devices and cosmetics, a comprehensive quality management policy was drafted, covering various aspects, including international regulatory harmonization, tracking management, pre-market inspections, post-market surveillance and supply chain management.
▏Section 1 Regulatory Standards and Product Review of Medical
Devices and Cosmetics
1. As the Medical Devices Act takes effect on May 1, 2021, a total of 22 related sub- regulations and 16 rules and orders have been announced. Over 100 applications, forms, and administrative documents have been revised for the implementation of new system.
2. The regulatory environment was changed to enhance harmonization with international regulations, and the revisions in 2021 are shown in Table 7-6.
07
Table 7-6
Major Additions and Amendments to Regulations for Medical Devices and Cosmetics in 2021.
Date
Name
Key Changes of the Revision
May 13
Announced the "Guidance on Preservation Efficacy Test of Cosmetics"
To provide businesses with the references to establish cosmetic product information file.
Jul 7
Announced the "Guidance on Review of Registration and Market Approval of AI/ML- Based CADe SaMD"
To provide businesses references for product development and help them prepare documents for application of registration and market approval.
Oct 19
Announced the "Guidance on Clinical Performance Studies of In Vitro Diagnostic Medical Devices"
Nov 18
Announced "Guidance on Inspection and Registration of Reprocessed Single-use Medical Device"
To be used as a reference for manufacturers and relevant agencies reprocessing single-use medical devices and applying for registration and market approval.
Dec 30
Announced "Guidance on Application for Post-market Changes for Software as Medical Device (SaMD)"
To be used by businesses as a reference for evaluating the application of changes in medical device software post marketing.
Source : Taiwan Food and Drug Administration
107
Management of Food and Drugs