Page 110 - 2022 Taiwan Health and Welfare Report

Table 7-7
Statistics of Applications for Review of Medical Devices and Cosmetic and Permits in 2021
Items
Listing of Medical Devices
Registration and Market Approval of Medical Devices
Registration and Market Approval for Specific Purpose Cosmetics
Number of applications received
80
4,825
1,055
Number of listing/valid licenses
3,303*
47,635
16,578
Note : A total of 3,223 medical device licenses were transferred to the listing system in 2021
Source : Taiwan Food and Drug Administration
3. On October 1, 2021, the listing and annual declaration system was officially implemented for low-risk Class I medical devices. A total of 187 applications for registration and market approval of medical devices with no predicate product were completed. In average, the review took 160.4 days, which was similar to the global average. Statistics of the applications for review and permits are shown in Table 7-7.
4. On May 7, 2021, the Intelligent Medical Device Project Office was established to actively facilitate the research and development of Artificial Intelligent-Based Software as a Medical Device in Taiwan. A total of 67 education and training sessions and regulation briefings were held and 5 applications of Artificial Intelligent-Based Software as a Medical Device received licenses successfully.
5. In response to the COVID-19 pandemic, TFDA has initiated fast-track services and established a consultation team to review and approve a total of 123 applications of manufacturing medical devices as a special case for endemic prevention and 218 applications of importing medical devices as a special case, including test reagent, computer- aided detection software for chest X-ray imaging and respiratory apparatus to enhance Taiwan's capacity to respond to the outbreaks.
6. The Food and Drug Administration participated in the 15th Annual Meeting of International Cooperation on Cosmetics Regulations as an official member. TFDA also organized the 2021
APEC Medical Device Regulatory Science Center of Excellence Seminar to train 66 seed instructors from government, industry, and academia in 14 countries and promote cross- border regulatory harmonization of medical devices and cosmetics.
▏Section 2 Source Management of Medical Devices and
Cosmetics
1.By the end of 2021, a total of 1,206 domestically manufactured medical devices were recognized as complying with GMP; 4,778 imported medical devices were recognized as complying with Quality System Documentation (QSD).
2.By the end of 2021, a total of 333,805 cosmetic products completed notification on the Cosmetic Products Notification Platform System.
▏Section 3 Quality Surveillance of Medical Devices and
Cosmetics
1. Surveillance results of products are shown in Table 7-8. Unqualified products were dealt with according to the law.
2. TFDA worked with local health bureaus to conduct joint inspections. The results are shown in Table 7-9. Products failing to comply with the requirements were disposed according to relevant laws and regulations.
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