1.

Notifying Member: THE SEPARATE CUSTOMS TERRITORY OF TAIWAN, PENGHU, KINMEN AND MATSU

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible:

Food and Drug Administration, Ministry of Health and Welfare

No.161-2, Kunyang St, Nangang District, Taipei City 115209, Taiwan

TEL : 886-2-2787-7523

E-mail: f707450@fda.gov.tw

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Medical device: Medical Equipment (ICS 11.040)

5.

Title, number of pages and language(s) of the notified document: Draft Amendments to Article 7 and to the Annex to Article 4 of the "Regulations Governing the Classification of Medical Devices"; (43 page(s), in English), (27 page(s), in Chinese)

6.

Description of content: As medical devices involve a variety of scientific fields, their types, items, and compositions are complex and rapidly changing. To clarify the scope of medical devices subject to management, we have reviewed the contents of the Annex to Article 4 of the "Regulations Governing the Classification of Medical Devices" and made appropriate revisions based on international management approaches and the current situation. It is recognized that medical device firms should be given a grace period to respond to the amendments, and Article 7 has been amended accordingly. The proposed amendments are as follows: (1) The date of entering into force for the new product items in Article 4. (Amendment to Article 7); (2) 64 product items have been added. (Amendment to the Annex to Article 4)

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety; Harmonization

8.

Relevant documents:

Medical Devices Act

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Final date for comments: 60 days from notification

11.

Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:

WTO/TBT Enquiry Point

Bureau of Standards, Metrology and Inspection

Ministry of Economic Affairs

No. 4, Sec. 1, Jinan Rd., Zhongzheng Dist.

Taipei City 100, Taiwan

Tel: +(886-2) 23431916

Fax: +(886-2) 23431804

Email: tbtenq@bsmi.gov.tw

https://members.wto.org/crnattachments/2023/TBT/TPKM/23_2138_00_e.pdf

https://members.wto.org/crnattachments/2023/TBT/TPKM/23_2138_01_e.pdf

https://members.wto.org/crnattachments/2023/TBT/TPKM/23_2138_00_x.pdf

https://members.wto.org/crnattachments/2023/TBT/TPKM/23_2138_01_x.pdf