  
  
G/TBT/N/TPKM/442  
25 November 2020  
(20-8520) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
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 Dist.  
Taipei City 115209, Taiwan  
Tel: +(886 -2) 2787 -8085 
Fax: +(886 -2) 3322 -9492 
Email: hsinchiaoho@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 in dicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Condom s (4014.10.00.10;4014.10.00.90), Medical mask s (6307.90.50.31); Sheath 
contraceptives, of vulcanised rubber (excl. hard rubber) (HS 401410); Made -up articles 
of textile materials, incl. dress patterns, n.e.s (HS 630790)  
5. Title, number  of pages and language(s) of the notified document:  Draft 
Regulations Governing Border Inspection and Examination of Imported Medical Devices 
(12 page(s), in English; 10 page(s), in Chinese)  
6. Description of content:  With a view to ensuring the quality o f medical devices and 
protecting the safety and well -being of the public, Food and Drug Administration, Ministry 
of Health and Welfare proposes to conduct border inspection and examination of imported 
medical devices.  
7. Objective and rationale, including  the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
• Medical Devices Act  
• CNS14774  
• CNS14755  
• CNS6629  G/TBT/N/TPKM/442  
 
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  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) 3343 -5140  
Fax: +(886 2) 2343 -1804  
E-mail: tbtenq@bsmi.gov.tw  
https://members.wto.org/crnattachments/2020/TBT/TPKM/20_7249_00_e.pdf  
https://members.wto .org/crnattachments/2020/TBT/TPKM/20_7249_00_x.pdf  
 