  
  
G/TBT/N/TPKM/449  
5 January 2021  
(21-0126) 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 -8078 
Email: menghan1215@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 [   ], 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):  Medical 
devices; Medical equipment (ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  Draft of the 
Enforcement Rules of Medical Devices Act (8 page(s), in English; 9 page(s), in Chinese)  
6. Description of conten t: With a view to implementing the Medical Devices Act, which 
was promulgated on 15 January 2020, the Ministry of Health and Welfare is proposing to 
draft the ''Enforcement Rules of Medical Device Act'' to provide further details. The 
provisions of the dra ft enforcement rules include: terms, registration of medical device 
firms, regulations on labeling, regulations on approval of medical device advertisements 
and rewards for reporting violations, etc.  
7. Objective and rationale, including the nature of urg ent problems where 
applicable:  Consumer information, labelling; Protection of human health or safety  
8. Relevant documents:   
• Medical Devices Act 
http://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030106  
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  G/TBT/N/TPKM/449  
 
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  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/2021/TBT/TPKM/21_0161_00_et.pdf  
https://members.wto.org/crna ttachments/2021/TBT/TPKM/21_0161_00_x.pdf  
 