   
  
G/TBT/N/TPKM/444/Add.1  
 
3 March 2022  
(22-1992) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  3 March 2022 , is being circulated at the request of the 
delegation of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu . 
 
_______________  
 
 
Title: Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[X] Notified measure adopted - date: 1 May 2021  
[X] Notified measure published - date: 29 April 2021  
[X] Notified measure enters into force - date: 1 May 2021  
[X] Text of final measure available from1:  
https://gazette.nat.gov.tw/EG_FileManager/eguploadpub/eg027077/ch08/type1/gov70
/num53/Eg.pdf  
https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030128  
https://members.wto.org/crnattachments/2022/TBT/TPKM/final_measure/22_1913_00
_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/TPKM/final_measure/22_1913_00
_x.pdf  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  The Separate Customs Territory of Taiwan, Penghu, Kinmen  and Matsu would like to 
notify that the "Regulations Governing Issuance of Medical Device License, Listing and Annual 
Declaration," as per G/TBT/N/TPKM/444 on 30 November 2020, was promulgated on 29 April 2021 
and came into effect on 1 May 2021.  
_________ _ 
 
 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  