   
  
G/TBT/N/TPKM/409/Add.1  
 
18 May 2021  
(21-4156) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  18 May 2021 , is being circulated at the request of the delegation 
of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu . 
 
_______________  
 
 
Title: Medical Device Quality Management System Regulations  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[X] Notified measure published - date: 14 April 2021  
[X] Notified measure enters into force - date: 1 May 2021  
[X] Text of final measure available from1:  
https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=26932  
[ ] Notified measure withdrawn or revoked - date:  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 "Medical Device Quality Management System Regulations," as per  G/TBT/N/TPKM/409 
on 7 April 2020, was promulgated on 14 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.  