   
  
G/TBT/N/BRA/842/Add.2  
 
13 September 2021  
(21-6745) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  13 September 2021 , is being circulated at the request of the 
delegation of Brazil . 
 
_______________  
 
 
Title: Resolution – RDC number 305, 24 September 2019  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[  ] Notified measure published - date:  
[  ] Notified measure enters into force - date:  
[  ] Text of final measure available from1:  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[X] Content or scope of notified measure changed  and text available from1: 
http://antigo.anvisa.gov.br/documents/10181/6320987/RDC_562_2021_.pdf/17968eb
3-dcef-4152-b644-5cccacd23f39  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  The Resolution number 305, 24 September 2019 - previously notified through 
G/TBT/N/BRA/842/Add.1  - which disposes about requirements for manufacturing, trading, importing 
and exposure to the use of personalized medical devices, was changed by Resolution – number 562, 
1 September 2021.   
The final text is available only in Portuguese and can be downloaded at:   
http://antigo.anvisa.gov.br /documents/10181/6320987/RDC_562_2021_.pdf/17968eb3 -dcef-
4152-b644-5cccacd23f39  
__________  
 
 
 
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.  