G/TBT/N/BRA/1203  
7 July 2021  
(21-5367) 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:  BRAZIL   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Brazilian Health Regulatory Agency (ANVISA)  
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 indicated if different from above:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
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):  
Instruments and appliances used in medical, surgical, dental or veterinary sciences, incl. 
scintigraphic apparatus, other electro -medical apparatus and sight -testing instruments, 
n.e.s (HS 9018); Appa ratus based on the use of X -rays or of alpha, beta or gamma 
radiations, whether or not for medical, surgical, dental or veterinary uses, incl. 
radiography or radiotherapy apparatus, X -ray tubes and other X -ray generators, high 
tension generators, control p anels and desks, screens, examination or treatment tables, 
chairs and the like (HS 9022)  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
number 1051, 28 June 2021 (2 page(s), in Portuguese)  
6. Description of content:  Draft Resolution No. 1051 disposes the positive identification 
of medical devices regulated at Anvisa, through the Unique Identification of Medical 
Devices (UDI) system.  
Comment form: https://pesquisa.anvisa.gov.br/index.php/931146?lang=pt -BR 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The UDI system aims to provide a simple and globally harmonic positive 
identification of medical devices through distribution and use, requiring the device label 
to accept a unique global device identifier (to be expressed by Automatic Identification 
Data Capture and, if applicable, Human Readable Interpretation) based on a standard: 
the UDI -DI of that unique global identifier being linked to a UDI database of a specific 
jurisdiction; Protection of human health or safety  G/TBT/N/BRA/1203  
 
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  8. Relevant documents:  01) Brazili an Official Gazette 121 on 30 June 2021, section 1, 
page 161; 02) RIA dispensation motivations  
https://www.in.gov.br/web/dou/ -/resolucao -rdc-n-521-de-23-de-junho-de-2021-
329125498  
http://antigo.anvisa.gov.br/documents/10181/6292482/Parecer+ -
+Dispensa+de+AIR/50a0b7ff -25d0-4b5d-bacc-531992f9a1a3  
9. Propo sed date of adoption:  Not applied  
Proposed date of entry into force:  Not applied  
10. Final date for comments:  6 September 2021  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://antigo.anvisa.gov.br/documents/10181/629248 2/%281%29CONSULTA+P%C3%
9ABLICA+N+1051+GGTPS.pdf/a56dfa95 -a61c-4680-8ebe-2bb40d05508e