G/TBT/N/BRA/1029  
26 June 2020  
(20-4462) 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:   
Nation al Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
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):  
HS Code(s): medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006); Provitamins 
and vitamins, natural or reproduced by synthesis, incl. natural concentrates, derivatives 
thereof used primarily as vitamins, and intermixtures of the fo regoing, whether or not in 
any solvent (HS 2936); Hormones, prostaglandines, thromboxanes and leukotrienes, 
natural or reproduced by synthesis; derivatives and structural analogues thereof "incl. 
chain modified polypeptides", used primarily as hormones (HS  2937); Dried glands and 
other organs for organo -therapeutic uses, whether or not powdered; extracts of glands or 
other organs or their secretions, for organo -therapeutic uses; heparin and its salts; other 
human or animal substances prepared for therapeuti c or prophylactic uses, n.e.s 
(HS 3001); Human blood; animal blood prepared for therapeutic, prophylactic or 
diagnostic uses; antisera and other blood fractions and modified immunological products, 
whether or not obtained by means of biotechnological proce sses; vaccines, toxins, cultures 
of micro -organisms (excl. yeasts) and similar products (HS 3002); Medicaments consisting 
of two or more constituents mixed together for therapeutic or prophylactic uses, not in 
measured doses or put up for retail sale (excl . goods of heading 3002, 3005 or 3006) 
(HS 3003); Medicaments consisting of mixed or unmixed products for therapeutic or 
prophylactic uses, put up in measured doses "incl. those in the form of transdermal 
administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 
or 3006) (HS 3004); Pharmaceutical preparations and products of subheading 
Nos 3006.10.10 to 3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
no. 823, 12 June  2020 (4 page(s), in Portuguese)  
6. Description of content:  This draft resolution establishes technical requirements for the 
inclusion and updating of notification and market authorization form, product image, 
instructions for use and labelling in the pro cess of regularization of medical devices.  G/TBT/N/BRA/1029  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health; Protection of human health or safety  
8. Relevant documents:  Not applied  
9. Proposed date of adoption:  On the date of the publication of the final text  
Proposed date of entry into force:  On the date of the publication of the final text  
10. Final date for comments:  21 July 2020  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Draft: http://portal.anvisa.gov.br /documents/10181/5916206/CP+823 -
2020.pdf/7efe4668 -5afe-43bd-b691-c529bd88d68a  
Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=57465  
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Bra zil 
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://portal.anvisa .gov.br/documents/10181/5916206/CP+823 -2020.pdf/7efe4668 -5afe-
43bd-b691-c529bd88d68a