G/TBT/N/BRA/1108  
22 December 2020  
(20-9277) 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):  Ultrasonic 
scanning apparatus (HS 901812); Magnetic resonance imaging apparatus (HS 901813); 
Instruments and appliances used in medical, surgical or veterinary sciences, n.e.s (HS 
901890); X -ray gener ators other than X -ray tubes, high tension generators, control 
panels and desks, screens, examination or treatment tables, chairs and the like, and 
general parts and accessories for apparatus of heading 9022, n.e.s (HS 902290)  
5. Title, number of pages an d language(s) of the notified document:  Normative 
Instruction number 78, 18 November 2020. (30 page(s), in Portuguese)  
6. Description of content:  This Normative Instruction changes the Normative Instructions 
from number 52 to 59, 20 December 2019.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
1) Brazilian Official Gazette 225 on 25 November 2020, section 1, page 155 2) Normative 
Instruction Nº 52 3) Normative Instruction Nº 53 4) Normative Instruction Nº 54 5) 
Normative Instruction Nº 55 6) Normative Instruction Nº 56 7) Normative Instruction Nº 
57 7) Normative Instruction Nº 58 8) Normative Instruction Nº 59.  
https://www.in.gov.br/web/dou/ -/instrucao -normativa -in-n-78-de-18-de-novembro -de-
2020-290045915  
Normative Instruction number 52, December 20th, 2019  
Normative Instruction number 53, December 20th, 2019  G/TBT/N/BRA/1108  
 
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  Normative Instruction number 54, December 20th, 2019  
Normative Instruction number 55, December 20th, 2019  
Normative Instruction number 56, December 20th, 2019  
Normative Instruction number 57, December 20th, 2019  
Norm ative Instruction number 58, December 20th, 2019  
Normative Instruction number 59, December 20th, 2019  
9. Proposed date of adoption:  In the date of its publication.  
Proposed date of entry into force:  In the date of its publication.  
10. Final date for comments:  Not applied.  
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/10181/6126149/IN_78_2020_.pdf/4b5fa443 -
5d2c-45c7-a963-8403dbeae0e8