G/TBT/N/BRA/759  
 
30 November 2017  
(17-6557) 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 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.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): 
Electromedical equipment, Individual sound amplification systems and Washer disinfectors  
5. Title, number of pages and language(s) of the notified document: Normative 
Instruction nº 22, 20 October 2017 (12 page(s), in Portuguese)    
6. Description of content: This Normative Instruction approves the update of Annex I of IN 
4/2015 (IN 4/2015 approved the list of technical standards to be adopted in the 
certification of conformity), and the updating of Annex II of IN 4/2015 (List of dates 
regarding the entrance into force of the standards to be adopted in the certification of 
conformity), withi n the scope of the Brazilian System of Conformity Assessment (SBAC).  
It revokes Normative Instruction 11, 16 December 2014.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant docum ents:  (1) Brazilian Official Journal (Diário Oficial da União) n° 211, 
3 November  2017, section 1, pages 60/61; (2)  Normative Instruction n ° 22, 
20 October  2017; Resolution of the Collegiate Board of Directors - RDC ANVISA 27, 
21 June 2011; (3) Brazilian O fficial Journal; (4) IEC 60601 -2-36:2014; IEC 60601 -2-
40:2016; ISO 9680:2014; IEC 60118 -13:21016; IEC 60601 -1-12:2014; ISO 
7494-1:2011; ISO 7494 -2:2015.   
9. Proposed date of adoption: On the date of its publication  
Proposed date of entry into force: On the date of its publication  G/TBT/N/BRA/759  
 
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  10. Final date for comments: Not applicable  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
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://portal.anvisa.gov.br/documents/33880/2568070/rdc0027_21_06_2011.pdf/a7233  
http://portal.anvisa.gov.br/doc uments/10181/2718376/%282%29IN_04_2015_COMP.pdf/
299347b7 -6cb3-4a0c-aa4c-66b4707a67c6  
http://portal.anvisa.gov.br/docume nts/10181/3682321/IN_22_2017_COMP.pdf/5d9cd051 -
27a3-4e14-8e5d-3788ceb23162