G/TBT/N/BRA/626  
 
9 March 2015  
(15-1313)  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: ANVISA – Brazilian Health Surveillance Agency 
Name and address (including telephon e 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 2563.2840 
Telefax: +(55) 21 2563.5637 Email: barreirastecnicas@inmetro.gov.br   
Web-site: http://www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=19051  
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Medical devices 
emitting ionizing radiation in health services 
5. Title, number of pages and language(s) of the notified document: Draft Technical 
Resolution Nº 06, 4 February 2015, Regarding Good Practices for Operation, Safety and Quality of Diagnostic Imaging Health Services that Use Equipments that Emit Ionizing Radiation (6 pages, in Portuguese)  
6. Description of content: Draft Technical Resolution nº 06, 4 February 2015, regarding 
good practices for operation, safety and quality of diagnostic imaging health services that 
use equipments that emit ionizing radiation.  
This draft Technical Resolution has the goal of  establishing requirements of good practices 
of operation of diagnostic imaging services that use equipments emitting ionizing radiation 
in health, contemplating the management of risks inherent to the technologies used. 
The Technical Resolution applies to all the diagnostic imaging services that use those 
products in Brazil, even though it is public, private, philanthropic, civil or military, including 
those which practice teaching and research actions. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety  
8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), 9 February 2015; 
Section 1, p. 27, Draft Resolution (Consulta Pública) nº 06, 4 February 2015, issued by 
Brazilian Health Surveillance Agency – Anvisa. When adopted, it will be published at the 
Brazilian Official Journal. Available in Portuguese. G/TBT/N/BRA/626 
 
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  9. Proposed date of adoption: To be determined after the end of the consultation period 
Proposed date of entry into force: To be determined after the end of the consultation 
period   
10. Final date for comments: 18 May 2015 
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Agency responsible 
Brazilian Health Surveillance Agency – ANVISA 
SIA, Trecho 5, Área Especial 57 Brasília – DF/Brazil CEP: 71.205-050 
Phone.: +(55) 61 3462.5402 
Website: http://portal.anvisa.gov.br 
http://portal.anvisa.gov.br/wps/wcm/connect/9aba6e00473e6ca7af14efdbbe781ae8/Consult
a+P%C3%BAblica+n%C2%B0+06+GGTES.pdf?MOD=AJPERES