. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/370 
17 May 2010  
 (10-2734) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  BRAZIL
  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Sanitary Surveillance 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, Standard ization and Industrial Quality – INMETRO 
Tel.:  +(55) 21 2563 2821 Fax:  +(55) 21 2502 6542 E-mail:  barreirastecnicas@inmetro.gov.br Website:  http://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 applicab le, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):  Medical gases.  
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution 
n° 17, 25 February 2010 – Medical gas companies (8 pages, Portuguese)     
6. Description of content:  This technical regulation settles operation rules for medical gas 
companies.  
This draft Resolution established the minimum requirements to be fulfilled by 
manufacturers of medical gases to get the operating permit from Anvisa. 
For the purpose of this draft Resolution, medical  gases are defined as a gas or a mixture of 
gases for treating or preventing diseases in human beings or to be administered to humans for the purpose of medical diagnosis or to restore, to correct or to modify physiological functions.    
The medical gas companies or manufacturers mu st have adequate infrastructure, it must 
adopt administrative procedures and it must also demonstrate through documentation technical and operational capacity for manufact uring and control of medical gases with 
quality, safety and efficacy. 
The establishments covered by this Resolution will have a period of 12 months to promote 
the necessary adjustments to comply with the pr ovisions of this Reso lution after its entry 
into force.  G/TBT/N/BRA/370 
Page 2  
 
  7. Objective and rationale, including the natu re of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  
8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), 2 March 2010; 
Section 1. Draft Resolution (Consulta Pública) number 17, 25 February 2010, issued by Brazilian Sanitary Surveillance Agency – A nvisa; When adopted, it will be published at 
Brazilian Official Journal.  Available in Portuguese.   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    To be determined after the end of the 
consultation period.  
On the date of adoption. 
10. Final date for comments:  2 April 2010 
11. Text available from: National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:    
National enquiry point 
Agency responsible Brazilian Sanitary Surveillance Agency – ANVISA SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil 
CEP:  71.205-050 
Tel.:  55 61 3462-5402 E-mail:  rel@anvisa.gov.br  Website:  http://www.anvisa.gov.br
 
http://portal.anvisa.gov.br/wps/wcm/conn ect/b0b1ca80419a766387 bcc756e8016762/CP+N
%C2%BA+17+GGIMP.pdf?MOD=AJPERES