G/TBT/N/BRA/605  
 
4 September 2014  
(14-5015)  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: National Institute of Metrology, Quality and Technology - INMETRO 
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  
Website: http://www.inmetro.gov.br/barreirastecnicas  
3. Notified under Article 2.9.2 [   ], 2.10.1 [   ], 5.6.2 [ X ], 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): Equipment under a 
health surveillance 
5. Title, number of pages and language(s) of the notified document: Ordinance Nº. 407, 
26 August 2014 - Conformity Assessment Procedures for Equipment under a Health 
Surveillance (74 pages, in Portuguese) 
6. Description of content: Establish criteria for Conformity Assessment procedures for 
equipment under health surveillance, attendin g the requirements of the related standards 
in Complementary Documents, for the safety of users.  
These requirements apply to equipment, including parts and accessories, with medical, 
dental, laboratory and physiotherapy purposes, directly or indirectly used for diagnosis, 
treatment, rehabilitation and monitoring in humans; and equipment with the purpose of 
beautification and aesthetics. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Prevention of deceptive practices and consumer protection; Protection of human health or safety.  
8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) Nº 165, 28 
August 2014, section 1, page 94; (2) Resolução do Conselho Nacional de Metrologia, Normalização e Qualidade Industrial - CONM ETRO Nº 04, de 02 de dezembro de 2002; 
Portaria Interministerial MS/MDIC nº 692, de 8 de abril de 2009; Portaria Interministerial 
MS/MDIC nº 16, de 17 de dezembro de 2010; Portaria Ministerial MS/MDIC nº 206, de 21 de junho de 2013; Portaria Inmetro nº 350, de 0 de setembro de 2010; (3) Brazilian 
Official Journal; (4)IEC 60601; ISSO/IEC 80601; ABNT NBR IEC 60601; ABNT NBR 
ISO/IEC 80601. G/TBT/N/BRA/605 
 
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  9. Proposed date of adoption:   Upon publication in the Official Journal after subsequent 
discussions on consolidating the final text with the representatives of the sector and, received comments have been taken into account. 
Proposed date of entry into force:   Upon publication in the Official Journal after 
subsequent discussions on consolidating the final text with the representatives of the sector and, received comments have been taken into account. 
10. Final date for comments: 28 September 2014 
11. Texts available from: Nati onal enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body: 
http://www.inmetro.gov.br/legis lacao/rtac/pdf/RTAC002160.pdf