G/TBT/N/BRA/785  
 
16 January 2018  
(18-0422) Page: 1/3 
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   
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=33294  
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): Goods and 
products subject to Sanitary Surveillance  
5. Title, number of pages and language(s) of the notified document: Resolution - RDC 
Nº 208 – Simplification of procedures for the important of goods and products subject to 
Sanitary Surveillance, January 5th, 2018. (25 page(s), in Portuguese )   
6. Description of content: This Resolution establishes the simplification of procedures for 
the importation of goods and products subject to Sanitary Surveillance.  
This Resolution amends the Resolutions of the Collegiate Board of Directors - RDC nº 46  of 
18 May 2000, nº 81 of 5 November 2008, nº 58 of 17 December 2010, nº 68 of 28 March 
2003 and nº 204 of 6 July 2005, aimed at simplifying procedures for the importation of 
goods and products subject to sanitary surveillance  
This Resolution changes the a rt. 3; includes in item 1.2 of Chapter II the sub -item 1.2.1.; 
changes item 3.5 of Subsection II of Section I of Chapter III; changes item 5 of Subsection 
II of Section I of Chapter III; changes item 7 of Chapter VII; changes item 1 of Chapter 
IX; changes subitem 1.1 of Chapter IX; changes subitem 3.1 of Chapter IX; changes 
Chapter XV; changes Chapter XVIII; changes item 1 of Chapter XX; changes subitem 1.3.1 
of Chapter XX; changes item 1.4 of Chapter XX; changes Chapter XXI; changes Chapter 
XXVI; changes C hapter XXVIII; changes item 6 of Section II of Chapter XXX; changes item 
10 of Section IV of Chapter XXX; changes Chapter XXXII; changes Chapter XXXIV; 
changes item 2 of Chapter XXXVII; changes the title of Section I of Chapter XXXIX; 
changes items 25 and 26 of Section VI of CHAPTER XXXIX; changes the title of Section VII 
of CHAPTER XXXIX; changes item 29 of Section VII of CHAPTER XXXIX; changes item 33 
of Section VIII of CHAPTER XXXIX; changes section 36 of Section VIII of CHAPTER XXXIX; 
changes section 57  of Section X of CHAPTER XXXIX of the Resolution of the Collegiate 
Board of Directors - RDC nº 81, of 2008.  G/TBT/N/BRA/785  
 
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  This Resolution changes the Paragraph 2 of art. 6 of the Resolution of the Collegiate Board 
of Directors - RDC nº 204, of 6 July 2005; changes the a rt. 17 of the Resolution of the 
Collegiate Board of Directors - RDC nº 58, of 17 December 2010; changes the caput and 
paragraph 2 of art. 18 of the Resolution of the Collegiate Board of Directors - RDC nº 58, 
of 2010.  
This Resolution revokes the following provisions of the Resolution of the Collegiate Board of 
Directors - RDC n ° 81, of 5 November 2008: item 3.4 of Subsection II of Section I of 
Chapter III; item 5.4 of Section IV of Chapter XVIII; subitems 2.1 and 2.1.1 of Chapter 
XXIV; Chapter XXIX; item 2 , subitems 6.2 and 10.2 of Chapter XXX; Chapter XXXV; item 
11, subitems 11.1 and 11.2 of Chapter XXXVII.  
This Resolution revokes the following provisions of Chapter XXXIX of the Resolution of the 
Collegiate Board of Directors - RDC n. 81, of 5 November 200 8: item 3, items 4, 
subparagraphs b, c, h, l, subitems 4.1, 4.2 and item 5, of Section I; subparagraphs b, c, h, 
j, l of item 10, subitems 10.1, 10.2 and item 11 of Section II; subparagraphs b, c, f, i, j of 
item 16 of Section III; items 13, subitems 13.1,  13.2, 13.3 and item 14 of Section III; 
item 17, subparagraphs b, c, f, i, j, l of item 18, subitems 18.1, 18.2, 18.3 and item 19 of 
Section IV; items b, c, f, h, i of item 22, subitems 22.1, 22.2, 22.3 and item 23 of Section 
V; subitems 25.1, 25.2, 25.3, 26.1, 26.2, 26.3 and item 27 of Section VI; item 30, 
subitem 30.1, subparagraphs b, c, d, g, i, j, l of item 31, subitems 31.1, 31.2, 31.3 and 
item 32 of section VII; item 34, subitem 34.1, item 35, subitems 35.1, 35.2, 35.3, 36.1, 
36.2, 36.3 and item 37 o f Section VIII; subparagraphs b, c, f, g, h, l, m of item 39, 
subitems 39.1, 39.2, 39.3 and item 40 of subsection I of Section IX; subparagraphs b, c, f, 
g, i and j of item 42, subitems 42.1, 42.2, 42.3 and item 43 of subsection II of Section IX; 
subparagr aphs b, c, f, h, j and l of item 45, subitems 45.1, 45.2, 45.3 and item 46 of 
subsection III of Section IX; subparagraphs b, c, f, g, i, j of item 49; subitems 49.1, 49.2, 
49.3, item 50 of Subsection IV of Section IX; subparagraphs b, c, f, g, j and l of i tem 52, 
subitems 52.1, 52.2, 52.3 and item 53 of subsection V of section IX; subparagraphs a, b, 
c, e, f of subitem 54.1, subparagraphs b, c, f, g, h, i of item 55, subitems 55.1, 55.2, item 
56 of subsection VI of Section IX; item 58, subitems 58.1 and 58. 2, subparagraphs b, c, f, 
g, h, j, l of item 59, subitems 59.1, 59.2 and 59.3, item 60 of Section X; subparagraphs b, 
c, f, j, l of item 65, sub items 65.1, 65.2, 65.3 and item 66 of Section XI.  
This Resolution revokes the art. 4 and Annex II of the Resolu tion of the Collegiate Board of 
Directors - RDC No. 46, of 18 May 2000; art. 19, 22 and 23 of the Resolution of the 
Collegiate Board of Directors - RDC nº 58, of 17 December 2010; the sole paragraph of 
art. 1, art. 4, art. 5 and art. 6 of the Resolution of  the Collegiate Board of Directors - RDC 
No. 68, 28 March 2003.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  Resolutions of the Collegiate Board of Directors - RDC nº 46 of 
18 May 2000; nº 81 of November 5, 2008; nº 58 of 17 December 2010; nº 68 of 28 March 
2003 and nº 204 of 6 July 2005.   
9. Proposed date of adoption: On the date of its publication.  
Proposed date of entry into force: On the date of its publication . 
10. Final date for comments: Not applicable  G/TBT/N/BRA/785  
 
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  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/10181/2957335/RDC_208_2018_.pdf/eccf9152 -
9aae-43d0-83b4-e2f6b3015425