G/TBT/N/BRA/1163  
22 April 2021  
(21-3446) 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 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.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):  
Provitamins and vitamins, natural or reproduced by synthesis, incl. natural concentrates, 
derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, 
whether or not in any solvent (HS 2936); Hormones, prostaglandins, thromboxanes and 
leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues 
thereof "incl. chain modified polypeptides", used pri marily as hormones (HS 2937); Dried 
glands and other organs for organo -therapeutic uses, whether or not powdered; extracts 
of glands or other organs or their secretions, for organo -therapeutic uses; heparin and 
its salts; other human or animal substances p repared for therapeutic or prophylactic uses, 
n.e.s (HS 3001); Human blood; animal blood prepared for therapeutic, prophylactic or 
diagnostic uses; antisera and other blood fractions and immunological products, whether 
or not modified or obtained by means of biotechnological processes; vaccines, toxins, 
cultures of micro -organisms (excl. yeasts) and similar products (HS 3002); Medicaments 
consisting of two or more constituents mixed together for therapeutic or prophylactic 
uses, not in measured doses or put  up for retail sale (excl. goods of heading 3002, 3005 
or 3006) (HS 3003); Medicaments consisting of mixed or unmixed products for 
therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal 
administration" or in forms or packin gs for retail sale (excl. goods of heading 3002, 3005 
or 3006) (HS 3004); Pharmaceutical preparations and products of subheadings 
3006.10.10 to 3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Public 
Consultation No . 1035, 8 April 2021. Comment form: 
https://pesquisa.anvisa.gov.br/index.php/512992?lang=pt -BR (10 page(s), in 
Portuguese)  
6. Description of content:  Public Consultation No. 1035 e stablishes technical requirements 
for the software regularization as a medical device.  G/TBT/N/BRA/1163  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Software used as medical devices and various medical equipment with 
software are n ot certifiable. Brazil does not have a regulated software certification process 
as a medical device, mainly due to the absence of an ABNT, IEC or ISO standard that 
allows its certification. However, there is a voluntary and private certification experience  
of the Brazilian Society of Health Informatics (SBIS) in partnership with the Federal 
Council of Medicine (CFM) for Electronic Health Registration Systems (SBIS). This type of 
software, despite belonging to the health area, does not automatically characte rize the 
need for regularization in Anvisa, according to Technical Note No. 
04/2012/GQUIP/GGTPS/ANVISA. Nevertheless, the above -mentioned regulations bring in 
their scope the software as a medical device (with the designation of software), some 
built-in requirements are impossible to be met by the software and other requirements 
subject to interpretation, which weakens its application. These requirements were 
designed for tangible (physical) goods. However, the software, unusual at the time, is 
intangible ( virtual). Thus, it is not conceived, for example, a software bringing indelible 
label or even labelling or printed manuals for software distributed over the Internet or by 
mobile applications or batch and series control, when it should have control by vers ioning. 
Other information essential for software, such as forms of updating, is not part of the 
sanitary requirement. There were also requests from the regulated sector and company 
with participation in the Internal Consultation and sector dialogues during  the construction 
of the regulatory agenda 2017 -2020, and its consequent inclusion in it. Another motivator 
is that the software has been the leader in recalls for 13 consecutive quarters at the FDA 
through the first quarter of 2020. As the distribution of  the software is global and virtual 
(e.g., Android and Apple app stores, Internet, etc.), it can infer that Brazil is suffering the 
same consequences. The following ranking positions refer to problems of labelling, quality 
and sterility. In addition, the s oftware as a medical device had discussions within the of 
the International Medical Device Regulators Forum (IMDRF), of which Brazil is part and 
harmonizes its regulations, resulting the creation of 5 guiding documents to the countries 
that are members of the forum to build their regulations. Therefore, it would be necessary 
to update the regulation. Finally, it was verified the need to adapt the regulation to the 
current health scenario, aiming, above all, to meet the new needs and demands of health 
care, modernization in regulation and scientific and technological advances in the sector. 
Thus, the objectives of this theme related to anvisa's strategy are: • Expand the safe 
access of the population to products and services subject to Health Surveillance; • 
Improve the regulatory framework in Health Surveillance; • Optimise premarket actions 
based on risk assessment sanitary care; • Improve regulatory cooperation and 
convergence actions within the international scenario.; Protection of human health or 
safety  
8. Relevant documents:   
01) Brazilian Official Gazette 65 -A on 08 April 2021, section 1, page 2 02) Impact 
Assessment Report (RIA)  
https://www.in.gov. br/web/dou/ -/consulta -publica -n-1.035 -de-8-de-abril-de-2021-
312902879  
http://antigo.anvisa.gov.br/documents/10181/5141677/Relatorio_de_Avaliacao_do_Im
pacto_Regulatorio.pdf/f1723fd2 -0936-4444-8e21-e2b3320cd3aa  
9. Proposed date of adoption:  Not applicable  
Proposed date of entry into force:  Not applicable  
10. Final date for comments:  15 June 2021  G/TBT/N/BRA/1163  
 
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  11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
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://antigo.anvisa.gov.br/documents/10181/5141677/Minuta+1035.pdf/0e13d4e6 -
942a-4662-a2b2-63b3e32c1147