Type of Notification
regular notification
Date of Distribution
2018.07.23
WTO Country
Agency Responsible
Brazilian Health Regulatory Agency (Anvisa)
Regions Affected
National Institute of Metrology, Quality and Technology (INMETRO) Telephone: +(55) 21 2563.2817 Telefax: +(55) 21 2563.5637 Email: barreirastecnicas@inmetro.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
Notified Document Details
<p style="margin:2px !important;">Draft Resolution Nº 540, 10 July 2018 (3 page(s), in Portuguese) Published in the Official Journal Number 134, 13 July 2018; Section 1 page 80</p>
ICS Code
Covered Products
<p style="margin:2px !important;">In vitro diagnosis products</p>
Description of Content

This Draft Resolution 540/2018 changes Normative Instruction nº 03, 26 August 2015, notified under the document G/TBT/N/BRA/590/Add.1, establishing the permission to group in vitro diagnosis products into systems.

The Draft Resolution Nº 540, 10 July 2018 is available at http://portal.anvisa.gov.br/documents/10181/4379139/Minuta+de+Consulta+P%C3%BAblica.pdf/5543de17-1531-4171-b65f-b19694bac245

Objectives & Rationale
<p style="margin:2px !important;"><span lang="EN-GB" style="mso-ansi-language: EN-GB; mso-fareast-language: EN-US; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: Calibri; mso-bidi-font-family: 'Times New Roman'; mso-bidi-language: AR-SA;">Protection of human health or safety</span></p>
Relevant Documents

Normative Instruction nº 03, 26 August 2015, Published in the Official Journal Number 164, 27 August 2015; Section 1, page 49 and notified under the document G/TBT/N/BRA/590/Add.1

(Normative Instruction nº 03 is available at http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=27/08/2015&jornal=1&pagina=49&totalArquivos=96)

Final Date of Comments
2018.08.19
Contact Details
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: http://portal.anvisa.gov.br/english
Document Online Link (EN)
Notified Under
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