Type of Notification
regular notification
Date of Distribution
2014.06.03
WTO Country
Agency Responsible
ANVISA – Brazilian Health Surveillance Agency
Regions Affected
National Institute of Metrology, Quality and Technology - INMETRO Telephone: +55 (21) 2563.2840 Telefax: +55 (21) 2563.5637 Email: barreirastecnicas@inmetro.gov.br Website: www.inmetro.gov.br/barreirastecnicas
Notified Document Details
Draft Resolution nº 23, May 13th 2014, that disposes about in vitro diagnosis products. (19 pages, in Portuguese).
Product
ICS Code
Covered Products
In vitro diagnosis products
Description of Content

This draft Resolution establishes the necessary requirements to register, cancel, alter and revalidate in vitro diagnosis products.

This draft resolution applies to products which are manufactured or imported to Brazil and which are classified according to some risk criteria and its goals.

According to this draft technical regulation, the registration, alteration, revalidation and cancellation of the registration of these products are made under de presentation of some general and documental requirements.

For purposes of regularization of the products at Anvisa, IVD products are classified under the following classes:

I - Class I: low-risk products to individuals and low risk to public health;

II - Class II: products of medium risk to individuals and / or low risk to public health;

III - Class III: high-risk products to individuals and / or medium risk to public health; and

IV - Class IV: high-risk products to individuals and high risk to public health.

According to the risk classification of the IVD product, it will have different requirements to be regularized at Anvisa, as expressed in articles 18, 19 and 20 of the draft technical regulation.

Objectives & Rationale
Protection of human health or Safety
Relevant Documents

Brazilian Official Journal (Diário Oficial da União), May 20th   2014; Section 1, p. 36, Draft Resolution (Consulta Pública) number 23, May 13th 2014, issued by Brazilian Health Surveillance Agency – Anvisa. When adopted, it will be published at the Brazilian Official Journal. Available in Portuguese.

Final Date of Comments
2014.07.25
Contact Details
Agency responsible Brazilian Health Surveillance Agency – ANVISA SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil CEP: 71.205-050 Phone.: +55 (61) 3462-5402 E-mail: rel@anvisa.gov.br Web http://portal.anvisa.gov.br/wps/wcm/connect/da2b6180441149408452be94043333b2/consulta+p%C3%BAblica+n%C2%B0+23+GGTPS.pdf?MOD=AJPERES
Document Online Link (EN)
Notified Under
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