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 24, May 13th 2014, that defines the requirements for registration at Anvisa of low and medium risk medical devices for sanitary control. (10 pages, in Portuguese).
Product
ICS Code
Covered Products
Medical devices
Description of Content

This draft Resolution establishes the requirements for registration at Anvisa of low and medium  risk medical devices for sanitary control.

This draft Resolution applies to medical devices classified as Class Risk I and II.

According to this draft technical regulation, to request the registration of medical devices classified as Class Risk I and II and its alteration, the manufacturer or the importer must present a list of specific documents.  

The technical dossier, containing all documents and information, must be regularly updated by the national manufacturer or the importer to Anvisa.  

According to this draft technical regulation, the medical devices Class Risk I and II registered at Anvisa are exempt from revalidation. They must observe GMP, technical standards and specific standards, according the Brazilian System of Conformity Assessment – SBAC, when applicable, as expressed in Article 10 of the draft technical regulation.

Relevant Documents

Brazilian Official Journal (Diário Oficial da União), May 20th   2014; Section 1, p. 36, Draft Resolution (Consulta Pública) number 24, 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 http://portal.anvisa.gov.br/wps/wcm/connect/8df5d3804411512f846dbe94043333b2/Consulta+P%C3%BAblica+n%C2%B0+24+GGTPS.pdf?MOD=AJPERES
Document Online Link (EN)
Notified Under
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