ANVISA Accepting Public Comments for New Medical Device Grouping Criteria

Medical device manufacturers interested in submitting comments to Brazilian regulator ANVISA regarding proposed new grouping criteria have until May 8 to do so.

The regulator began soliciting public comments April 8 on specific criteria for grouping health supplies into families for registration and cadastre purposes. The proposed rules are available on ANVISA’s website (Portuguese only).

Interested parties may email comments to tecnologia.produtos@anvisa.gov.br with the subject line “Specific Requirements for Grouping Health Supplies in Families for Registration and Cadastre.” Firms can also fax comments to +1.61.3448.1058, or send written comments to the following address:

 

National Health Surveillance Agency
General Management of Technology Products for Health
SEPN 515, Bloco B, Ed Omega
Asa Norte, Brazil 70770-502

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