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 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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