Proposals dealing with risk classification, registration, labeling and instructions for use of medical devices will receive contributions from 10/30.
The Public Consultations (CPs) 730 and 734, on risk classification, registration, labeling and instructions for use of medical devices, will be open from Wednesday (30/10) for comments and suggestions.
CP 730 specifically addresses the proposed update of RDC 185/2001, which provides for the risk classification, registration regime, labeling requirements and instructions for use of medical devices. CP 734 refers to the update of RDC 36/2015, which establishes the risk classification, notification, registration and registration control regimes and labeling requirements and instructions for use of in vitro diagnostic medical devices and their instruments. .
Published in the Official Gazette (DOU) of October 23, CPs will receive contributions for 60 days. The submission of proposals for normative acts to public consultation aims to broadly validate a draft regulatory instrument and, at the same time, collect subsidies to qualify Anvisa's regulatory decisions. In other words, public consultations offer citizens, social entities and representatives of the regulated sector the opportunity to participate in the construction of regulatory standards.
How to participate?
After reading and evaluating the texts, suggestions may be sent by filling in a specific form, according to the respective CP:
CP 730 form on proposed update of RDC 185/2001 avaiable in: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=50936
CP 734 form on proposed update of RDC 36/2015 avaiable in: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=51499
At the end of the form, the registration number of the registration will be available. All contributions received are considered public and will be available in the "result" menu of the electronic form, including during the consultation process.
After the end of the CPs, Anvisa will analyze the contributions and may, if appropriate, promote discussions with organs, entities and those who have expressed interest in the matter, in order to provide further input for technical discussions and deliberation. end of the Collegiate Board.
Citizens who do not have internet access can also participate. In this case, contributions should be sent in writing, during the consultation period, to the following address: Anvisa / General Management of Health Products Technology (GGTPS), SIA, Excerpt 5, Special Area 57, Brasília-DF, CEP 71,205-050. Exceptionally, international contributions may be sent, in physical media, to the same address, but directed specifically to the Office of International Affairs (Ainte).