ANVISA published last December three Guides from the International Medical Device Regulators Forum (IMDRF), related to the scenario of clinical evaluation of medical devices in Brazil.

The Guides express ANVISA’s understanding of best practices regarding procedures, routines and methods deemed appropriate to meet technical or administrative requirements by the Agency’s legislative and regulatory frameworks regarding clinical evaluation.

– They are non-normative regulatory instruments, of a non-binding and advisory nature –

Therefore, it is possible to use alternative approaches to the propositions set forth, provided they are compatible with the requirements related to the specific case. Failure to comply with the contents of the documents does not characterize a sanitary infraction, nor does it constitute grounds for rejecting petitions, provided that the requirements of the law are met.

The first Guide, which is titled Medical Device Clinical Evidence Guide – Concepts and Definitions, aims to provide information to assist in building clinical evidence to support the safety and efficacy of medical devices. The second Guide, which is titled Medical Device Clinical Investigation Guide, aims to provide information to assist in the design and conduct of clinical investigations. While the  third document, Clinical Medical Device Evaluation Guide, aims to provide information to assist in outlining the clinical evaluation of medical devices.

The recommendations contained in the Guides take effect from the date of their publication on the ANVISA Portal, but are open to receive suggestions from the company through an electronic form, available at:

https://pesquisa.anvisa.gov.br/index.php/22341?lang=pt-BR (Portuguese only).

Contributions received will be evaluated and may support the revision of the Guides and the consequent publication of a new version of the documents.

The documents were built from a working group within IMDRF, the world’s largest forum for medical device regulators. Through the implementation of them, ANVISA seeks to provide more accurate and deeply harmonized guidance on the regulatory guidelines that establish the need for proving the safety and efficacy of medical devices for registration in Brazil.

Join DOMO in reviewing and contributing with ANVISA! Our team is available to answer any questions regarding the Guides.

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DOMO Salute Team