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Insights into the Practical Implications for Medical Device Clinical Investigation requirements in Brazil
Date: 01/05/2024
Collegiate Board Resolution (RDC) 837/2023, published by ANVISA on December 15th, 2023, brings updates to the rules regarding clinical investigations with medical devices performed in Brazil. Effective immediately from the publication, this resolution aligns Brazilian practices with international standards, providing clearer guidelines for clinical investigations subject to submission to the Agency.
One of the significant changes brought about by the new RDC is the consolidation of information to be submitted to ANVISA, eliminating the need for the submission of two separate dossiers for the study approval process. Now, all documentation related to the medical device and the clinical investigation plan will be submitted under a single dossier process known as the Clinical Investigation Dossier for Medical Devices (DICD), streamlining the analysis.
In terms of ANVISA’s approval scope, starting from the effective date, only clinical investigations with results that may support the registration of Risk Class III and IV medical devices in Brazil will be eligible for submission to the Agency. Consequently, the regulation eliminates the need to submit post-commercialization studies and those related to Risk Class I and II medical devices for ANVISA’s prior approval.
The regulatory update also adopts a more convergent terminology, harmonizing with RDC 751/2022 regarding the development of medical devices. Additionally, it eliminates the requirement for the detailed opinion of the Research Ethics Committee (CEP) from the list of documents for the initial submission of clinical research with medical devices.
Concerning the importation of medical devices exclusively for clinical trials in Brazil, the regulation specifies that importations are subject to analysis and approval by the health authority through the SISCOMEX (Integrated Foreign Trade System) platform, which makes import-related processes more efficient and standardized.
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*Article based on ANVISA’s publication, available here.