Regulatory Update

ANVISA's Collegiate Board Meeting Opens to Public Participation

ANVISA's DICOL Discusses Essential Medical Device Regulations, Enhancing Safety and Regulatory Convergence in Brazil.

Published on:
March 1, 2024

On March 6, 2024, ANVISA held DICOL, which are meetings of the Collegiate Board (Dicol) of the National Health Surveillance Agency (Anvisa) that occur periodically and are open to society's participation.

At the DICOL meetings, there are several deliberative matters regarding ANVISA's 2024-2025 regulatory agenda, as well as decisions on some regulatory processes.

In this last meeting (03/06/2024), important regulatory topics focused on the area of medical devices were discussed. They are:

1) Approval of the revision text of the essential safety and performance requirements for medical devices and medical devices for in vitro diagnostics, in yet another regulation aligned with a document issued by IMDRF, maintaining our commitment to regulatory convergence.

Pure Global’s Regulatory Expert:  Super relevant - Reliance topic in which ANVISA has been committed and, which will bring more and more business to Brazil. (RDC 741:2022)

2) Approval of the Proposal to Open an Administrative Regulation Process to restrict the use of dental amalgam in pregnant women, breastfeeding women, and in primary dentition in individuals up to 15 years of age in health services, in line with what is established in the Minamata Convention.

Pure Global’s Regulatory Expert: ANVISA is always concerned with patient safety.

3) Approval of the Proposals for the Single Opening of the Administrative Regulation Process and Normative Instruction to update the list of Technical Standards for the certification of equipment under the health surveillance regime, within the scope of the Brazilian Conformity Assessment System (SBAC).

Pure Global’s Regulatory Expert: De-bureaucratization of the regulatory process in Brazil.

4) Approval of the proposal for extraordinary, emergency, and temporary prioritization of the analysis of petitions for registration of medical devices for in vitro diagnosis for Dengue, which is an important contribution from Anvisa in the joint strategy with the MS to expand the arsenal for diagnosis and combating Dengue Dengue.

Pure Global’s Regulatory Expert:  Excellent theme for attracting IVD medical devices to Brazil.


Furthermore, the issues above are linked to ANVISA's regulatory agenda 2024-2025, below are the topics to be addressed in the regulatory agenda:

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