Updates regarding Definitions, Classification, Registration Pathways, Labeling and Instructions for Use requirements for Medical Devices and IVD Medical Devices

ANVISA has opened in last October the Public Consultation 730/2019 to discuss with the community updating RDC 185/2001, the standard that drives medical device registration in Brazil. The main goal of the proposed new resolution is the modernization of the Brazilian legislation as well as the regulatory convergence regarding medical devices’ classification rules to match the criteria stated in the European Medical Devices Regulation (MDR).

It was also published by ANVISA the Public Consultation 734/2019 which aims to discuss updates for RDC 36/2015, legislation related to IVDs registration, and it is also focused on regulatory convergence with international rules of classification.

DOMO experts prepared highlights concerning the changes being proposed in comparison to the current regulation (RDC 185/2001 and 36/2015):

• Stock depletion allowance to enable manufacturers selling previous versions of certain devices up to these products’ expiration dates, concomitantly with the commercialization of the new version.
• Provision for registration cancellation by ANVISA in case of cancellation proof of any of the documents that instructed the product’s regulation process.
• Provision for increased cooperation between MERCOSUR States Parties’ competent health authorities, so that an authority canceling or suspending medical devices registration must communicate the decision to other authorities, presenting technical justification.
• Inclusion of new definition terms in the legislation glossary, such as: cluster, aggregate, nanomaterial, particle, software as a Medical Device (SaMD), expansion of the definition of IVD Medical Devices.
• Updating existing risk classification rules and adding new rules, such as adding a software-specific rule and a device including nanomaterials-specific rule.
• Update of the Risk Class III and IV’s petition form (Annex IIIA).

ANVISA will accept comments on the new consultations for a 60-day period from their publication (up to the end of December).

We believe that the modernization of the legislations governing the registration of medical devices in Brazil is of paramount importance to keep ANVISA’s guidelines in line with worldwide guidelines. An effective participation and the inputs from the community are important mechanisms for the Agency to know the point of view of the regulated sector and help in building this new regulatory instrument.

Join in!

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute team