ANVISA published today (September 18th) the Resolution 423/2020 which establishes that Risk Class II medical devices that were previously under the CADASTRO regime, will be now taking the NOTIFICATION route.

Last year (March 1st) ANVISA had established the NOTIFICATION route for Risk Class I devices through RDC 270/2019. Under the new Resolution, risk classes I and II will undergo a simplified process that does not require ANVISA to technically analyze the device prior to granting the registration.

The changes in the regulation have no impact on the productive sector, since there will be no changes in the way petitions are applied, nor in the necessary documentation. Since NOTIFICATION processes take up to 30 days after the application, RDC 423/2020’s publication will allow greater balance and agility in the analysis of products with higher risk, as well as less time for products with lower risk to reach the Brazilian market.

As previously mentioned, the documentation required and the technical requirements for Risk Class II products remain the same. However, it is important that companies are attentive to possible requests for additional information in cases of processes that undergo documentary audit or procedural review. In these cases, ANVISA will send communications directly to the companies, establishing a deadline for them to reply.

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DOMO Salute Team