NEWS AND PUBLICATIONS

New rules from ANVISA – National Agency of Sanitary Vigilance on labelling requirements

by | Oct 5, 2022 | Client Alert, Life Sciences

On September 15, 2022, the Federal Register published Resolution 751, which deals with risk classification, notification and registration regimes, and the labelling requirements and instructions for the use of medical devices.

This resolution will come into force on March 1, so there is enough time for the productive sector to promote the necessary changes. It addresses issues such as scope, definitions, medical device risk classification, application rules and classification, procedures for notifying or registering medical devices, alteration or modification thereof, revalidation of medical device registrations, information compliance, medical device document repository, procedural reassessment, and administrative sanctions, among others.

Related

Uruguai joins the PCT

We inform you that the House of Representatives of Uruguay approved the Patent Cooperation Treaty (PCT) on June 4, 2024. We emphasize that a reservation related to Chapter II: International Preliminary Examination was included. The next step is the analysis and voting...

read more

Subscribe to our newsletter

Consent