The National Health Surveillance Agency (“ANVISA”) has published two Public Consultations (“CPs”) dealing with risk classification, registration, labeling and instructions for use of medical devices.
• CP No. 730/2019, which provides for medical device risk classification rules and procedures for registration, alteration, revalidation and cancelation of the marketing authorization of medical devices classified as risk classes III and IV, has been proposed to update the current ANVISA Resolution No. 185/2001. CP No. 730/2019 does not apply to in vitro diagnostic medical devices, which is being proposed by CP No. 734/2019.
• CP No. 734/2019, in turn, proposes to update ANVISA’s Resolution No. 36/2015, which establishes the risk classification, regimen of notification, registration, marketing authorization, labeling requirements and instructions of use of in vitro diagnostic medical devices.
Both CPs will receive contributions from the general public, entities, and the regulated sector by 12/30/2019. Following such date, ANVISA will conduct an analysis of the received contributions and may promote further debate over the matter if necessary to qualify a decision by the Agency’s Board of Directors to approve the proposed text of the CPs and convert them into enforceable Resolutions.
The texts proposed by the CPs and forms for submission of contributions can be accessed through the following links: CP No. 730/2019 and CP No. 734/2019.
Our Life Sciences team is available to provide their clients with any assistance on the subject.