The Brazilian Health Regulatory Agency (ANVISA) enacted three normative acts for the economic oversight of selected medical devices. ANVISA seeks to mitigate information discrepancies in the medical devices market.
The Brazilian Health Regulatory Agency (ANVISA) enacted a new regulatory framework for the economic oversight of selected medical devices, designed to mitigate information discrepancies in the medical devices market, providing adequate price monitoring. The regulatory framework is comprised of:
- RDC Resolution n. 478/2021: provides the economic monitoring of medical devices;
- Normative Instruction n. 84/2021: lists 13 medical devices selected for ANVISA economic monitoring;
- Normative Instruction n. 85/2021: lists the technical attributes of the selected medical devices.
Articles 20 and 21 of the new resolution provide the required procedures for submitting product information to ANVISA, applicable to companies that seek new medical device registrations or that have previously registered a medical device. The new framework revoked RDC Resolution n. 185/2006. Further information on medical device registration can be found at ANVISA’s website.
