Brazil - Draft Resolution 1423, September 23, 2026 on Single-Use and Reusable Medical Devices

The Brazilian Health Regulatory Agency (ANVISA) has published Draft Resolution No. 1423 of 23 September 2026 on Single-Use and Reusable Medical Devices, proposing requirements for the classification and regulatory approval of medical devices as either single-use or reusable. The proposed regulation does not apply to in vitro diagnostic devices or medical device software.

The proposal sets out labelling and instructions-for-use requirements, prohibits the reuse of designated high-risk devices and devices used in certain high-risk situations, and imposes restrictions on the importation and sale of used or reprocessed medical devices. 

The prohibited categories include implants, devices exposed to cytotoxic drugs or radiopharmaceuticals, and devices used on patients suspected of having Creutzfeldt-Jakob disease (CJD).​