Single-Use Devices — Reprocessing Rules
ANVISA's RDC 156/2006 (and updates) established a framework for reprocessing of single-use devices. Brazil permits limited reprocessing under strict conditions by ANVISA-authorised reprocessors only.
Devices labelled "single use" (uso único) may only be reprocessed by an ANVISA-authorised reprocessor who demonstrates that reprocessed devices meet the same safety and performance standards as new devices. Certain device categories are prohibited from reprocessing — including devices that contact blood, devices with complex lumens, and high-risk implants.
Manufacturers must state "uso único" or "não reprocessar" clearly on the label.
Verify all information against official ANVISA sources before making regulatory decisions.
ANVISA-authorised reprocessors must demonstrate: validation of cleaning and sterilization procedures, documented quality management systems (ISO 13485), traceability of reprocessed devices, and post-reprocessing performance testing. Reprocessors must also obtain a specific ANVISA operating authorization separate from device registration.