Single-Use Devices — Reprocessing Rules

BR-unique

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.

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.