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: (1) validation of cleaning and sterilization procedures with documented efficacy studies, (2) documented quality management systems compliant with ISO 13485, (3) full traceability of reprocessed devices (serial numbers linked to original device records), (4) post-reprocessing performance testing confirming devices meet original specifications, and (5) periodic audits and adverse event reporting to ANVISA. Reprocessors must also obtain a specific ANVISA operating authorization separate from device registration.
Prohibited Reprocessing Categories: ANVISA RDC 156/2006 prohibits reprocessing of: (1) devices with labels or sterilization claims dependent on single use, (2) devices designed to contact blood or blood products (e.g., blood bags, needles for blood draw), (3) devices with complex internal lumens that cannot be reliably cleaned and sterilized (e.g., some catheters with intricate pathways), (4) implantable devices, (5) devices with adhesive coatings or materials that degrade during reprocessing, and (6) devices with tamper-evident or integrity-dependent seals.
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.