Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
Labelling and patients

Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 direct-marking: Directly mark reusable devices

What does direct-marking require?

For a model intended by the manufacturer to be reprocessed between patients, the manufacturer must directly mark the device identifier and the production identifier. The mark must be in both human and machine readable form, or in one form where both are impracticable or inappropriate. The duty does not apply to devices made before the direct marking start day, implantable devices, devices where marking is likely to affect safety, performance or effectiveness, or where marking is impracticable.

Maintained by Gerard Blokdyk

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