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TGA regulation of PRP procedures

In July 2018, the Australian Therapeutic Goods Administration (TGA) tightened regulation governing all blood products & biological materials and further legislation was introduced.

All Alocuro devices are listed on the TGA’s ARTG register as medical devices

All facets of Alocuro protocol meet the current TGA regulations and the PRP produced is ‘regulated as blood components but exempt from most regulation requirements’ when PRP procedures have medical practitioner oversight.

The PRP that Alocuro PRP system produces is therefore allowed to be performed outside of a hospital and advertised to the public because it meets all of the following criterion:

  • - Collected from a patient who is under the clinical care of a medical or dental practitioner registered under a law of a State or an internal Territory; and
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  • - Manufactured and used by the practitioner with primary responsibility for clinical care OR by a person or persons under the professional supervision of that practitioner; and
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  • - For a single indication in a single clinical procedure; (this means no freezing for later use)
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  • - Are minimally manipulated and for homologous use.

To note, at this time, it is medical practitioners only that can provide the ‘professional supervision’ requirement. TGA Biologicals department have advised that nurse practitioners do not fulfill the TGA legislated requirements for professional supervision of PRP procedures.

There is no restriction on advertising your PRP service when:

  1. 1. Using Alocuro PRP system to produce PRP
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  3. 2. PRP procedure is performed as ‘point-of-care
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  5. 3. Single clinical procedures (no biological material can be stored/frozen for later use)
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  7. 4. With medical or dental practitioner oversight, and they are trained in Alocuro PRP manufacture steps

Where one or more above criteria are not met, the exemptions from TGA regulatory requirements do not apply, and the product will be regulated as a ‘Biological’. This means the procedure cannot be performed unless the strict “Biological” regulations are met and the procedures cannot be advertised to the public.