Scheduling of medical devices
Information document no. 38
Sponsors are reminded that medical device products containing a substance scheduled in accordance with the recommendations of the National Drugs and Poisons Schedule Committee (NDPSC) must be appropriately labelled as required for the assigned schedule. Labelling requirements are set out in the Standard for Uniform Scheduling of Drugs and Poisons (SUSDP) <http://www.tga.gov.au/ndpsc/susdp.htm>.
Scheduling is controlled at State/Territory level in the relevant Drugs and Poisons legislation which adopt the recommendations of the SUSDP. It is the sponsor's responsibility to ensure that the product complies with the relevant labelling requirements.
Examples of some device products currently subject to scheduling are:
- Injectable hyaluronic acid (S4 only) - viscoelastics for eye surgery, synovial joint fluid replacement, tissue augmentation
- Injectable collagen (S4 only) - tissue augmentation, tissue scaffolds (implanted), coatings (implanted)
- Injectable polysulfated glycosaminoglycans (S4 only) - viscoelastics for eye surgery, synovial fluid replacement
- Injectable silicones (S4) - tissue augmentation, eye surgery
- Glutaraldehyde for human therapeutic use (S2, S5 or S6) - disinfectants/sterilants, tissue glues (external and internal)
- Gentamicin sulfate (S4 only) - anti-bacterial coating of implants
- Lignocaine (S2 or S4) - analgesic applied to some temporary implants/diagnostic aids
- Heparin for internal use (S4) - blood collection and processing equipment
Sponsors should note that entries in the SUSDP refer to all salts and derivatives of the substance unless specifically exempted.
Where a product contains a new chemical entity, ie one that is not already listed on the Australian Register of Therapeutic Goods (ARTG) <http://www.tga.gov.au/docs/html/artg.htm> or the Australian Inventory of Chemical Substances (AICS) <http://www.nicnas.gov.au/industry/AICS.asp>, consideration by the NDPSC of Poisons Schedule requirements is unlikely to have occurred previously. Chemicals on the AICS but which are being used for the first time as ingredients in a product for domestic use, are also unlikely to have been previously considered by the NDPSC. For disinfectant products containing a new chemical entity, referral to NDPSC, where appropriate, will be done in conjunction with the toxicology evaluation. New disinfectant actives will routinely be referred to the NDPSC for consideration but new and existing excipients will only be referred where the hazard profile of the chemical is consistent with the NDPSC guidelines for inclusion in the various Poisons Schedules. For other products, the decision may be separate from the evaluation process, and interim labelling may be required, pending the decision of the NDPSC.