Australia Therapeutic Goods (Medical Devices) Regulations 2002 r7.6-7.8: Authorised prescribers: supply under an authority only as its directions allow, and when a health practitioner supplies a device under the authorised prescriber scheme notify the patient initials, condition, intended use, product, manufacturer, practitioner and practice details

What does r7.6-7.8 require?

A specialist authorised to supply an unapproved device under section 41HC of the Act must be endorsed by a hospital ethics committee, or for practice outside hospital an ethics committee with relevant expertise or geographic coverage (or, in exceptional cases, a specialist college with relevant expertise or none available), and recipients must have a life-threatening or otherwise serious condition. The supplier must follow the directions in the authority for the therapeutic intervention. A notification of a supply by a health practitioner under section 41HC(6B) must give the person's initials, date of birth and gender, each condition and intended use, the device's product name, manufacturer and description including any variant, the practitioner's name, AHPRA number, contact details, profession and principal place of practice.