Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020
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4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) health practitioner;
(b) included in the Register;
(c) medical device;
(d) Register;
(e) sponsor; and
(f) supply.
In this instrument:
Act means the Therapeutic Goods Act 1989.
SAS Guidance means the document titled Special Access Scheme Guidance for health practitioners and sponsors (Version 1.1, September 2017) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.
Note: The SAS Guidance is published at www.tga.gov.au.
Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.