Essential principles
41CA Essential principles
The regulations may set out requirements for medical devices.
These requirements are to be known as the essential principles.
Regulations made for the purposes of subsection (1) may include requirements in relation to the inclusion in the database referred to in section 41CE of the following:
unique device identifiers of medical devices;
information relating to those unique device identifiers, those medical devices or the import, export, manufacture or supply of those medical devices.
Subsection (3) has effect subject to subsection 41CE(2).
Subsection (3) does not limit subsection (1).
This provision refers to the regulations (The regulations may set
). Made under this Act:
- Therapeutic Goods (Medical Devices) Regulations 2002 · under s 63
- Therapeutic Goods Regulations 1990 · under s 63
5 more instruments made under this Act are listed on the Act’s overview.
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