When conformity assessment certificates are required
41EA When conformity assessment certificates are required
The regulations may prescribe:
kinds of manufacturers in respect of whom a conformity assessment certificate must be issued before valid applications can be made for kinds of medical devices, manufactured by those manufacturers, to be included in the Register; or
kinds of medical devices in respect of which a conformity assessment certificate must be issued before valid applications can be made for those kinds of medical devices to be included in the Register.
The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices: see subsection 41LA(2).
This provision refers to the regulations (The regulations may prescribe
). 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.
This Act’s bill:Second reading speech
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