Content of Australian conformity assessment body certificates
41EWB Content of Australian conformity assessment body certificates
An Australian conformity assessment body certificate that is issued to a manufacturer of medical devices must specify whether it covers:
all medical devices manufactured by the manufacturer; or
only specified medical devices manufactured by the manufacturer.
An Australian conformity assessment body certificate must contain any other information prescribed by the regulations for the purposes of this subsection.
An Australian conformity assessment body certificate may be subject to conditions specified in the certificate.
This provision refers to the regulations (prescribed by the regulations
). 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
The statute text is free to read above. View subscription options to unlock the case-law research tools for each provision.