Secretary may require information relating to approvals under section 41HD
41JFA Secretary may require information relating to approvals under section 41HD
The Secretary may give to a person who is granted an approval under subsection 41HD(1), (1A) or (2) in relation to a medical device a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:
the supply of the medical device;
the handling of the medical device;
the monitoring of the supply of the medical device;
the results of the supply of the medical device;
any other matter prescribed by the regulations for the purposes of this paragraph in relation to the kind of medical device that includes the medical device.
The notice must specify a reasonable period within which the person must comply. The period must be at least 10 working days starting on the day on which the notice is given.
The notice may require information to be given in accordance with specified software requirements:
on a specified kind of data processing device; or
by way of a specified kind of electronic transmission.
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
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