Secretary may require information etc. about medical devices exempt under Part 4‑6A
41JCA Secretary may require information etc. about medical devices exempt under Part 4‑6A
This section applies to a person who is required to comply with a condition of an exemption of a kind of medical device under section 41GS.
The Secretary may, by written notice given to the person, require the person to give to the Secretary specified information or documents relating to one or more of the following:
the supply of devices of that kind;
the handling of devices of that kind;
the monitoring of the supply of devices of that kind;
the results of the supply of devices of that kind;
any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of that kind.
The notice must specify a reasonable period within which the person to whom the notice is given 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
4 more instruments made under this Act are listed on the Act’s overview.
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