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Custom-made medical devices
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Custom-made medical devices

Custom-made medical devices
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Under Regulation 10.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 you are required to notify the TGA of specific details if you are: the Australian manufacturer of a custom-made medical device, or an Australian sponsor (supplier) of a custom-made medical device that was manufactured overseas.
Notification is required within two months of manufacture or initial supply of the custom-made medical device. These forms are provided for your convenience to simplify this notification process.
I am the: *

Manufacturer

The classification rules can be found on the legislation.gov.au website.

Sponsor

The classification rules can be found on the legislation.gov.au website.
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