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Manufacturing medical devices & IVDs

This section is for manufacturers of medical devices, including IVDs. You should also see Manufacturing basics, which includes information for manufacturers of all types of therapeutic goods.

Manufacturers take full responsibility for the design and production of a medical device, whether they make the device themselves or subcontract some of these activities. The name and address of the manufacturer must be provided on the device label.

If you have an enquiry about medical devices that is not answered by this website, please see the contact details for enquiries about medical devices, including IVDs.