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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.
- Manufacturing medical devices: where to start
Regulatory requirements and processes that apply to manufacturing medical devices, including IVDs
- Guidance on certification audits for medical devices
The TGA performs audits of manufacturers of therapeutic goods
- Manufacture of medical devices: Quality management
It is the manufacturer's responsibility to demonstrate compliance with the Essential Principles for their medical devices
- System or procedure packs: Guidance for sponsors, manufacturers and charities
Regulatory requirements that apply to system or procedure packs, including those supplied using the special conformity assessment procedure
- First aid kits: Guidance for sponsors and manufacturers
Regulatory requirements that apply to first aid kits, which are regulated as system or procedure packs
- Personalised medical devices (including 3D-printed devices)
A new framework for regulating personalised medical devices commenced on February 25, 2021, and established a new definition of custom-made medical devices
- Manufacturer’s ongoing responsibilities
Manufacturers have ongoing legal obligations for medical devices that they manufacture that are supplied in Australia
- Guidelines for sterility testing of therapeutic goods
Guidance for manufacturers, the TGA and for referee testing when results are in dispute