This section is for manufacturers of medical devices, including IVDs.
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.
Information on specific types of medical devices
- PageIn vitro diagnostic (IVD) medical devicesLinks to information on IVD medical devices, including HIV and nutrigenetic tests.
- GuidanceIn vitro fertilisation (IVF) solutionsHow to demonstrate that IVF solutions comply with the Essential Principles for safety and performance.
- PagePersonalised medical devicesLinks to information on personalised medical devices (including custom-made, patient-matched, and adaptable medical devices.
- PublicationsDevice-medicine boundary productsGuidance to assist sponsors determine the status of therapeutic goods that are not readily identified as medicines or medical devices.
- PagePersonal protective equipmentLinks to information on the regulation of personal protective equipment (PPE).
- PageSystem or procedure packsInformation for manufactures and sponsors of medical device systems or procedure packs.
- PublicationsRequirements for the assessment of medical devices containing animal materialGuidance to help sponsors understand regulatory requirements for medical devices containing animal material.
- TopicUnique Device Identification (UDI) HubThe UDI system will allow tracking and tracing of medical devices, including those that have been implanted in patients.