Manufacturing medical devices and 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.

Device labels must include the manufacturer's name and address.

• Manufacturing medical devices: where to start
  Regulatory requirements and processes that apply to manufacturing medical devices, including IVDs.
• System or procedure packs
  System or procedure packs that are subject to regulatory requirements
• First aid kits that contain medical devices and/or medicines
  Regulatory requirements that apply to first aid kits.
• Personalised medical devices (including 3D-printed devices) 
  Information and examples to understand the regulatory framework for personalised medical devices. 
• Post market responsibilities for manufacturers and sponsors of medical devices
  Start here to learn the basics of post market requirements. 
• Sterility testing of therapeutic goods
  Guidelines for sterility testing of medical devices supplied in Australia for human use.