Manufacturing medical devices & IVDs
This section is for manufacturers of medical devices and IVDs. You should also see Manufacturing basics and Manufacturing inspections, which include 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 always appears 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 medical devices enquiries.
- Manufacturing medical devices: where to start
Regulatory requirements and processes that apply to medical device manufacturing activities
- Guidance on certification audits for medical devices
The TGA performs inspections of Australian manufacturers of therapeutic goods
- Manufacture of medical devices: Quality management
Medical devices are expected to be of a high quality and quality management systems are required to be in place
- Systems or procedure packs: Declarations under Schedule 3 Part 7.5
Clarifies a number of issues which could be of relevance to some companies assembling procedure packs for supply in Australia
- Custom made medical devices
Manufacturing of custom made devices must, at a minimum, meet conformity assessment procedures
- What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
Depending on the classification of a device, there are a number of different conformity assessment procedures a manufacturer may use to demonstrate compliance with the Essential Principles
- Guidelines for sterility testing of therapeutic goods
Guidance for manufacturers, the TGA and for referee testing when results are in dispute