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Manufacture of medical devices: Quality management
As with all therapeutic goods, medical devices are expected to be of a high quality. Quality management systems are required to be in place.
More information is available to assist sponsors and manufacturers understand the regulatory requirements for medical devices in Australia in the Australian Regulatory Guidelines for Medical Devices (ARGMD).
The Essential Principles
It is the manufacturer's responsibility to demonstrate compliance with the Essential Principles for their medical devices.
Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 set out 15 Essential Principles with which manufacturers must comply. There are six general Essential Principles that apply to all devices and nine further Essential Principles.
General Essential Principles
These six general Essential Principles apply to all devices:
- use of medical devices not to compromise health and safety
- design and construction of medical devices to conform to safety principles
- medical devices to be suitable for intended purpose
- long-term safety
- medical devices not to be adversely affected by transport or storage
- benefits of medical devices to outweigh any side effects.
Design and construction Essential Principles
There are a further nine Essential Principles about design and construction that apply to devices on a case-by-case basis:
- chemical, physical and biological properties
- infection and microbial contamination
- construction and environmental properties
- medical devices with a measuring function
- protection against radiation
- medical devices connected to or equipped with an energy source
- information to be provided with medical devices
- clinical evidence
- principles applying to IVD medical devices only.
Conformity assessment of a medical device
Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device complies with the Essential Principles. They provide evidence of the following:
The classification of a medical device determines the conformity assessment procedures a manufacturer can choose to ensure that the device is adequately assessed. Higher classification devices must undergo more stringent conformity assessment procedures.
For some manufacturers, the TGA can only accept TGA Conformity Assessment Certificates.