Essential Principles Medical Devices. TGA Australia Regulation.
Information & Training. | Medical Devices.What are the Essential Principles? From the Therapeutic Goods Act …
The Essential Principles set out the requirements relating to the safety and performance characteristics of medical devices.
For a medical device to be supplied in Australia, it must be demonstrated that the relevant Essential Principles have been met. The regulatory framework provides flexibility for manufacturers and caters for technological advances and changes in the development of new medical devices by not dictating how a manufacturer must prove that they have met the Essential Principles.
It is the manufacturer’s responsibility to demonstrate compliance for their medical devices.
There are six general principles that apply to all devices. There are a further nine principles about design and construction that apply to devices on a case-by-case basis.
– Use of medical devices must not compromise health and safety
– Design and construction of medical devices need to conform to safety principles
– Medical devices need to be suitable for the intended purpose
– Long-term safety must be considered
– Medical devices are not to be adversely affected by transport or storage
– The benefits of a medical device must outweigh any side effects
– Chemical, physical and biological properties need to be considered
– Infection and microbial contamination need to be assessed
– Construction and environmental properties must be considered
– Medical devices with a measuring function have specific requirements
– Protection against radiation needs to be included within the device design
– Medical devices connected to or equipped with an energy source have a higher classification
– Information to be provided with medical devices must be readable and understandable
– Clinical evidence is required prior to placing the device onto the market
Principles covering design and construction.
Demonstrating compliance with the Essential Principles.A checklist that manufacturers may complete to demonstrate how they have complied with the Essential Principles for a particular medical device is available on the TGA website.
Once a design specification that minimizes the identified risks has been defined, the manufacturer will need to decide how to demonstrate that it meets the relevant Essential Principles. In many instances this will be achieved through implementation, maintenance and regular inspection of a quality management system by the device manufacturer.
Manufacturers can demonstrate that the Essential Principles have been met for a device in many ways. Some examples include:
- A documented and detailed risk analysis
- The results of testing of the medical device
- Literature search
- Copies of the label, packaging and user instructions.
Information & Training.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>
Therapeutic Goods Administration