Medical Device Classification TGA Australia
Information & Training Presentation. | Medical Device Validation, Regulation, Classification, …
Classification Rule 2. Non-Invasive Medical Devices.
Rule 2.1 Non-invasive medical devices—generalThis rule applies to all medical devices that are not covered by a specific rule, devices that contact intact skin and devices that do not touch the patient.
|A non-invasive device is Class I, unless the device is classified at a higher level under another rule in Schedule 2 of the Regulations.|
Rule 2.2 Non-invasive devices intended to channel or store blood, etcDevices covered under this rule may include those that channel or store substances that will be eventually delivered into the body.
|2.2(1)(a)A non-invasive device used to channel or store blood or body liquids that are to be infused, administered or introduced into a patient—Class IIa.||Devices intended to be used to channel active drug delivery systems. Examples: intravenous tubing, gastrostomy tubing, anaesthesia breathing circuits and pressure indicator and syringes for infusion pumps.|
|2.2(1)(b)A non-invasive device to store an organ, parts of an organ or body tissue that is to be later introduced into a patient—Class IIa.||Examples: Devices to temporarily store and transport of organs for transplant or for long-term storage of biological substances and tissues such as corneas, sperm and human embryos.|
|2.2(1)(c)A non-invasive device to channel or store a liquid or gas that is to be infused, administered or introduced into a patient and may be connected to an active medical device classified as Class IIa or higher—Class IIa.||Examples: oxygen tubing and masks; anaesthetic tubing and breathing circuits; and syringes and tubing for infusion pumps.|
Rule 2.3 Non-invasive devices intended to modify the biological or chemical composition of blood, etcDevices in this category must be considered separately from those in Rule 2.2, as they treat or modify substances that will be delivered into the body.
|2.3(1)A non-invasive device to modify the biological or chemical composition of blood, other body liquids, or other liquids to be infused in the patient—Class IIb.||Devices intended to remove undesirable substances out of the blood by exchange of solutes such as hemodyalizers. Examples: Auto transfusion systems.Devices used to separate cells such as gradient medium for sperm.|
|2.3(2)A non-invasive device to be used in treatment consisting of filtration, centrifugation or exchanges of gas or heat—Class IIa.||Examples: particulate filtration of blood in an extracorporeal circulation system, centrifugation of blood for transfusion or autotransfusion, removal of carbon dioxide from the blood and/or adding oxygen, and warming or cooling blood in the extracorporeal circulatory system.|
Rule 2.4 Non-invasive devices intended to have contact with injured skinThis rule covers wound dressings without consideration of the wound depth. The technology associated with these devices is well understood and they are not considered potentially hazardous to the patient.
|2.4(1)A non-invasive device to be used in contact with injured skin (including a device the principal intention of which is to manage the microenvironment of a wound)—Class IIa.||Assists healing by controlling the level of moisture and regulating the humidity, temperature, levels of oxygen, other gases and pH values of the wound environment, or by influencing the process by other physical means.Examples: adhesives for topical use, polymer film dressings, hydrogel dressings and non-medicated impregnated gauze dressings.|
|2.4(3)A non-invasive device to be used as a mechanical barrier or for compression or for absorption of exudates—Class I.||Examples: absorbent pads, island dressings, cotton wool, wound strips and gauze dressings to act as a barrier or absorb exudates from the wound.Please note: if the device is sterile conformity evidence is required.|
|2.4(4)A non-invasive device to be used for wounds that have breached the dermis and where the wounds can only heal by secondary intent—Class IIb.||Intended for severe wounds that have extensively breached the dermis, and healing is by secondary intent (by granulation from the base of the wound).Examples: dressings for chronic extensive ulcerated wounds, severe burn, severe decubitus wounds, or dressings providing a temporary skin substitute.|
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).
- NewEuropean 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. …
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