Information & Training. | Medical Devices.
TGA Classification of Medical Devices AustraliaThe medical devices regulatory framework has a classification system for medical devices. The detailed legislation is in:
– 41BD of the Therapeutic Goods Act 1989 (the Act)
– Regulation 3.2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)
– Schedule 2 of the Regulations.
Class 1 are “low” risk
Class 1 devices supplied in a sterile state, Class 1 devices with a measuring function and Class IIa are considered “low-medium” risk
Class IIb are “medium high” risk
Class III are “high” risk.
The manufacturer is responsible for determining the classification of a device using a set of classification rules based on the:
– manufacturer’s intended use of the device
– level of risk to patients, users and other persons (the probability of occurrence of harm and the severity of that harm)
– degree of invasiveness in the human body
– duration of use (classification rule 1)
Identical devices may be classified differently if they are to be used in different parts of the body. This is why the manufacturer’s intended use of the device is so critical to determining the appropriate classification. The intended use can be obtained from the instructions for use, the label, the manufacturer’s advertising materials and technical documentation.
TGA Principles for applying the Classification Rules
The classification rules are based on the manufacturer’s intended purpose, taking into account how the device works. In some cases, more than one rule can apply. If this happens the higher classification applies, with the exception of medical devices for export only (Rule 5.8), which are classified as Class I.
Medical devices incorporating tissues, cells or substances of human origin are regulated as ‘other therapeutic goods’ in accordance with Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004 and will need to comply with the requirements outlined in DR4—Australian medical device requirements under the Therapeutic Goods Act 1989.
All the classification rules must be considered to determine the classification of the medical device. Accessories are classified separate to the medical device they are used with.
If the device is to be used in combination with another medical device, the classification rules must be applied separately to each device. For systems and procedure packs, the classification for the entire system or pack is the highest classification of any individual device in the system or pack. The presence of a medicine in a procedure pack does not effect the classification. For example, if there is a device in the pack that is classified as Class III, then the entire pack is classified as Class III.
Classification of Medical Devices Australia – Software:– that fits the definition of a medical device is also an active medical device since it relies on an energy source for its operation
– that is intended to make a device operate, control a device, or influence the functions of a device generally falls in the same classification as the device
– intended as an accessory to a medical device should be classified separately from the device with which it is used
– is considered an accessory when it is not essential to the operation of the device.
If a medical device is intended to be used in more than one part of a patient’s body, the medical device is classified on the assumption that it will be used in the part of the body that poses the highest risk. For invasive devices, this may be the central circulatory or central nervous systems.
What Classification Rules apply?Is the product a medical device? No. No need to proceed further
Do the special rules under Part 5, Schedule 2 apply? Yes. Apply Classification. Rule 5.
Is the device a non invasive device? Yes. Apply Classification. Rule 2.
Is the device an invasive device? Yes. Apply Classification. Rule 3.
Is the device an active device not covered by Rule 2, 3 or 5? Yes. Apply Classification. Rule 4.
Manufacturers should consider all the Classification Rules when determining the appropriate classification for a device as more than one rule may apply and the higher classification applies, except for devices for export only, which are Class I.
Classification of Medical Devices Australia. Devices with a Measuring Function.
A medical device is considered to have a measuring function if:
– the device is intended by the manufacturer to measure:
– quantitatively a physiological or anatomical parameter
– a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body.
The measurements given by a Medical Device must:
– display in Australian legal units of measurement or other units of measurement acceptable to the TGA, or
– be compared to at least one point of reference indicated in Australian legal units of measurement or other units of measurement acceptable to the TGA, and
– be accurate to enable the device to achieve its intended purpose.
The device must meet each of the above requirements to fit the definition of measuring function.
Manufacturers of medical devices that have a measuring function must prepare evidence that the device complies with the relevant Essential Principles, particularly Essential Principle 10.
For manufacturers of Class I devices that have a measuring function, in addition to preparing an Australian Declaration of Conformity, they must supply the TGA with conformity assessment evidence to demonstrate that the relevant Essential Principles have been met.
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. …
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