2. Medical Device Classifications

Medical Devices Class I & II
Australia

This section provides the regulatory classification of the medical devices in scope.

2.1 Preface

Medical devices are classified according to the level of harm they may pose to users or patients in Australia. It is well defined and detailed in Therapeutic Goods (Medical Devices) Regulations 2002 under Part 3 Conformity Assessment Procedures - Division 3.1 Medical device classification. (Reference included under reference [3] below)

As per the Therapeutic Goods (Medical Devices) Regulations 2002, Medical Devices are classified as below:

Figure 1: Medical Devices Classification

*Current Classification - Therapeutic Goods (Medical Devices) Regulations 2002 and new Reclassifications

It is critical to note that, in November 2021, TGA reclassified many types of medical devices. The criteria defined in Therapeutic Goods (Medical Devices) Regulations 2002 under Part 3 Conformity Assessment Procedures Division 3.1 Medical device classification is no longer completely correct and should only serve as a guideline when making decisions on a particular kind of medical device. 

At the date of publication of this document, the most up-to-date classification details must be sought via the TGA website.

The re-classification of certain medical devices came into effect on 25 November 2021. They are outlined in the table below.

Specific Classification Criteria

Medical devices, Class I and Class II (incl Class IIa or IIb or Active I, IIa or IIb ) are defined by the relative risk identified and reasonably expected to present to a patient and/or another end user in the defined course of supply, control, and administering/use of the medical device.

The following criteria will assist in determining the classification of a medical device that is not an In Vitro Diagnostic Device. There are separate classification rules for IVD devices which are not discussed in this document (out of scope).

The TGA processes for evaluating a new medical device proposed by the applicant for inclusion into the Australian Register of Therapeutic Goods (ARTG) consider classification criteria including:

• What does the manufacturer intend the medical device to be used for?
• How invasive will it be in the body (e.g., is it a bandage to be placed on the skin, or a catheter to be inserted into the body)?
• Where on (or in) the body will it be used?
• How long will it be used for?

2.2 Category Name & Definition

Category Name

Applicable to all of Class I, Class IIa, Class IIb, and Active Medical devices if they are other than Class III or IVD.

Definition of the Identification Process

With reference to the Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 2 - Classification rules for medical devices other than IVD medical devices, Parts 1 to 5, and the re-classification criteria of November 2021, the manufacturer must apply those rules and will commence with an assessment against the specific criteria for a defined term of use (time in contact with the patient) of the medical device. To commence identification of which classification might apply to a device - Class I or Class IIa or IIb or Active, risk criteria sets must be applied.

1. The first risk criterion to be applied is the expected time that the medical device will be in contact with a patient or administrator of the device. These criteria are defined as any of:
   1. Transient: the device is to be used continuously for less than 60 minutes.
   2. Short-term: to be used continuously for at least 60 minutes but not more than 30 days.
   3. Long-term use: the device is to be used continuously for more than 30 days.

Once the type of medical device is assessed against the expected time that the medical device will be in contact with a patient, the second risk criteria must then be applied.

2. The second risk criterion to be applied consists of the risk of the device needing to be non-invasive or invasive to the patient to perform its intended functionality. This is separated into two clearly defined parts:
   1. Non-Invasive (specified in Part 2- Rules for non-invasive medical devices, Cls 2.1 to 2.4). There are currently 4 sub-criteria for non-invasive medical devices which, when applied to the type of device, result in classification into either Class I, IIa or Class IIb:
      1. Non-invasive medical devices—general
      2. Non-invasive medical devices intended to channel or store blood, etc.
      3. Non-invasive medical devices intended to modify the biological or chemical composition of blood, etc.
      4. Non-invasive medical devices intended to have contact with injured skin or mucous membrane. (Each of these 4 sub-criteria has further very specific sub-conditions which are defined in Therapeutic Goods (Medical Devices) Regulations 2002; Schedule 2- Classification rules for medical devices other than IVD medical devices, Part 2- Rules for non-invasive medical devices, Clauses 2.1 to 2.4.)
   2. Invasive (specified in Part 3 Rules for invasive medical devices and implantable medical devices; Cls 3.1 to 3.4). There are currently 4 sub-criteria for invasive medical devices which, when applied to the type of device, result in classification into either Class I, Class IIa, Class IIb or Class III.
      • 3.1 invasive medical devices intended to be used by penetration of body orifices
      • 3.2 Surgically invasive medical devices intended for transient use
      • 3.3 Surgically invasive medical devices intended for short-term use
      • 3.4 Surgically invasive medical devices intended for long-term use and implantable medical devices. (Each of these 4 sub-criteria has further very specific sub-conditions which are defined in Therapeutic Goods (Medical Devices) Regulations 2002; Schedule 2 Classification rules for medical devices other than IVD medical devices;  Part 3 Rules for invasive medical devices and implantable medical devices; Cls 3.1 to 3.4 and from Nov 2021, in the Reclassification reforms. The medical device shall meet all the conditions and sub-conditions specified for Class I, II, IIa, and IIb.) 
3. The fourth risk criterion to be applied to assess the classification is Part 4 - Special Rules for Active Medical Devices where intended functionality is achieved by the use of energy in some delivery processes such as:
   1. direct therapy, e.g., ECG
   2. associated therapy, e.g., a dialysis machine
   3. to monitor vital physiological parameters of a patient, e.g., blood pressure monitor

There are currently 4 sub-criteria for Invasive medical devices which, when applied to the type of device, result in classification into either Class I, Class IIa, Class IIb, or Class III.

Part 4 - Special Rules for Active Medical Devices

1. Active medical devices—general
2. Active medical devices for therapy
3. Active medical devices for diagnosis
4. Active medical devices intended to administer or remove medicines, etc., from a patient’s body

Each of these 4 sub-criteria has further very specific sub-conditions which are defined in Therapeutic Goods (Medical Devices) Regulations 2002; Schedule 2 Classification rules for medical devices other than IVD medical devices Part 4—Special rules for active medical devices: Cls 4.1 to 4.4.

*Additionally, the Part 4 section was heavily affected by the Reclassification reforms introduced in November 2021 and the new criteria must be consulted.

The medical device shall meet all the conditions and sub-conditions specified for Class I, II, IIa, and IIb.

4. The fifth risk criterion to be applied to assess the classification is Part 5 - Special rules for particular kinds of medical devices, Cls 5.1 to 5.9. (*Cls 5.1 Does not apply as it is for a Class III)

• 5.2  Medical devices intended for contraception or prevention of sexually transmitted diseases
  • a medical device that is intended by the manufacturer to be used for contraception, or the prevention of sexually transmitted diseases, is classified as Class IIb.
  • If the device is an implantable medical device or an invasive medical device that is intended for long-term use, the device is classified as Class III.
• 5.3 Medical devices intended for disinfecting, cleaning, etc.,
  • A medical device that is intended by the manufacturer specifically to be used for disinfecting, cleaning, rinsing, or hydrating contact lenses is classified as Class IIb.
  • A medical device that is intended by the manufacturer specifically to be used for disinfecting another medical device is classified as Class IIb.
  • This clause does not apply to a medical device that is intended by the manufacturer to be used only to clean another medical device (other than contact lenses) by means of physical action. (Note: A medical device of the kind described in subclause (3) is classified as Class I — see clause 2.1 of this Schedule.)
• 5.4 Non-active medical devices intended to record X-ray diagnostic images: A non-active medical device that is intended by the manufacturer to be used to record X-ray diagnostic images is classified as Class IIa.
• 5.5 Medical devices containing non-viable animal tissues, cells, or other substances, or microbial or recombinant tissues, cells, or other substances.
  • This clause applies to a medical device if the device contains:
    • tissues, cells, or substances of animal origin that have been rendered non-viable, or tissues, cells, or substances of microbial or recombinant origin; or
    • a combination of tissues, cells, or substances of the kind described in paragraph (a).
  • The device is classified as Class III, unless:
    • the device contains only tissues, cells, or substances of animal origin that have been rendered non-viable; and
    • the device is intended by the manufacturer to come into contact with intact skin only. Note: A medical device that conforms with the description in paragraphs (2)(a) and (b) is classified as Class I under clause 2.1 of this Schedule.
• 5.6 Medical devices that are blood bags: A medical device that is a blood bag is classified as Class IIb.
• 5.7 Active implantable medical devices
  • An active implantable medical device is classified as Class AIMD.
  • An implantable accessory to an active implantable medical device is classified as Class III.
  • An active medical device that is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of an active implantable medical device is classified as Class III.
• 5.8 Medical devices intended for export only: Despite any other classification in this Schedule, a medical device that is intended by the manufacturer to be for export only is classified as Class I.
• 5.9 Medical devices that are mammary implants: A medical device that is a mammary implant is classified as Class III.
• 5.10 Medical devices that administer medicines or biologicals by inhalation: If a medical device is intended to be used to administer medicines or biologicals by inhalation:
  • if the mode of action of the device has an essential impact on the efficacy and safety of the medicines or biologicals—the device is classified as Class IIb; or
  • if the device is intended to treat a life-threatening condition—the device is classified as Class IIb; or
  • if paragraphs (a) and (b) do not apply—the device is classified as Class IIa.
• 5.11 Medical devices that are substances to be introduced into the body or applied to and absorbed by the skin: If a medical device is composed of substances, or combinations of substances, that are intended to be (a) introduced into the human body through a body orifice; or (b) applied to and absorbed by the skin; the device is classified as follows:
  • if the device is introduced into the nasal or oral cavity as far as the pharynx, or is applied to and absorbed by the skin, and achieves its intended purpose in that cavity or on the skin—Class IIa;
  • in any other case—Class IIb.

Additionally, the Part 5 section was heavily affected by the re-classification reforms introduced in November 2021 and the new criteria must be consulted.

The medical device shall meet all the conditions and sub-conditions specified for Class I, II, IIa, and IIb. 

2.3 References

1. Therapeutic Goods (Medical Devices) Regulations 2002 - Schedule 2—Classification rules for medical devices other than IVD medical devices, Parts 1, 2, 3, 4, 5

Therapeutic Goods (Medical Devices) Regulations 2002 (legislation.gov.au)