THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - SCHEDULE 2 Classification rules for medical devices other than IVD medical devices
THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - SCHEDULE 2
Classification rules for medical devices other than IVD medical devicesNote: Regulation 3.2 provides for the making of classification rules. Regulation 3.3 sets out the principles for applying those rules.
1.1 Transient, short - term and long - term use
(1) For the purposes of this Schedule:
(a) a medical device is intended for transient use if the manufacturer intends the device to be used continuously for less than 60 minutes; and
(b) a medical device is intended for short - term use if the manufacturer intends the device to be used continuously for at least 60 minutes but not more than 30 days; and
(c) a medical device is intended for long - term use if the manufacturer intends the device to be used continuously for more than 30 days.
(2) For the purposes of determining whether a medical device is intended to be used continuously, disregard any temporary interruption or removal.
Example: A temporary interruption or removal in order to clean or disinfect the medical device.
Part 2 -- Rules for non - invasive medical devices
2.1 Non - invasive medical devices--general
A non - invasive medical device is classified as Class I, unless the device is classified at a higher level under another clause in this Part or in Part 4 or 5 of this Schedule.
2.2 Non - invasive medical devices intended to channel or store blood, etc
(1) This clause applies to:
(a) a non - invasive medical device that is intended by the manufacturer to be used to channel or store blood or body liquids that are to be infused, administered or introduced into a patient; and
(b) a non - invasive medical device that is intended by the manufacturer to be used to store an organ, part of an organ or body tissue that is to be later introduced into a patient; and
(c) a non - invasive medical device that:
(i) is intended by the manufacturer to be used to channel or store a liquid or gas that is to be infused, administered or introduced into a patient; and
(ii) may be connected to an active medical device classified as Class IIa or higher.
(2) The device is classified as Class IIa.
(1) Subject to subclause (2), a non - invasive medical device that is intended by the manufacturer to be used to modify the biological or chemical composition of blood, other body liquids, or other liquids intended to be infused into a patient, is classified as Class IIb.
(2) If the treatment for which the device is designed consists of filtration, centrifugation or exchanges of gas or heat, the device is classified as Class IIa.
2.4 Non - invasive medical devices intended to have contact with injured skin or mucous membrane
(1) This clause applies to a non - invasive medical device that is intended by the manufacturer to be used in contact with injured skin or a mucous membrane (including a device the principal intention of which is to manage the micro - environment of a wound).
(2) Subject to subclauses (3) and (4), the device is classified as Class IIa.
(3) If the device is intended to be used:
(a) as a mechanical barrier; or
(b) for compression; or
(c) for the absorption of exudates;
the device is classified as Class I.
(4) If the device is intended to be used principally for wounds that have breached the dermis and the wounds can only heal by secondary intent, the device is classified as Class IIb.
Part 3 -- Rules for invasive medical devices and implantable medical devices
3.1 Invasive medical devices intended to be used by penetration of body orifices
(1) This clause applies to an invasive medical device (other than a surgically invasive medical device or a medical device covered by clause 5.10 or 5.11) that is intended by the manufacturer to be used to penetrate a body orifice of a patient.
(2) If the device is not intended to be connected to an active medical device, the following rules apply:
(a) if the device is intended for transient use, the device is classified as Class I;
(b) if the device is intended for short - term use:
(i) the device is classified as Class IIa; or
(ii) if the device is intended to be used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum, or in a nasal cavity--the device is classified as Class I;
(c) if the device is intended for long - term use:
(i) the device is classified as Class IIb; or
(ii) if the device is intended to be used in the oral cavity as far as the pharynx or in an ear canal up to the ear drum, or the device is intended to be used in a nasal cavity and the device is not liable to be absorbed by the skin or mucous membrane--the device is classified as Class IIa.
(3) If the device is intended to be connected to an active medical device that is classified as Class IIa or higher, the device is classified as Class IIa.
3.2 Surgically invasive medical devices intended for transient use
(1) This clause applies to a surgically invasive medical device that is intended for transient use.
(2) Subject to subclauses (3) to (5), the device is classified as Class IIa.
(3) If the device is intended by the manufacturer specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body, the device is classified as Class III.
(3A) If the device is not a reusable surgical instrument and the device is intended by the manufacturer specifically to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient, the device is classified as Class III.
(4) If the device is a reusable surgical instrument, the device is classified as Class I.
(5) If:
(a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or
(b) the device is intended by the manufacturer to have a biological effect; or
(c) the device is intended by the manufacturer to be wholly, or mostly, absorbed by the patient's body; or
(d) the device is intended by the manufacturer to be used to administer medicine to a patient by means of a delivery system, and the administration is potentially hazardous to the patient having regard to the characteristics of the device;
the device is classified as Class IIb.
3.3 Surgically invasive medical devices intended for short - term use
(1) This clause applies to a surgically invasive medical device that is intended for short - term use.
(2) Subject to subclauses (3) and (4), the device is classified as Class IIa.
(3) If:
(a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or
(b) the device is intended by the manufacturer to undergo a chemical change in a patient's body (other than a device that is intended by the manufacturer to be placed in the teeth); or
(c) the device is intended by the manufacturer to administer medicine;
the device is classified as Class IIb.
Note for paragraph (b): A device that is intended by the manufacturer to be placed in the teeth, and to undergo a chemical change in the body, is classified as Class IIa--see subclause (2).
(4) If the device is intended by the manufacturer:
(a) specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body; or
(b) specifically to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient; or
(c) to have a biological effect; or
(d) to be wholly, or mostly, absorbed by a patient's body;
the device is classified as Class III.
(5) For this clause, a medical device that is intended by the manufacturer to be placed in the teeth includes a medical device that is intended by the manufacturer to penetrate a tooth, but does not include a medical device that is intended by the manufacturer to penetrate a tooth and enter the gum or bone beyond the tooth.
3.4 Surgically invasive medical devices intended for long - term use and implantable medical devices
(1) This clause applies to:
(a) a surgically invasive medical device that is intended for long - term use; and
(b) an implantable medical device.
(2) Subject to subclauses (3), (4), (4A) and (4B), the device is classified as Class IIb.
(3) If the device is intended by the manufacturer to be placed in the teeth of a patient, the device is classified as Class IIa.
(4) If the device is intended by the manufacturer:
(a) to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient; or
(b) to have a biological effect; or
(c) to be wholly, or mostly, absorbed by a patient's body; or
(d) to undergo a chemical change in a patient's body (other than a device that is intended by the manufacturer to be placed in the teeth); or
(e) to be used to administer medicine;
the device is classified as Class III.
Note for paragraph (d): A device that is intended by the manufacturer to be placed in the teeth, and to undergo a chemical change in the body, is classified as Class IIa--see subclause (3).
(4A) The device is classified as Class III if it is:
(a) a joint replacement medical device; or
(b) surgical mesh.
(4B) If the device is intended by the manufacturer to be a motion - preserving device for the spine (such as a spinal disc replacement), the device is classified as Class III.
(5) For this clause, a medical device that is intended by the manufacturer to be placed in the teeth includes a medical device that is intended by the manufacturer to penetrate a tooth, but does not include a medical device that is intended by the manufacturer to penetrate a tooth and enter the gum or bone beyond the tooth.
Part 4 -- Special rules for active medical devices
4.1 Active medical devices--general
An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this Part or in Part 2, 3 or 5.
4.2 Active medical devices for therapy
(1) Subject to subclause (2), an active medical device for therapy that is intended by the manufacturer to be used to administer energy to a patient, or exchange energy to or from a patient, is classified as Class IIa.
(2) If the device is of a kind such that the administration or exchange of energy occurs in a potentially hazardous way, having regard to the nature, density and site of application of the energy, the device is classified as Class IIb.
(3) 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 medical device for therapy of the kind mentioned in subclause (2) is classified as Class IIb.
(4) An active medical device for therapy that includes a diagnostic function the purpose of which is to significantly determine patient management by the device is classified as Class III.
Example: An automated external defibrillator.
4.3 Active medical devices for diagnosis
(1) This clause applies to an active medical device for diagnosis.
(2) If:
(a) the device is intended by the manufacturer to be used to supply energy that will be absorbed by a patient's body (other than a device that is intended only to illuminate the patient's body in the visible spectrum); or
(b) the device is intended by the manufacturer to be used to image in vivo distribution of radiopharmaceuticals in a patient; or
(c) the device is intended by the manufacturer to be used to allow direct diagnosis or monitoring of vital physiological processes of a patient (other than a device of a kind mentioned in paragraph (3)(a));
the device is classified as Class IIa.
Note for paragraph (a): A device that is intended only to illuminate the patient's body in the visible spectrum is classified as Class I--see clause 4.1 of this Schedule.
(3) If:
(a) the device is intended by the manufacturer specifically to be used to monitor vital physiological parameters of a patient, and the nature of the variations monitored is of a kind that could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system); or
(b) the device is intended by the manufacturer to emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology; or
(c) the device is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of a device of the kind mentioned in paragraph (b);
the device is classified as Class IIb.
4.4 Active medical devices intended to administer or remove medicines, etc from a patient's body
(1) Subject to subclause (2), an active medical device that is intended by the manufacturer to be used to administer medicine, body liquids or other substances to a patient, or to remove medicine, body liquids or other substances from a patient, is classified as Class IIa.
(2) If the device is of a kind such that the administration or removal of the medicine, body liquids or other substances is potentially hazardous to the patient, having regard to the nature of the substances involved, the part of the patient's body concerned, and the characteristics of the device, the device is classified as Class IIb.
(1) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to:
(a) provide a diagnosis of a disease or condition; or
(b) screen for a disease or condition;
is classified as:
(c) in the case of a disease or condition that:
(i) may lead to the death of a person, or a severe deterioration in the state of a person's health, without urgent treatment; or
(ii) may pose a high risk to public health;
Class III; or
(d) in the case of a serious disease or serious condition or a disease or condition that may pose a moderate risk to public health, and where paragraph (c) does not apply--Class IIb; or
(e) in any other case--Class IIa.
(2) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to provide information to a relevant health professional for the purposes of the health professional making a diagnosis of a disease or condition:
(a) in the case of a disease or condition that:
(i) may lead to the death of a person, or a severe deterioration in the state of a person's health, without urgent treatment; or
(ii) may pose a high risk to public health;
is classified as Class IIb; or
(b) in the case of a serious disease or serious condition or a disease or condition that may pose a moderate risk to public health, and where paragraph (a) does not apply--is classified as Class IIa; or
(c) in any other case--is classified as Class I.
A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to provide information that is to be used for monitoring the state or progression of a disease or condition of a person or the parameters in relation to a person:
(a) in the case where the information to be provided could indicate that the person or another person may be in immediate danger or that there may be a high risk to public health--is classified as Class IIb; or
(b) in the case where the information to be provided could indicate that the person or another person may be in other danger or that there may be a moderate risk to public health--is classified as Class IIa; or
(c) in any other case--is classified as Class I.
(1) Subject to subclause (2), a programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to specify or recommend a treatment or intervention:
(a) in the case where the absence of the treatment or intervention or where the treatment or intervention itself:
(i) may lead to the death of a person or a severe deterioration in the state of a person's health; or
(ii) may pose a high risk to public health;
is classified as Class III; or
(b) in the case where the absence of the treatment or intervention or where the treatment or intervention itself:
(i) may otherwise be harmful to a person; or
(ii) may pose a moderate risk to public health;
is classified as Class IIb; or
(c) in any other case--is classified as Class IIa.
(2) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to recommend a treatment or intervention (the recommended treatment or intervention ) to a relevant health professional for the purposes of the health professional making a decision about the treatment or intervention:
(a) in the case where the absence of the recommended treatment or intervention or where the recommended treatment or intervention itself:
(i) may lead to the death of a person or a severe deterioration in the state of a person's health; or
(ii) may pose a high risk to public health;
is classified as Class IIb; or
(b) in the case where the absence of the recommended treatment or intervention or where the recommended treatment or intervention itself:
(i) may otherwise be harmful to a person; or
(ii) may pose a moderate risk to public health;
is classified as Class IIa; or
(c) in any other case--is classified as Class I.
A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to provide therapy to a person through the provision of information to the person:
(a) in the case of therapy that may result in the death of the person or a severe deterioration in the state of the person's health--is classified as Class III; or
(b) in the case of therapy that may cause serious harm to the person and where paragraph (a) does not apply--is classified as Class IIb; or
(c) in the case of therapy that may cause harm to the person and where neither paragraph (a) nor (b) applies--is classified as Class IIa; or
(d) in any other case--is classified as Class I.
Part 5 -- Special rules for particular kinds of medical devices
5.1 Medical devices incorporating a medicine
(1) This clause applies to a medical device of any kind that incorporates, or is intended to incorporate, as an integral part, a substance that:
(a) if used separately, would be a medicine; and
(b) is liable to act on a patient's body with action ancillary to that of the device.
(2) The device is classified as Class III.
(3) For the purposes of this clause, any stable derivative of human blood or human plasma is considered to be a medicine.
5.2 Medical devices intended for contraception or prevention of sexually transmitted diseases
(1) Subject to subclause (2), 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.
(2) 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
(1) 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.
(2) A medical device that is intended by the manufacturer specifically to be used for disinfecting another medical device is classified as Class IIb.
(3) 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 Medical devices that record patient images or that are anatomical models etc.
(1) If:
(a) a medical device is intended by the manufacturer to be used to record patient images that are to be used for either or both of the following:
(i) the diagnosis or monitoring of a disease, injury or disability;
(ii) the investigation of the anatomy or of a physiological process; and
(b) the images are to be acquired through a method that relies on energy outside the visible spectrum;
the device is classified as Class IIa.
(2) A medical device that is an anatomical model (whether physical or virtual) that is intended by the manufacturer to be used for either or both of the following:
(a) the diagnosis or monitoring of a disease, injury or disability;
(b) the investigation of the anatomy or of a physiological process;
is classified as Class IIa.
(3) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to generate a virtual anatomical model that is to be used for either or both of the following:
(a) the diagnosis or monitoring of a disease, injury or disability;
(b) the investigation of the anatomy or of a physiological process;
is classified as Class IIa.
(1) This clause applies to a medical device if the device contains:
(a) tissues, cells or substances of animal origin that have been rendered non - viable, or tissues, cells or substances of microbial or recombinant origin; or
(b) a combination of tissues, cells or substances of the kind described in paragraph (a).
(2) The device is classified as Class III, unless:
(a) the device contains only tissues, cells or substances of animal origin that have been rendered non - viable; and
(b) 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
(1) An active implantable medical device is classified as Class III.
(2) An implantable accessory to an active implantable medical device is classified as Class III.
(3) 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:
(a) 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
(b) if the device is intended to treat a life - threatening condition--the device is classified as Class IIb; or
(c) 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:
(c) 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;
(d) in any other case--Class IIb.