Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 1/11)
Character Range: 312597–315341

Schedule 2—Classification rules for medical devices other than IVD medical devices
Note: Regulation 3.2 provides for the making of classification rules. Regulation 3.3 sets out the principles for applying those rules.

Part 1—Interpretation

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.

2.3  Non‑invasive medical devices intended to modify the biological or chemical composition of blood, etc
 (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