Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 2/11)
Character Range: 315088–317614

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