Changes have been made to Part 2 of Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) to introduce a new classification rule for non-invasive medical devices that are used to maintain the patency or flush the lumen of another medical device.
Under the new Clause 2.2 of the Regulations, products will be classified as Class IIa medical devices when they are non-invasive, contain only saline and are intended to maintain the patency of, or flush the lumen of, another medical device. Examples include:
- Pre-filled saline flush syringes
- Vascular access device locking solutions
The new classification rules will apply to applications for inclusion in the ARTG from 07 September 2026. Existing ARTG entries and applications lodged prior to 07 September 2026 will have a five-year transition period from this date to meet the new requirements.
The change provides greater clarity about how these products are regulated. It also clarifies that Clause 5.1 applies to medical devices that contain a medicine, while saline only products covered by the new rule will be classified as Class IIa under Clause 2.2.
