On 8 September 2026, the Australian Therapeutic Goods Administration (TGA) published updates to the classification rules for certain combination products. The update expressly classifies non-invasive medical devices that contain only saline and are intended to maintain the patency of, or flush the lumen of, another medical device as Class IIa.
Source: TGA — Updated classification rules for certain combination products
https://www.tga.gov.au/news/news-articles/updated-classification-rules-certain-combination-products
1. New Class IIa Classification Rule
Under the newly introduced Clause 2.2A, products that satisfy all of the following conditions shall be classified as Class IIa medical devices:
| Criterion | Specific Requirement |
| Device attribute | The device is a non-invasive medical device. |
| Intended use | It is intended to maintain the patency of another medical device, or to flush the lumen of another medical device. |
| Composition | It contains only saline, used solely for the purpose described above. |
Examples: pre-filled saline flush syringes; vascular access device locking solutions.
2. Saline-Only Products Are Not Assessed Under the Drug/Device Combination Rules
The amendment also adds an explanatory note to Clause 5.1 of Schedule 2. Clause 5.1 applies to medical devices that contain a medicine; however, products containing only saline do not fall within the meaning of “medical device containing a medicine” as referred to in that clause.
Consequently, non-invasive products that contain only saline and are intended to maintain the patency of, or flush the lumen of, another medical device are to be classified as Class IIa under the newly introduced Clause 2.2A, rather than assessed under the classification rules for medical devices containing a medicine.
3. Commencement and Transition
According to the information published by TGA, the relevant amendment legislation was registered on 7 September 2026, and the provisions containing the new classification rule took effect on 8 September 2026.
The new classification rules apply to applications for inclusion in the ARTG from 7 September 2026. Existing ARTG entries and applications lodged before 7 September 2026 have a five-year transition period from that date to meet the new requirements.
4. Implications for Regulated Companies
This amendment clarifies the basis on which products such as pre-filled saline flush syringes and vascular access device locking solutions are classified in Australia, and is expected to reduce the uncertainty previously associated with the classification of saline-only products.
Companies concerned should pay particular attention to the following:
- Verify whether the product simultaneously satisfies the device is non-invasive, is intended to maintain patency or flush a lumen, and contains only saline, confirm that all three conditions are met;
- Classification — new applications should be prepared in accordance with Class IIa requirements, including conformity assessment evidence and registration documentation;
- Transition period — existing ARTG entries and applications lodged during the transition period should confirm the applicable deadline and arrange compliance adjustments in advance;
- Products containing other substances — if the product contains any component other than saline, its classification cannot be determined solely under the new Clause 2.2A; further assessment is required based on the product composition, mode of action and intended use.