Australia Classifies Saline-Only Flush Devices as Class IIa and Rewrites the CDSS Exemption

Australia’s Governor-General made the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 (F2026L01167) on 3 September 2026. The Federal Register recorded the instrument as registered on 7 September 2026. It is a final amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) and the Therapeutic Goods Regulations 1990, made under the Therapeutic Goods Act 1989.

Two device measures in that instrument are the subject of this article. They commence on different dates:

Section 2(1) gives effect to column 2 of the commencement table. Column 3 supplies the corresponding calendar dates for information; section 2(2) says that column 3 is not part of the instrument.

The Therapeutic Goods Administration (TGA) news page on classification and the TGA news page on the CDSS exemption are useful signposts. They are not a substitute for the instrument. The classification news page refers to “Clause 2.2” and to applications for inclusion in the Australian Register of Therapeutic Goods (ARTG) “from 07 September 2026”. The instrument inserts clause 2.2A after clause 2.2, and Part 1 commences on 8 September 2026.

Clause 2.2A: saline-only devices that flush or keep another device patent

Schedule 1, item 1 inserts clause 2.2A into Schedule 2 of the MD Regulations (classification rules for medical devices other than in vitro diagnostic (IVD) devices). A medical device is classified as Class IIa if all of the following are met:

• it is a non-invasive medical device;
• the manufacturer intends it to be used to maintain the patency of another medical device, or to flush the lumen of another medical device; and
• it only contains saline for that purpose.

The clause’s examples are pre-filled saline flush syringes and vascular access device locking solutions.

Pure Global’s reading of these express limits is that clause 2.2A does not cover:

• devices that contain a substance other than saline (for example a heparin or antimicrobial lock);
• devices whose intended purpose is not maintaining patency of, or flushing the lumen of, another medical device;
• invasive devices; or
• irrigation of tissue, even with saline, unless that use also meets the clause 2.2A purpose test. The explanatory statement’s consultation narrative uses the word “irrigate”; clause 2.2A does not.

Schedule 1, item 2 adds a note at the end of Schedule 2 subclause 5.1(1). Clause 5.1 classifies as Class III a device of any kind that incorporates, or is intended to incorporate, as an integral part, a substance that would be a medicine if used separately and that is liable to act on a patient’s body with action ancillary to that of the device. The new note states that clause 5.1 does not apply to medical devices that do not incorporate medicines, such as a device containing only saline, and points to clause 2.2A for the saline-only flush / patency example.

The explanatory statement records TGA’s policy that, where the primary intended purpose of the saline is to flush, irrigate, or maintain the patency of a medical device, the saline is not considered a medicine in that context, and that such products are regulated as Class IIa unless they contain ancillary medicinal substances, in which case they are Class III. That is the statement’s characterisation of the classification approach. The operative tests remain clause 2.2A (saline-only, specified purpose, Class IIa) and clause 5.1 (integral medicine with ancillary action, Class III).

Clause 2.2A assigns a classification; it does not itself grant ARTG inclusion or an exemption from inclusion. Pure Global’s practical interpretation is that sponsors should use the classification result in their applicable inclusion and conformity assessment process, rather than treat it as a supply authorization.

Who must apply clause 2.2A now, and who has five years

Schedule 1, item 36 inserts Division 11.26 into Part 11 of the MD Regulations.

Regulation 11.87 defines a transitional kind of medical device as a kind included in the ARTG because of an application made before Part 1 commencement (8 September 2026), whether the inclusion day was before, on, or after that commencement.

Regulation 11.88 then splits the application of clause 2.2A:

• New applications. Clause 2.2A applies to an application for inclusion made on or after 8 September 2026, and to a kind included as a result of such an application.
• Transitional kinds. Clause 2.2A applies to a transitional kind on and after the end of the period of 5 years beginning on Part 1 commencement.

The instrument does not print a calendar end-date for that five-year period, and it does not prescribe a particular reclassification form. Pure Global recommends that sponsors of kinds included because of pre-8 September applications calendar the five-year application rule and confirm with TGA how their ARTG entries should be aligned when clause 2.2A applies.

If TGA subsequently includes a kind because of an application lodged before 8 September 2026, that included kind is transitional even though the inclusion occurs later. A pending application is not itself an included kind, and this provision does not authorize supply while the application is pending. A kind included because of an application lodged on or after 8 September 2026 does not meet that transitional definition.

CDSS exemption: the legal test from 1 November 2026 is five limbs

Schedule 4 Part 2 of the MD Regulations exempts specified kinds of medical devices from ARTG inclusion if the conditions in the third column of the table are met. Item 2.15 is the exemption for clinical decision support system (CDSS) software.

Schedule 1, item 48, commencing 1 November 2026, repeals only the “Kinds of medical devices” cell of item 2.15 and substitutes a new cell. The conditions cell is not amended.

The following Pure Global comparison reproduces the material statutory wording of the substituted cell and compilation F2026C00610 of the MD Regulations, which was in force immediately before Part 1 commenced:

All five limbs of the new cell are cumulative, and the conditions in column 3 must also be met. A regulated medical device that fails a limb cannot rely on item 2.15. Pure Global recommends confirming the applicable ARTG inclusion requirement or another lawful supply route before continuing supply; failure of this particular exemption does not determine every other pathway.

The explanatory statement says the substitution “seeks to clarify that some products will not meet CDSS exemption criteria, and remove perceived ambiguity.” It expressly identifies the changes to paragraph (b) (dropping “directly”; adding “compress” and “decompress”), new paragraph (d), and new paragraph (e). It does not separately explain the rewritten paragraph (a). TGA’s CDSS news page states that the amendments “do not change the scope of the CDSS exemption or introduce new regulatory requirements.” TGA therefore characterizes the amendment as a clarification. The comparison above identifies changes to the statutory wording, not a finding that TGA has newly brought a particular product into regulation. Manufacturers should document how their products meet the substituted five-limb cell when it applies from 1 November 2026.

TGA’s CDSS guidance, as reviewed on 9 September 2026, sets out the three-criterion exemption that precedes the November amendment, including “directly” in criterion (b). The presence of the earlier test before commencement does not establish a conflict with current law. For the November assessment, use the substituted wording above.

The exemption conditions did not change

Item 48 does not amend column 3 of item 2.15. Its existing conditions include compliance with the essential principles, the manufacturer’s application of appropriate conformity assessment procedures at all times, evidence and information duties, and access for authorized inspections. Condition (g) also requires that the Secretary has not directed supply to stop or cease because it compromises public health and safety.

The following existing notification and reporting conditions remain relevant:

• Condition (h): the manufacturer or sponsor must provide the information specified in subsections 41MP(2) or 41MPA(2) of the Act within the periods set out in this condition. From awareness, these are 48 hours for a serious public-health threat; 10 days for an event leading to death or serious deterioration; 30 days for an event whose recurrence might have those consequences; and 60 days in other cases. These periods are stated in the regulations, rather than in the cited Act subsections.
• Condition (i)(ii): the sponsor must notify the Secretary of importation or supply by or on its behalf on or after 25 February 2021, using the form approved in writing by the Secretary, within 20 working days of that importation or supply, or a longer period agreed by the Secretary. This is not a new November notification duty.

There is a separate source discrepancy: the TGA CDSS guidance reviewed on 9 September 2026 says 30 working days for supply notification, while condition (i)(ii) says 20 working days unless the Secretary agrees to a longer period. Pure Global recommends planning against the statutory 20-working-day period and obtaining confirmation of any longer period applicable to the sponsor, rather than assuming the web guidance grants an extension.

Exemption from ARTG inclusion is not exclusion from TGA regulation.

Which CDSS products the new cell applies to

Schedule 1, item 49 inserts regulation 11.90. The amended item 2.15 applies to:

• a medical device manufactured on or after 1 November 2026; and
• a medical device manufactured before that date that the manufacturer intends to be used on or after that date.

There is no five-year transition equivalent to regulation 11.88. Software already manufactured, if it is still intended for use on or after 1 November 2026, is assessed against the substituted cell.

What manufacturers and sponsors should do

The following are Pure Global’s operational recommendations based on the provisions above, not additional requirements announced by TGA.

Saline flush syringes and vascular access locking solutions

1. Map the intended purpose and composition to clause 2.2A. Check that the device is non-invasive, is intended to maintain patency of or flush another device’s lumen, and contains only saline for that purpose; clause 2.2A assigns Class IIa to that combination. A lock or flush that contains an ancillary medicine is outside 2.2A; check clause 5.1.
2. Use 8 September 2026 as the application-date split. Applications made on or after that day are classified under 2.2A. Kinds included because of an earlier application have the five-year transitional application rule in regulation 11.88(2).
3. Do not take classification dates or the clause number from the TGA news page. Follow the instrument’s commencement table and clause 2.2A.

CDSS software

4. Re-run the exemption assessment against all five limbs before 1 November 2026, including products already on the market that remain intended for use on or after that date. Pay particular attention to paragraph (a)’s “make a recommendation … assisting … a decision” wording, paragraph (b)’s compress/decompress language, paragraph (d)’s diagnosis/treatment-decision and IVD-software limb, and paragraph (e)’s requirement to display guidelines, calculations or logic so a health professional can interpret and verify recommendations in the intended clinical context.
5. Record both TGA’s clarification policy and your product-specific assessment of the amended text. The old three-criterion assessment should be checked against the wording that applies from 1 November.
6. Keep the item 2.15 conditions in the operating procedures, including the 20-working-day notification period unless a longer period is agreed, and the condition (h) reporting periods. Those conditions were not rewritten.

The official sources are the as-made instrument, the explanatory statement, and compilation F2026C00610 for the pre-amendment item 2.15 cell. For ARTG inclusion and Australian Sponsor requirements more generally, see Pure Global’s Australia market page. Pure Global’s coverage of TGA’s 2026 AI and software guidance is a separate publication about guidance, distinct from this amending instrument.