A distributor, a provincial procurement office, or a programme manager can still have two documents in the same file. One is National Treasury Addendum 3, dated 25 September 2024, which says that from 1 January 2025 dorsal slit will be contra-indicated for young adolescents and only the surgical aid will be permitted. The other is a news report that the High Court set the circumcision-device tender aside.127
Those two readings do not answer the same question. Addendum 3 does not mention the later order. Medical Brief's page is a republication of one GroundUp report, the same chain carried by other news sites. It is a readable account of the hearing. It is not a clause-and-date matrix. That page says the judge barred direction to use CircumQ on boys under 14. The order says males aged 10 to 14. A file that copies "under 14" from the news story is no longer quoting the order.127
The decision for an incoming file, as of 1 October 2026, is narrower. Can the paper still require CircumQ for males aged 10 to 14? Which sentence controls ages 15 and above? Which end date is the buyer looking at? This guide answers those three questions from the order and the Treasury circulars. It is not a method for performing circumcision, and it does not choose a device for a named patient.
Which sentence in the 25 September 2024 addendum still says CircumQ is mandatory?
The circular that still sits in clinic files is Addendum 3 to transversal contract RT35-1-2023. Manthepeng Tshinavha signed it on 25 September 2024 for the Chief Directorate: Transversal Contracting. The heading is Addendum 3. The public file name says Amendment 2. Use the heading when you cite it, and keep the file name so a colleague can find the PDF.2
The contract banner covers voluntary medical male circumcision services to the state for the period 7 December 2023 to 30 August 2026. The operative sentences are these.2
As indicated in the Special Condition of Contract (SCC) paragraph 5.10, The circumcision procedure for males aged 10 -14 years must only be conducted using the surgical aid provided for by the participating provincial departments in the respective districts.— National Treasury Addendum 3, RT35-1-2023, 25 September 2024
All service providers on RT35-1-2023 have until 31 December 2024 to ensure that relevant clinicians undergo training on the use of the surgical aid. Effective 1 January 2025, the dorsal slit method will be contra-indicated for young adolescents and only the use of the surgical aid will be permitted. Non-compliance with this provision on the SCC will be regarded as a bridge of contracts and the State reserves the right to cancel the contract with the relevant service provider.— National Treasury Addendum 3, RT35-1-2023, 25 September 2024
The awarded surgical aid on the contract is the CircumQ and therefore service providers must contact CircumQ (contact details on the contract circular) for training information in this regard.— National Treasury Addendum 3, RT35-1-2023, 25 September 2024
Three limits matter before anyone treats that page as a current mandate.2
- The circular does not describe a period of parallel dorsal-slit and device use. It sets a training deadline of 31 December 2024. From 1 January 2025 it says dorsal slit will be contra-indicated for young adolescents and only the surgical aid will be permitted.
- The words "bridge of contracts" appear in the non-compliance sentence. On the page, non-compliance "will be regarded as a bridge of contracts" and the state reserves a right to cancel. That is the printed wording. It is not a statement that provinces built a bridge between the RT35-2019 and RT35-2023 frameworks. RT35-2019 is not named in this PDF.
- The circular is dated 25 September 2024. It cannot, by itself, account for the order delivered on 7 May 2026.
The age band on this page is males aged 10 to 14. The circular does not print a separate optional rule for males aged 15 and above. That split is in the special conditions as the court describes them, not in a second sentence of Addendum 3.12
What did the 7 May 2026 High Court order actually stop for ages 10 to 14?
On 7 May 2026 Judge E van der Schyff delivered judgment in Unicirc (Pty) Ltd v Minister of Finance and Others (2025/051503) [2026] ZAGPPHC 444. Unicirc asked the court to review the National Treasury decision of 20 April 2023 awarding tender RT35-2023, for a surgical assist device used in voluntary medical male circumcision, to CircumQ IP (RF) (Pty) Ltd. The award was communicated to CircumQ on 20 August 2023. The award date in the order remains 20 April 2023.1
The order does four things that a buyer needs to keep apart. The paragraph numbers below are the court's.1
- Paragraph 9 declares the decision of 20 April 2023, awarding tender RT35-2023 to CircumQ IP (RF) (Pty) Ltd, unlawful and invalid.
- Paragraph 10 suspends that declaration until expiry of the contract term, subject to paragraphs 10.1, 10.2, and 10.3. The reasons describe the suspension as a way to avoid administrative disruption, fiscal uncertainty, and harm to service providers near the end of a 36-month contract. They do not call it a cancellation of the national VMMC programme.
- Paragraph 10.1 interdicts and restrains the respondents, with immediate effect from the date of the order, from giving effect to, implementing, or enforcing section 5.10.1 insofar as it requires the mandatory use of the CircumQ surgical assist device for males aged 10 to 14.
- Paragraph 10.2 directs the respondents, from the date of the order and for any remaining period of the contract term, not to require, direct, or obligate any healthcare provider operating under the VMMC programme to use CircumQ when circumcising males aged 10 to 14. The order does not use the word "advising".
- Paragraph 10.3 directs the relevant provincial departments of health, where VMMC services are required for males aged 10 to 14 during any remaining contract term, to ensure that the treating provider is free to apply whichever clinically appropriate method that provider determines to be in the individual patient's best interests. The methods named are the dorsal slit method, or any other method the relevant department considers appropriate having regard to available clinical evidence.
Where voluntary medical male circumcision services are required for males aged 10 to 14 years during any remaining period of the contract term, the relevant provincial departments of health are directed to ensure that the treating healthcare provider is free to apply whichever clinically appropriate method that provider determines to be in the best interests of the individual patient, including the use of the dorsal slit method or any other method in respect of which the relevant department, having regard to available clinical evidence, considers appropriate.— Unicirc (Pty) Ltd v Minister of Finance and Others [2026] ZAGPPHC 444, order paragraph 10.3
The reasons use "clause 5.10.1". The order uses "section 5.10.1". They are the same special condition. Paragraph 10.3 does not say the provider is entirely free of the department's evidence screen, and it does not name CircumQ as one of the methods the department must allow. It also does not say provinces are barred from every form of penalty. The direction is specific: do not require, direct, or obligate use of CircumQ for this age band, and leave the provider free to use a clinically appropriate method on the terms above.1
| Question | Addendum 3 (25 September 2024) | Order (7 May 2026) |
|---|---|---|
| Who is covered | Males aged 10 to 14 | Males aged 10 to 14, in section 5.10.1 |
| CircumQ | The awarded surgical aid. From 1 January 2025, only that aid is permitted for young adolescents | Respondents interdicted from enforcing the mandatory-use rule, and directed not to require, direct, or obligate its use |
| Dorsal slit | Contra-indicated for young adolescents from 1 January 2025 | Named in paragraph 10.3 as one method the provider may use |
| Other methods | Not left open on the face of the circular | Any other method the relevant department considers appropriate on the available clinical evidence |
| What the paper does not do | It does not mention the 7 May 2026 order | It does not appoint a replacement supplier |
Why is the rule for ages 15 and above a different section?
The immediate interdict is not written for every age. At paragraph 138 the court contrasts the two special conditions. Clause 5.10.1 says circumcision for males aged 10 to 14 must be conducted using the surgical aid supplied by the participating provincial departments, with no exception for clinical judgment. Clause 5.10.2 imposes no equivalent compulsion for males aged 15 and above. For that group, the surgical aid is offered as an option based on patient preference.1
Order paragraph 11 then keeps only that older-age contract in force, and only for a limited time.1
Notwithstanding the declaration of invalidity in paragraph 9 above, the Transversal Term Contract concluded between the National Treasury and the sixteenth respondent pursuant to the award of Tender RT35-2023 shall remain in force insofar as it governs the provision of voluntary medical male circumcision services to males aged 15 years and above in terms of section 5.10.2 of the Special Conditions of Contract, and shall continue in that limited respect until the earlier of: (a) the natural expiry of the 36-month contract term commencing on 20 April 2023; or (b) such earlier date as the contract is lawfully terminated.— Unicirc (Pty) Ltd v Minister of Finance and Others [2026] ZAGPPHC 444, order paragraph 11
Do not turn that paragraph into a clean permission running from 7 May 2026 until 31 August 2026. Paragraph 11 ends the 15-and-above continuation at the earlier of two events. One of them is the natural expiry of a 36-month term that starts on 20 April 2023. At paragraph 130, writing on 7 May 2026, the court says that 36-month term "has run to, or is near, its natural expiry." The August dates printed on the Treasury circulars are a different set of sentences. A buyer cannot treat the weeks after judgment as an undisputed right to keep offering CircumQ to males aged 15 and above.123
| Section | Who | How the court describes the original rule | What the order does | Reading on 1 October 2026 |
|---|---|---|---|---|
| 5.10.1 | Males aged 10 to 14 | Mandatory use of the surgical aid. No clinical exception in the clause the court quotes | Immediate interdict and direction in paragraphs 10.1 to 10.3 | Not a basis for requiring CircumQ. Any remaining-term language in the order sits against end dates that have passed |
| 5.10.2 | Males aged 15 and above | An option based on patient preference, not the same compulsion | Left in force only until the earlier of the 36-month term from 20 April 2023 or lawful termination | The court's own expiry formula, and the later August dates on the circulars, are all in the past |
Which end date applies: the court formula, Addendum 3, or the 31 August papers?
The file does not contain one end date. It contains a formula and three printed dates, on four documents.1234
- Order paragraph 11(a) uses the natural expiry of a 36-month term commencing on 20 April 2023. Thirty-six months from 20 April 2023 falls on 20 April 2026. The judgment was delivered on 7 May 2026. Paragraph 130 does not pick 19 April or 20 April in those words. It says the term has run to, or is near, its natural expiry.
- Addendum 3, on contract RT35-1-2023, prints the period 7 December 2023 to 30 August 2026.
- Addendum 1, also on contract RT35-1-2023, is an updated target schedule signed on 30 August 2024. Its banner says the service period ends on 31 August 2026.
- Addendum 2 is the RT35-2023 updated pricing schedule. Its header prints 1 September 2023 to 31 August 2026. The rows price an MMC procedure by district and provider. They are not a unit price for the CircumQ device, and this guide does not republish them.
On 1 October 2026, 20 April 2026, 30 August 2026, and 31 August 2026 had all passed. Addendum 1 shows that the 31 August date is not only a line on the RT35-2023 pricing header. The same contract number as Addendum 3, RT35-1-2023, also prints 31 August 2026. Match the instrument. Do not pick one date and call the others a misprint.234
RT35-2023 is the tender award the court reviewed. RT35-1-2023 is the service-contract number on Addendum 1 and Addendum 3. They are related papers about the same programme and the same named surgical aid. They are not interchangeable citations.12
| Instrument | Reference | Date the paper prints | Status on 1 October 2026 |
|---|---|---|---|
| Order paragraph 11(a) | Tender RT35-2023 | 36 months from 20 April 2023, which falls on 20 April 2026. Reasons on 7 May 2026: the term has run to, or is near, expiry | That anniversary had passed |
| Addendum 3 | RT35-1-2023 | 7 December 2023 to 30 August 2026 | Passed |
| Addendum 1 | RT35-1-2023 targets | Period ending 31 August 2026. Signed 30 August 2024 | Passed |
| Addendum 2 header | RT35-2023 pricing | 1 September 2023 to 31 August 2026 | Passed. Procedure schedule, not a device price |
A search on 1 October 2026 did not produce a National Treasury successor circular extending RT35-2023 or RT35-1-2023 past those dates. Absence from that search is not a certificate that no extension exists in a file this review did not open. It does mean Addendum 3 is not itself the extension.2
District indexes are a separate fact, and they do not restart the national term. On the KwaZulu-Natal Department of Health supply-chain pages, read the same day, the index lines were:8910
- June 2026 adverts: Umzinyathi District Office, "circum Q vmmc packs", advertised 24 June 2026 and closing 29 June 2026. Harry Gwala District Office, "Surgical Kits For Circum Q Device", advertised 2 June 2026 and closing 5 June 2026.
- July 2026 awards index: Umzinyathi District Office, "Supply and deliver Circum Q VMMC Packs", dated 13 July 2026.
- August 2026 adverts: eThekwini Metro, "customised surgical kit for use with the circum Q Device", advertised 31 August 2026 and closing 4 September 2026. The same index has a separate line, "Surgical kit for dorsal slit method", with the same advert and closing dates.
The linked PDFs were not opened. An index line is not a completed national award, not a price, and not proof that RT35 was extended. The eThekwini closing date of 4 September 2026 falls after both 30 August and 31 August. That is a reason to ask what authority the district is using. It is not a reason to treat Addendum 3 as still in force, and it does not override paragraph 10.1 for ages 10 to 14.110
Why the invalidity finding is not a clinical danger finding
Paragraph 124 is the unlawfulness conclusion: the award of tender RT35-2023 to CircumQ was unlawful and invalid. The sentence that separates process from clinical danger is paragraph 131, not paragraph 124.1
They are, however, irregularities in process and verification, not findings that the CircumQ device is, in fact, clinically dangerous, or that its use has caused systemic harm in all segments of the patient population for which some level of evidence exists.— Unicirc (Pty) Ltd v Minister of Finance and Others [2026] ZAGPPHC 444, paragraph 131
The same paragraph gives the two process grounds. The evaluators did not verify whether CircumQ was still in active pursuit of WHO prequalification at the time of bid evaluation. The bid evaluation committee accepted an unverified Class A classification. The court then records Gauteng provincial implementation data: a total adverse-event rate of 0.65 percent across 3,560 procedures, with all recorded adverse events classified as mild, and with no split by age. That is the court's description of a provincial report. This review did not recompute it, and a passive count of this kind is not an incidence rate or a cause-and-effect finding. The judgment does not print a count of 23 events, and it does not describe those events as wound oozing or oedema.1
Paragraph 132 is the other half of the remedy. The court says no case was made out that CircumQ is more harmful, or carries materially greater clinical risk, than dorsal slit, and that the Director-General recorded a WHO warning about adverse effects of the dorsal slit method as a reason the bid was developed. Setting the entire contract aside, the court says, would revert VMMC procedures to dorsal slit, and for the 15-and-above group that outcome may do the contrary of advancing health and safety. Paragraph 10.3 can therefore name dorsal slit as a method a provider may use for ages 10 to 14 without the court having appointed dorsal slit as the programme method for every age.1
The court refused to admit the further affidavit of Ms C.G. Yeko. She is a registered nurse. The affidavit describes a reported serious postoperative complication in a 10-year-old boy after a circumcision said to have used CircumQ. She did not witness the procedure, the practitioner and patient are unidentified, and paragraph 89 calls the evidence hearsay in its essential respects. The refusal means that affidavit is not part of the evidence the order rests on. It is not a finding that the reported event did not happen, and it is not a finding that the device is safe.1
Unicirc did not submit a bid and did not participate in the tender in its own name. Access Medical (Pty) Ltd bid with the intention of using a Unicirc device and was disqualified at the technical evaluation phase for failing to provide WHO prequalification documentation or evidence of a pending application. The order does not award the tender to Unicirc or to Access Medical. CircumQ, the successful bidder, did not participate in the review.1
Prequalification, the TAG note, and a Class A label
The judgment turns on a tender rule that a surgical aid be WHO-prequalified or actively in that process, and on a Class A label the committee did not investigate. Those are not the same document. Five labels get confused in supplier files.15
- A WHO prequalification outcome is a published result of WHO's own assessment. The court's paragraph 103 says that, on the record before it, CircumQ "remains unapproved" and that there were no public records showing the further studies had been completed or that the device was being assessed. That is the court's word for the status on the review record. It is not a new roster this page compiled. For how to read the public list, use the separate buyer guide on whether a circumcision device holds WHO prequalification.16
- The judgment's account of the WHO Technical Advisory Group report dated 29 June 2021 is a recital, not a fresh opening of that report. Paragraph 100 says the device was not outright rejected and was not cleared to move forward. The TAG advice recorded there has four parts: more independent safety data from a comparative trial or a case series of at least 2,000 placements; a follow-up TAG review before any prequalification decision; a formal instructions-for-use document; and bridging studies for males under 18, before or after prequalification, to demonstrate safe use under 18. Paragraph 103 says the record did not show that this process was still active at evaluation.1
- WHO eligibility of a device type is not prequalification of a brand. On the eligibility table updated 25 September 2026, male circumcision devices are listed for HIV prevention in high-incidence, low-circumcision settings. The note requires that clinical studies have been presented to the Technical Advisory Group on Innovations in Male Circumcision and that the group has issued a positive recommendation. A further priority note says products previously submitted to UNFPA, together with CAD-TB products and male circumcision devices, will be eligible for WHO assessment beginning 1 October 2026. That date is the start of an assessment wave for the device type. It does not place CircumQ on a prequalification list, and a 2021 TAG conclusion that did not clear the device to move forward is not the positive recommendation the note describes.15
- Class A on this record is the label in the special conditions and in the bid, not a class the court assigned. The special conditions required a non-invasive Class A surgical aid. Unicirc argued the device ought to have been Class B. The court held that awarding the tender on an unverified Class A assertion, without the committee investigating it, was irrational and unreasonable. The court did not issue a SAHPRA reclassification. Paragraph 122 says a SAHPRA licence authorises manufacture, importation, distribution, or wholesaling. It does not, by itself, verify the classification. ISO 13485, in the same paragraph, certifies a quality management system, not the correctness of a class.1
- An establishment licence and a quality-system certificate answer a company-level question. They do not answer whether this model completed WHO prequalification.1
| Label | What it can show | What a buyer should not treat it as |
|---|---|---|
| WHO prequalification public report | WHO has published an assessment outcome for the named device | An application, an eligibility category, or a 2021 TAG meeting |
| TAG recommendation | On this judgment's recital, the 29 June 2021 report did not clear CircumQ to move forward and asked for more data, a later review, an instructions-for-use document, and under-18 bridging studies | A positive recommendation, or proof that those steps later closed |
| WHO eligibility table, updated 25 September 2026 | Male circumcision devices are an eligible type, and from 1 October 2026 they are in an assessment wave, if the TAG note is met | Prequalification of CircumQ |
| Class A label in the bid | The class the tender asked for and the class the committee accepted without the investigation the court required | A court finding that SAHPRA has reclassified the device, or that every clamping circumcision device is Class II |
| SAHPRA establishment licence or ISO 13485 | Authority to manufacture, import, distribute, or wholesale, or a quality-system certificate, as the court distinguished those papers | Verification of the device classification, or WHO prequalification |
Incoming document checklist
Use this when a provincial memo, a district requisition, or a supplier letter cites RT35, CircumQ, or Addendum 3.
- Identify the paper. Addendum 3 is the 25 September 2024 circular on RT35-1-2023. The order is [2026] ZAGPPHC 444, delivered 7 May 2026. A news reprint of the GroundUp story is not the order.127
- For males aged 10 to 14, do not use Addendum 3 or section 5.10.1 as authority to require CircumQ. Paragraphs 10.1 and 10.2 restrain the respondents from enforcing that mandate and from requiring, directing, or obligating providers to use the device. Paragraph 10.3 tells provincial departments to leave the provider free to use a clinically appropriate method, including dorsal slit or another method the department considers appropriate on the clinical evidence.1
- For males aged 15 and above, section 5.10.2 is the preference clause, and paragraph 11 kept it only until the court's expiry formula or earlier lawful termination. Do not copy the 10-to-14 interdict onto this age band, and do not copy the 15-and-above clause onto boys aged 10 to 14.1
- Write down which end date the file is using: 20 April 2026 under the court's 36-month formula, 30 August 2026 on Addendum 3, or 31 August 2026 on Addendum 1 and the Addendum 2 header. On 1 October 2026 those dates had passed. Ask for any later signed Treasury circular rather than inferring one from a district advert.123410
- If the dossier says Class A, WHO-eligible, or ISO 13485, separate those labels using the table above. Ask for the classification record the committee was supposed to examine, and for a WHO public-report reference if prequalification is claimed. Do not assign CircumQ a new class from this judgment. The court did not.15
- Do not treat Unicirc, Access Medical, or any device absent from the order as the supplier the court appointed. The order restored a limit on the mandate. It did not award a substitute contract.1
Frequently asked questions
Did the High Court find that CircumQ is clinically dangerous?
No. Paragraph 131 says the grounds are irregularities in process and verification, not findings that the device is clinically dangerous or that its use caused systemic harm in all segments of the patient population for which some evidence exists. The Gauteng figure in that paragraph is 0.65 percent across 3,560 procedures, all recorded events classified as mild, not split by age. Paragraph 132 says the papers did not show CircumQ to be more harmful than dorsal slit. None of those sentences is a judicial certification of safety or of WHO prequalification.1
Did the court replace CircumQ with Unicirc or with dorsal slit?
No. Unicirc did not bid in its own name. Access Medical was disqualified at technical evaluation for lack of WHO prequalification documentation or evidence of a pending application. Paragraph 10.3 names dorsal slit as one method a provider may use for ages 10 to 14. Paragraph 132 says a full return of the programme to dorsal slit was a reason not to set the whole contract aside at once, particularly for males aged 15 and above.1
If a clinician prefers CircumQ, may a clinic still require it for boys aged 10 to 14?
The order stops the respondents from enforcing section 5.10.1 and directs them not to require, direct, or obligate providers to use CircumQ for that age band. It tells departments to leave the provider free to choose a clinically appropriate method, including dorsal slit or another method the department considers appropriate on the clinical evidence. It does not name CircumQ as that method. Separately, supply still needs a contract that is in force. The end dates checked on this page had passed by 1 October 2026.1234
Can the order be ignored because the term has expired?
No. Paragraph 9 still declares the 20 April 2023 award unlawful and invalid, and paragraphs 10.1 to 10.3 still state the limit on section 5.10.1. Expiry explains why the court did not unwind the whole performed contract. It does not revive Addendum 3. A new tender or a signed extension would be a new document. This review did not find that document.1
Where VEMERIX fits—and where due diligence still begins
VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care. The public catalogue includes circumcision devices that are not the device named in RT35.11
- The circumcision device page records a Class II single-use biodegradable ring, NMPA registration Lu Mech Reg. 20172020238, and a CE mark. The anastomat kit page records Class II registration Lu Mech Reg. 20162020372. The sterile circumcision device page records Class II registration Lu Mech Reg. 20222021157. The circumcision stapler page records Class II registration Lu Mech Reg. 20192020192 and describes resection and anastomosis in one motion. Those are Chinese Class II catalogue entries. They are not the Class A surgical-aid label in the RT35 special conditions, and this page does not argue that one label satisfies the other.11121314
- None of those pages is named in the 7 May 2026 order, and the order does not appoint them as a replacement for CircumQ. VEMERIX does not supply CircumQ.111
- The quality page states ISO 9001 and ISO 13485 quality systems and points readers to registration documents and those certificates. That is a company quality-system statement. On the court's own distinction, an ISO 13485 certificate does not verify a device classification and does not prequalify a model.115
For a new specification, the useful request is the registration certificate and the quality documents the manufacturer will supply for the named SKU. Ask for them through the contact page. The WHO list check remains the separate guide linked above.615