Does This Circumcision Device Hold WHO Prequalification?

Contents: What changed on 25 September 2026 · Which names are on the list file · Catalogue codes and sizes · Manufacturing site and inspection · Accessories and rebrands · National registration · Accept-or-send-back checks · Where VEMERIX fits · FAQ

What Did WHO Change for Circumcision-Device Prequalification on 25 September 2026?

On 25 September 2026 WHO announced an expansion of its prequalification programme for medical devices. The news item says male circumcision devices are now part of the broader medical-device prequalification framework, whereas they were previously assessed under a separate process. The same announcement moves prequalification of male and female condoms and intrauterine devices from UNFPA to WHO, and it brings computer-aided detection software for tuberculosis into the programme. It also points readers to further information on the transition and a first assessment wave for contraceptive devices, CAD-TB products, and male circumcision devices. It does not name a newly prequalified circumcision device. ¹

The about page dates this medical-device chapter to 25 September 2026 and says WHO began prequalifying male circumcision devices in 2011–2012, building on existing in vitro diagnostic prequalification. Its scope list is male latex condoms, female condoms, IUDs, CAD-TB software, and male circumcision devices previously assessed under a separate process. ² The 25 September date is the framework date. It is not the first day WHO assessed a circumcision device, and it is not a new line on the list file.

The news item says WHO-prequalified devices support voluntary medical male circumcision services, which can reduce men's risk of acquiring HIV through heterosexual exposure by approximately 60 percent. ¹ That sentence describes the services. It is not a score that ranks ShangRing against another device, and it is not a result computed for this page.

A quotation that treats the 25 September 2026 announcement as automatic prequalification of a different ring, anastomat, or stapler is not supported by the news text. The announcement does not say that dossier review or site inspection was waived. The list file checked the next day was still the one-page roster last updated 24 July 2020. ^{1 3}

Which Product Is on the List File, and Which Names Are Not?

The directory page says the list contains male circumcision devices for adult male populations, appropriate for use in resource-limited settings, and it links the list document. It does not print the product row. ⁴ The file opened from that link on 26 September 2026 is a one-page PDF. Its title is 19 05 21 PQMC list prequalified_devices.xlsx. The printed header is Last updated: 24 July 2020. The PDF metadata records a modification on 23 October 2020. Use the printed header as the roster date, not the metadata modification date. The page ends after one product row. ³

That row, read with the opening of public report version 6.0, is: ^{3 5}

• Product name on the list: ShangRing.
• Public report identity: ShangRing (Generation II, self-locking model), Rest of World regulatory version, WHO reference PQMC 0003-003-00.
• Legal manufacturer: Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
• Type on the list: collar clamp.
• Catalogue numbers: SR-II-40 through SR-II-9, 32 codes.
• Manufacturing site on the list: 4F Overseas Student Pioneer Park Science Innovation Center, Economic & Technology Zone, North Yinhu Road, Wuhu, China.
• Year prequalified: 2015.
• Footnote: the product was originally prequalified and the public report was amended. The footnote points to the public report for the amendments.

Version 6.0 uses two listing dates and does not collapse them. The opening sentence says the product was listed on 03 June 2015. The summary table says prequalification listing 5 June 2015, outcome listed. ⁵ Cite both if the tender file asks for the listing date. Neither date is a second product.

These counts are a reading of that PDF and of Table 1 on 26 September 2026. They are not a live database export. WHO can replace the file without changing the directory sentence. Clinical performance, adverse-event counts, and aftercare steps inside the public report are not restated here.

PrePex Is Not on the List File

PrePex does not appear on the 24 July 2020 list document. ³ On the prequalified medical devices page, the heading for devices delisted from the WHO prequalification list is followed by No delisted products. ⁹ Do not write an audit finding that says WHO published a delisting notice for PrePex. The finding the current files support is narrower: PrePex is not on the list file that the directory still links, and the delisting line does not name it either.

A 2016 paper states that PrePex was prequalified by WHO in 2013 for use in men aged 18 years and older, and it discusses PrePex and ShangRing as devices that were prequalified at that time. The corresponding author was in WHO's Department of HIV and AIDS. The paper says the views expressed do not necessarily represent the authors' institutions. ¹⁰ Use that sentence as history. Do not use it as the roster checked on 26 September 2026.

This site's 17 August 2026 registration evidence pack says that, to date, only PrePex and ShangRing have achieved WHO prequalification. That sentence is not what the list file opened for this check shows. The evidence pack still owns the US, EU, and China classification matrix. This page owns the current-list identity test and does not rebuild that matrix.

A same-day search for the query still returns the WHO directory, the eligibility page, older ShangRing report landings, 2015 news, and papers about PrePex. Those results explain why a bidder may attach an old clip. They do not add a row to the list. People Also Ask on that search is about consumer circumcision questions. This page does not answer those questions.

The prequalified medical devices page, which is a different page from the one-row circumcision list file, says that list is not an exhaustive list of medical devices available for use. It also says that leaving a product or supplier off the list does not mean the product would fail to comply if it were assessed, evaluated, and tested. Inclusion does not imply WHO approval of the product or the manufacturing site. National authorities decide approval. ⁹ A tender can still require the circumcision list file. Failing that commercial gate is not a safety ranking.

Which Catalogue Code and Size Have to Match the Quotation?

Prequalification on this file attaches to the codes in Table 1 of version 6.0, not to the brand name alone. The table lists 32 rows. Inner diameters run from 40 mm to 9 mm in 1 mm steps. The letter codes are not A4, B4, C4 and so on. They are A4, A3, A2, A1, and A for 40 mm through 36 mm, then B through Z for 35 mm through 11 mm, then Z1 and Z2 for 10 mm and 9 mm. ⁵ The 24 July 2020 list uses the same letter-to-diameter pairs in its packaging column. ³

A quotation that pairs SR-II-39 with the letter B4 does not match Table 1. SR-II-39 is A3, 39 mm. There is no SR-II-9.5 and no 9.5 mm row. A code outside SR-II-40 through SR-II-9, or a diameter outside 40 mm through 9 mm, is outside this table.

The version 2.0 row in that amendment table is dated 3 July 2018 and lists five changes. The fifth is "Making Available and Using Every Other ShangRing Size." The fourth records eligibility for use from the then-current 13 years of age to 10. The pages used for this check do not define the every-other-size line further. Table 1 in the same version 6.0 file still lists all 32 codes above. Do not treat that title as permission to add a diameter that Table 1 does not contain. ⁵

The directory still describes the list as devices for adult male populations. ⁴ Inside version 6.0, the manufacturer's intended-use statement says the device is indicated for ages 13 and older with the flip technique or the no-flip technique, and for ages 10 to 12 only with the no-flip technique, and that local anaesthesia is necessary. ⁵ This page does not resolve that tension by rewriting eligibility, and it does not restate placement, removal, or aftercare steps. If the tender population is outside the statement in version 6.0, that mismatch is a file question for the buyer, not a new indication created here.

Where the tender does not use this WHO list, size assortment is a different decision. The disposable circumcision device sizing buyer guide covers size portfolios for devices that are not this WHO row.

Does the January 2026 Public Report Move the Manufacturing Site?

Version 6.0 is dated 30 January 2026. Its version 6.0 amendment says: "The addition of a new manufacturing site built by SNNDA aims to increase production and delivery capacity, improve production logistics, and enhance the overall work environment." ⁵ That cell does not print a second street address. The device-description sentence places the company in Wuhu, Anhui Province. That is not a second street, and it should not be pasted onto the Pioneer Park line as if the list had printed the province.

The street line that the list and the inspection report do print is:

Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd., 4F Overseas Student Pioneer Park Science Innovation Center, Economic & Technology Zone, North Yinhu Road, Wuhu, China.— WHO list of prequalified male circumcision devices, last updated 24 July 2020. The inspection report uses the same street and adds People's Republic of China.

Label artwork reproduced inside version 6.0 uses closely related wording, including "Science Innovation Centre" and either "YinHu Road" or "Yin Hu Road." Those label lines do not print the word "North." They are label lines in the same report, not a second city. A quotation that names a different city cannot be confirmed from these files. ⁵

Any UN organization that uses the list for procurement is told to ensure that only products from the manufacturing sites mentioned in the list are supplied. ⁹ The public report's inspection section uses "site(s)" and does not add a street for the version 6.0 site. Until WHO prints that address, a second street on a quotation is unverified.

The WHO public inspection report for this manufacturer was created on 20 November 2025. Read the header fields, not a shortened date range: ⁶

• Inspected site address: 4F Overseas Student Pioneer Park, Science Innovation Center, Economic & Technology Zone, North Yinhu Road, Wuhu, People's Republic of China.
• Dates of inspection: 29 July to 1 August 2024 and 26–27 May 2025.
• Type of inspection: re-inspection. Do not relabel the type field as a separate commissioning inspection.
• Header: the form is labelled "In-vitro Diagnostic product." The scope line is PQMC-0003-003-00 ShangRing. That header is the report template, not a different device.
• History: a routine inspection of the site occurred from 29 July to 1 August 2024, and on 26–27 May 2025 an inspection was performed to inspect the commissioning of the new QC and manufacturing facility. The report does not print a second street for that facility.
• Scope: PQMC-0003-003-00 ShangRing.
• Criteria: ISO 13485:2016 and WHO prequalification-specific requirements.
• Previous WHO inspection: June 2019, found compliant.

A quotation that cites only 26–27 May 2025 is incomplete against this report. It is not, by itself, proof that the goods came from a different factory. For supplier identity beyond this WHO row, use the circumcision device manufacturer identity check. That guide's inspection citation shortens the window. This page keeps both date ranges.

Are the Bandages and Removal Tools Part of the Prequalified Device?

Version 6.0 describes the ShangRing as a sterile, single-use device of two concentric plastic rings, the inner ring lined with a silicone pad, in 32 sizes. The warnings say not to use the device if the patient is allergic to silicone or Lexan (polycarbonate). The report says the device has been sterilized by gamma irradiation and has a shelf life of three years. Store it in the original package at or below 80 percent relative humidity, from 5 °C to at or below 50 °C. The shelf-life footnote says the finished-goods shelf life, counted from packaging completion, may be shorter than the shelf life counted from manufacture. ⁵

Read three statements together. Version 6.0 does not retire the sold-separately sentence when Table 2 prints order ratios.

• List file, last updated 24 July 2020: one unit is recorded for each listed size, plus "Measuring tape x1." Bandages, the removal cutter, and the removal key opener are sold separately. ³
• Public report version 6.0, device description: the measuring tape is supplied with the device and is supplied non-sterile. Bandages, the removal cutter, and the removal key opener are sold separately. Any general surgical dressing can be used. The removal cutter and removal key opener are reusable and must be cleaned and sterilized, or cleaned and disinfected, before each patient use. ⁵
• Public report version 6.0, Table 2: with each order of 200 ShangRing units, 1,400 bandage pieces, 4 removal-cutter-and-key sets, and 200 measuring tapes are provided. Additional pieces can be purchased separately. ⁵

The prequalified device in these files is the ShangRing collar clamp, not a bandage-only line and not a removal-tool-only line. A quote for dressings or removal tools alone does not become a WHO-prequalified device supply because the ratios above exist.

Rebranded and Private-Label Products

Applications are accepted only from the legal manufacturer of the product. ⁷ The eligibility page's rebrand rule is specific:

WHO considers a rebranded product to be one that is manufactured under identical conditions at the same manufacturing site(s) as the original product. In other words, a rebranded product is identical in every respect (including the intended use) to the product manufactured by the original manufacturer, except that the product is labelled with the rebranded product name and product code, and bears the rebrander's name or brand. Rebranded products are outside the scope of prequalification, however, and not accepted for prequalification assessment.— WHO, Male circumcision devices eligible for prequalification, rebranded-products section, read 26 September 2026

The same section says WHO is aware that some manufacturers purchase finalized products from other companies and place them on the market under their own name or brand, and that such products are also known as original equipment manufacturer products. An ISO 13485 certificate or a supply contract does not put a different brand onto the list. If the tender requires the prequalified device, the label has to be the listed name and the legal manufacturer has to be the listed manufacturer. ⁷

Does a WHO Listing Replace a National Registration?

The news item describes prequalification as guidance for United Nations agencies, procurement organizations, donors, and national authorities. ¹ The list page says the products have been found acceptable, in principle, for procurement by UN agencies. It also says inclusion does not imply any approval by WHO. Approval is for national authorities. ⁹

Inclusion in this list does not constitute an endorsement, or warranty of the fitness, by WHO of any product for a particular purpose, including in regard to its safety and/or efficacy.— WHO list of prequalified medical devices, disclaimer point 1, read 26 September 2026

Disclaimer point 2 says WHO does not warrant that the products listed have obtained regulatory approval for their specified use, or any other use, in any country, or that their use accords with national law, including patent law. ⁹ A WHO listing is not an FDA clearance, a CE mark, an NMPA registration, or a Mexican sanitary registration. The Mexico market-placement guide shows that point for COFEPRIS. Class and evidence for the United States, the European Union, and China are in the registration evidence pack. Product-specific prequalification is a separate check from a general consumable specification, which is the point of the public procurement specifications guide.

Version 3.0 of the ShangRing public report, dated 22 March 2019, records notification of CE marking and the Rest of the World regulatory version. ⁵ That is an amendment line in the WHO file. It is not a CE certificate inspected for this page, and it does not turn the 2015 listing into an EU marketing authorization.

The procedures page says prequalification fees are non-refundable and that payment does not guarantee that the product will be prequalified or that it will keep that status for any minimum time. Failure to pay within the defined timeline will cancel an assessment application or a change-request application, or will suspend prequalification status, whichever applies. WHO reassesses listed products and sites at an interval it sets with a risk-based approach. If reassessment finds that the product or site no longer meets requirements, the product is removed. If the manufacturer does not participate, the product is delisted. ⁸ The same page prints US$ 5000 for dossier screening, US$ 12,000 for product assessment, and a change-assessment fee of US$ 3000 that WHO may waive case by case. It then prints an annual fee of US$ 4000 for each product on the WHO list of prequalified male circumcision devices, and the next sentence says that annual fee applies to all IVDs that, by 1 September of that year, have been listed for 12 months or more. Those two sentences do not describe the same product class, so US$ 4000 is not a settled circumcision-device invoice rule. The separate fee PDF dated 15 April 2019 was not opened. These figures are the HTML page as read on 26 September 2026. ⁸

The list page says WHO may suspend or delist a product for specified post-qualification failures, including failure to allow inspection or serious nonconformities, and that a manufacturer may withdraw a product or a site with prior written notice. ⁹ "May" is the word on the page. It is not an automatic outcome for every gap in a bidder's folder.

Accept-or-Send-Back Quotation Verification Framework

Use one row of the quotation against one public file. If the cell does not match, send the line back. Do not repair it from a news clip or from an ISO certificate.

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 circumcision device product page describes a self-detaching circumcision ring for adult and pediatric use. It records Class II, NMPA registration Lu Mech Reg. 20172020238, CE, ethylene oxide sterilization, individual sterile blister packs, adult and children types, and 14 size codes. ¹¹ Those are catalogue statements. They are not on the WHO list file, and they are not a clinical comparison with ShangRing.

The circumcision anastomat kit and the circumcision stapler are separate registrations. The 14 size codes and the CE line on the circumcision-device page do not transfer to them. None of those products appears on the WHO list read for this article. ³

If the tender requires a product on the current WHO prequalification list, a VEMERIX quotation does not pass that line. The listed match is ShangRing from Wuhu Snnda, on the codes and site above. If the tender does not require that list, this check is finished. The next files are the destination registration and the product page, not a claim that absence from the WHO list is a quality finding. The prequalified medical devices page says absence from that list does not mean a product would fail to comply if it were assessed. ⁹

For a registration pack, sample, or distributor discussion outside a WHO-list line, use contact and the circumcision device page. Ask for the certificate and registration that match the SKU being offered.

Frequently Asked Questions

Is PrePex on the current WHO list of prequalified male circumcision devices?

No. PrePex is not on the list file last updated 24 July 2020. ³ The delisting line on the medical-device list says no delisted products. ⁹ A 2016 paper states that PrePex was prequalified in 2013 for men aged 18 and older. ¹⁰ That paper is not a current listing or a delisting notice.

Did the 25 September 2026 announcement add a second circumcision device?

No product name was added by the news item. It moved male circumcision devices into the broader medical-device prequalification framework, alongside the condom and IUD move from UNFPA and the addition of CAD-TB software, and it pointed to a first assessment wave. ^{1 2} The list file checked on 26 September 2026 still had one row. ³

How many ShangRing sizes are in the prequalified range?

Thirty-two. Catalogue numbers SR-II-40 through SR-II-9 correspond to 40 mm through 9 mm. The letter codes in version 6.0 Table 1 run A4, A3, A2, A1, A, B through Z, Z1, and Z2. They do not run B4, C4, D4. There is no 9.5 mm code. ⁵

Does a rebranded or private-label ring inherit ShangRing's prequalification?

No. The eligibility page says a rebranded product is identical in every respect, including intended use, except for the rebranded name, product code, and the rebrander's name or brand, and that such products are outside the scope and not accepted. Applications are accepted only from the legal manufacturer. ⁷

Does WHO prequalification authorize sales in a country?

No. Disclaimer point 2 says WHO does not warrant that listed products have regulatory approval in any country. ⁹ The destination authorization is a separate file.

Is a VEMERIX circumcision device WHO-prequalified?

No. It is not on the list file read on 26 September 2026. ³ The product page records CE marking and NMPA Lu Mech Reg. 20172020238 for that device. ¹¹ Those registrations are not this WHO gate.

Which public-report version should a 2026 tender cite?

Cite public assessment report version 6.0, dated 30 January 2026, WHO reference PQMC 0003-003-00, and say which table or amendment you are using. ⁵ For the inspection, cite both date ranges in the report created 20 November 2025: 29 July to 1 August 2024 and 26–27 May 2025. ⁶ Keep the list file's own date, 24 July 2020, visible, because that is still the roster document the directory linked on 26 September 2026. ³