Stage C Procurement: Listed Devices Required from March 2026

1. Key takeaways

The new rules under which the Department of Health strengthens the procurement of medical devices run in three stages: Stage A took effect on 21 June 2023, Stage B on 1 November 2024, and the Stage C enhancement on 23 March 2026. The requirements escalate. Stage B requires the applicable device to be already listed, or to have a listing application submitted with an application number issued before the tender closing date. Stage C raises the bar: the applicable medical device procured must be a listed medical device. Applicable devices are Class II/III/IV general medical devices and Class B/C/D in vitro diagnostic medical devices.

• Stage C removes the fallback that Stage B allowed. Submitting just before the closing date no longer preserves eligibility.
• Listing must be valid at the closing date, not merely obtained at some point. A listing that has lapsed is worse than a listing that has not yet been granted, because it looks compliant on a file cover.
• The supporting document has a prescribed form: a copy of a valid listing certificate bearing the Hong Kong Medical Device Listing Number.
• The schedule must be built backwards from the tender closing date, because the assessment and acknowledgement periods run in sequence and cannot be compressed by commercial urgency.
• Applicability is decided by class, so the first question is whether the device falls inside the Stage C scope at all.

2. Legal basis

The staged requirements appear in the Department of Health publication on the new procurement rules, with supporting descriptions on the MDACS pages, the notification list page and in GN-01. Regulatory information was verified as of 29 October 2026; if an official document has since been updated, the latest published version prevails.

The three stage dates are not a single reform but a sequence, and the sequence has a commercial logic. Stage A came into effect first, Stage B allowed a pending application to count, and Stage C closed that route. A supplier that built its tender calendar around the Stage B rule will find that the same calendar produces a disqualification under Stage C without any change in its own behaviour.

3. Expert insights

Insight one: the difference between Stage B and Stage C is one sentence, and the consequence is entirely different. Stage B accepted an application that had been submitted and given an application number; Stage C deletes that route. For a supplier, this means that the strategy of submitting just before the closing date fails completely under Stage C. The change is not a matter of degree. Under Stage B a supplier could bid while the assessment ran in parallel; under Stage C the assessment must be complete and the certificate in hand before the closing date.

Insight two: valid at the closing date is a stricter requirement than listed. Stage C requires the listing to be valid at the quotation or tender closing date. If a listing will expire during the contract period, renewal must be planned in advance through the renewal window, or the company may lose its compliant status partway through the contract (practical estimate). The exposure is easy to overlook because the bid is won on the strength of a certificate that was valid on the day of the bid, while the delivery obligation runs for years afterwards.

Insight three: the supporting document has a definite form. A copy of a valid listing certificate bearing the Hong Kong Medical Device Listing Number must be submitted. Evidence without the number does not meet the requirement, and this is the most frequent point lost in documentary review. A screenshot of a web entry, an approval email or a certificate from another jurisdiction may show that a listing exists, but none of them carries the number in the form the purchaser expects.

Insight four: counting backwards is the only reliable method. Taking the 12-week assessment plus 2 weeks for acknowledgement and allocation of the number, a start from zero requires approximately 14 weeks (practical estimate). The starting point for the count is the tender closing date, not the opening date. Suppliers commonly count backwards from the opening because it is the date in the calendar they are working towards, and then discover that the closing date has passed by the time the certificate is issued.

Insight five: the applicable scope is defined by class, and it excludes some products entirely. Applicable devices are Class II, III and IV general medical devices and Class B, C and D in vitro diagnostic medical devices. A Class I device or a Class A IVD falls outside the definition, which means the requirement does not apply to it. Establishing that a product is outside the scope is as valuable as establishing that it is inside, because it prevents unnecessary expenditure on a listing that the procurement rule does not require, while leaving the separate question of voluntary listing untouched.

4. Practical recommendations

• Build a backward schedule for each tender. Working back from the closing date, allow 14 weeks for assessment, 4 weeks for document preparation and 2 weeks for LRP and MDIS preparation.
• Obtain the LRP listing number early. The LRP is a precondition of the application and must be in place before anything else can be filed.
• Standardise the tender pack. Make the certificate copy bearing the HKMD Listing Number a standard annex that can be called up for every bid.
• Align listing validity with the contract term. Where a contract will run past the expiry date, plan renewal in advance within the 12-week to 1-year window.
• Confirm the class before committing. Check whether the product is an applicable device within the Stage C scope, and record the basis for the conclusion.

5. Verification checklist

• □ The product has been confirmed as an applicable medical device (Class II/III/IV GMD or Class B/C/D IVDMD)
• □ The HKMD Listing Number has been obtained
• □ A copy of the valid listing certificate is held as a standard tender annex
• □ The listing has been confirmed as valid at the quotation or tender closing date
• □ The submission date has been scheduled 14 weeks back from the closing date
• □ Renewal has been planned where the contract term crosses the expiry date
• □ The class determination and the basis for it are recorded in the tender file

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Hong Kong, China. Our team manages adverse incident reporting and recall coordination with the Department of Health, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com