Hospital Authority Procurement and Form MD111 in Hong Kong, China

1. Key takeaways

Since 2024 the Hospital Authority has operated an enhanced procurement strategy that gives priority to medical devices already listed under the Medical Device Administrative Control System (MDACS). In support of that strategy the Medical Device Division (MDD) provides Form MD111, the supplementary information form for Hospital Authority procurement of medical devices. For the public healthcare system in Hong Kong, China, listing has moved from a bonus to an entry threshold. Because the public system serves the great majority of patients, the commercial space for unlisted products is being systematically compressed.

• Two procurement lines run in parallel and should not be conflated: the Department of Health line, where Stage C makes listing mandatory, and the Hospital Authority line, where the strategy is expressed as a priority.
• MD111 is a dedicated supplementary form for Hospital Authority procurement. It sits outside the MDACS listing application and is managed separately.
• The direction of travel was set in 2023, when the priority procurement strategy was fully implemented. The current tightening is the execution of an established route, not an improvised policy.
• The Hospital Authority strategy is being implemented in phases across public healthcare facilities, so timing differs by institution.
• There is a documented link to the Hong Kong and Macao medicine and medical device connect scheme: a device already procured and used by public hospitals in Hong Kong, China can support a later route into the Greater Bay Area.

2. Legal basis

The Hospital Authority requirement is described in government press releases and operationalised through Form MD111, while the Department of Health requirement sits in the Stage C procurement rules. Regulatory information was verified as of 29 October 2026; if an official document has since been updated, the latest published version prevails.

The table shows a division of labour rather than a duplication. The Department of Health sets the rule for its own procurement and states it as a requirement. The Hospital Authority sets its own strategy and states it as a priority. Both point to the same register, which is why a listing serves both lines even though only one of them makes it mandatory in terms.

3. Expert insights

Insight one: the Department of Health and the Hospital Authority are two different procurement lines. The Stage C rule of the Department of Health is mandatory: the device must be listed. The enhanced procurement strategy of the Hospital Authority is expressed as giving priority to listed devices. The strength of the two formulations differs, but the direction is the same, and listing is the common precondition for entering public sector procurement. A supplier that satisfies the Hospital Authority expectation but not the Department of Health rule will still be excluded from the Department of Health line, and the reverse is equally true in practice, because a product without a listing is a product without a verifiable status.

Insight two: the government began laying this path in 2023. The government response of 15 January 2024 explains that the Department of Health has, since June 2023, fully implemented the strategy of giving priority to the procurement of listed medical devices, and that it established a working group with the Health Bureau and the Hospital Authority to drive the phased implementation of similar procurement arrangements across public healthcare facilities under the Hospital Authority. This shows that the present tightening is the execution of an established route rather than a temporary policy. For planning purposes it also means the direction is unlikely to reverse, which is the assumption on which capital and time should be committed.

Insight three: MD111 is a dedicated supplementary form for Hospital Authority procurement. It exists independently of the MDACS listing application and is used to collect supplementary device information within the Hospital Authority procurement process. Companies should manage it separately from the listing certificate (practical estimate). The reason is practical: the listing file is a regulatory document controlled by the regulatory function, whereas MD111 is a procurement document controlled by the commercial function, and the two are updated on different cycles for different audiences.

Insight four: the route connects to the Hong Kong and Macao medicine and medical device connect scheme. One of the device conditions under that scheme is that the device has already been procured and used by public hospitals in Hong Kong, China. Entering the Hospital Authority procurement system first, and then using that position to enter the Greater Bay Area, is a route with an official basis. The sequencing matters: the public hospital use is the evidence, so it cannot be created retrospectively once an application for the Chinese mainland is being prepared.

Insight five: the phased implementation creates uneven requirements across institutions. Because the arrangements are being implemented in phases across Hospital Authority facilities, two hospitals may apply the expectation differently at the same point in time. A supplier should therefore confirm the position with each institution rather than assume a single national rule. The listing remains the constant; what varies is the point at which a given facility insists on it.

4. Practical recommendations

• Treat Hospital Authority procurement as a target of the listing plan. Under the priority strategy, listing should be treated as the base action for entering the public system.
• Prepare a separate MD111 pack. Manage it apart from the MDACS listing file and submit it in line with the Hospital Authority procurement timetable.
• Track the phased implementation. The government has stated that facilities under the Hospital Authority are implementing similar arrangements in phases, so the expansion should be followed over time.
• Connect to the Greater Bay Area route. For products already procured by public hospitals, assess the possible application of the Hong Kong and Macao medicine and medical device connect scheme.
• Check validity against the procurement cycle. Confirm that the listing certificate remains valid for the whole period over which supply is expected.

5. Verification checklist

• □ The current version of Form MD111 has been obtained
• □ MDACS listing has been completed, as the precondition for Hospital Authority priority
• □ The MD111 pack is managed separately from the listing file
• □ Progress of the phased implementation of the Hospital Authority strategy is being tracked
• □ The opportunity under the Hong Kong and Macao medicine and medical device connect scheme has been assessed
• □ The listing certificate validity covers the procurement cycle
• □ The requirement position has been confirmed with each target institution

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