GBA medicine and device access: a patient planning guide

What GBA medicine and device access refers to

Guangdong’s regulation covers the institutional import and clinical use of clinically needed Hong Kong and Macao medicines and medical devices by designated institutions in the mainland cities covered by the GBA framework. An ordinary consultation in Hong Kong follows a different route. For a product found on a Hong Kong website, ask a designated mainland institution whether it can assess the proposed use through this framework.

Start by asking which pathway the receiving institution is actually proposing. Is the enquiry about its ordinary clinical services, use under the Hong Kong–Macao framework, or a separately described research activity?

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Distinguish the medicine rules from the device rules

The regulation describes clinically needed medicines already marketed in Hong Kong or Macao. For devices, it also refers to procurement and use by Hong Kong or Macao public hospitals and clinical advancement. These descriptions should not be flattened into a claim that anything sold across the border can be requested by anyone. The product and its intended clinical use need to be identified.

The 2025 catalogue, issued in a notice dated 28 January 2026, contains 115 entries: 45 medicines and 70 medical devices. It replaces the 2024 catalogue and directs designated institutions to the catalogue procedure for listed products. The official text is also available from Hong Kong’s Trade and Industry Department. Match the exact product to the latest official publication, then ask the institution about stock, an appointment and individual suitability; catalogue inclusion leaves those matters unresolved.

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A designated hospital is the beginning of the check

The fourth-batch notice dated 5 December 2025, published on Guangdong’s regulator website on 26 December, adds 27 designated medical institutions and removes one. Designation can therefore change. Hong Kong’s published hospital list includes Foshan Fosun Chancheng and Guangzhou Xinshi. The exact campus and product scope still need to be identified: match the legal hospital name and location to the latest official list, then ask that institution about the proposed product arrangements.

Use a hospital profile to find the institution, then ask for the legal name and exact site handling your enquiry. Ask about its current designation and relevant product arrangements. A group’s report about introducing medicines in several cities gives context for the enquiry, while approval, supply and appointments remain specific to each institution. Keep the reply for the site you intend to visit alongside its full name and address.

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Clinical assessment remains individual

The regulation requires use within the appropriate indications and clinical standards, explanation of mainland alternatives and informed consent. Ask what records the team needs to assess the diagnosis, previous treatment and proposed product.

A useful discussion should allow the patient to ask how the proposed option relates to alternatives and what further information is needed. Consider preparing questions in the patient's preferred language and confirming how answers will be explained.

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Turn the enquiry into a staged travel discussion

Before committing to travel, ask what can be clarified from the initial information and what needs an in-person assessment. Which institution is taking responsibility for the next step?

Compare the proposed product with the current catalogue by name, specification or model, holder and indication or intended use. Management rules effective from 1 November 2025 require dynamic updates, including removal when a medicine or device gains mainland marketing approval. Take the matched product details to the hospital and ask about its current pathway, institutional import and supply, individual clinical review, and the appointment arrangements that would inform your travel dates.

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Ask about monitoring, payment arrangements and handover

The regulation includes safety monitoring and circumstances in which use may be suspended. Ask the hospital who would explain follow-up responsibilities and how later questions should be directed. If you expect to return to another country, ask what information your doctor there would need and whether the receiving institution can provide an appropriate summary. Do not assume that a later product enquiry can be handled by a different campus.

Guangdong’s regulation encourages insurance products covering this area; individual policy coverage remains a separate question. Ask the hospital and insurer which documents or prior confirmation each requires. Keep payment administration separate from the clinical decision, and ask about language support, accompanying-person needs and communication channels for your visit. Record the practical arrangements each party can make, since the policy framework and group announcements leave these visit-specific questions open.

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Keep treatment access separate from research and export

The regulation separately discusses real-world research. That does not turn the access pathway into an invitation to a clinical trial, or mean that a treatment enquiry includes research participation. If research is mentioned, ask the institution to explain that activity distinctly and what decision is being requested from the patient.

The framework concerns institutional import and clinical use. Personal export, take-home supply and international delivery require their own permission and arrangements; they are outside what this pathway establishes. For families returning to Southeast Asia, the Middle East or Africa, begin with the clinical handover. Ask how the treating teams can communicate about continuing care before making any plans to transport a product across borders.

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Prepare an enquiry for HKU–Shenzhen Hospital

HKU–Shenzhen Hospital publishes information on the GBA medicine and device access programme. Prepare the product name and the clinical question, then contact The Treat for help arranging a consultation.

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