Greater Bay Area Access Through the Hong Kong-Macao Medicine and Device Connect

1. Key takeaways

The Hong Kong-Macao Medicine and Device Connect scheme is the channel through which Hong Kong, China listing status extends into the Chinese mainland: pharmaceutical products already registered in Hong Kong, China and medical devices already procured and used by public hospitals in the city may, after approval by Guangdong province, be used in designated healthcare institutions in the Guangdong-Hong Kong-Macao Greater Bay Area for urgent clinical need. As at 30 September 2026, a cumulative total of 79 medicines and 100 medical devices had been approved for use in 71 designated healthcare institutions. The fourth batch of designated institutions was announced in December 2025.

• The direction of travel is from use in Hong Kong, China to use in designated mainland institutions, which is the reverse of a conventional registration strategy.
• For devices, the operative precondition is procurement and use by a public hospital in the city, not merely holding a listing.
• The scheme is administered in Guangdong, so the application is filed with the provincial authority rather than with a Hong Kong, China body.
• The designated institution list has expanded in batches, and each batch widens the population that can be reached.
• Listing on the Medical Device Administrative Control System (MDACS) and eligibility under the scheme are different tests, although in practice the first strongly influences the second.

2. Legal basis

The scheme rests on a national work plan for regulatory innovation in the Greater Bay Area and on provincial interim provisions that set out how applications are handled, with operational data published on a dedicated MDD page. The table below records the instruments relied on in this article.

The two layers have different functions. The national work plan establishes the policy framework, and the provincial interim provisions establish the procedural rules that an applicant actually follows. Reading only the policy document tends to understate the practical requirement, which is documentary proof of use in Hong Kong, China rather than a statement of intent to supply the region.

3. Expert insights

First, the channel runs from what is already used in Hong Kong, China to designated institutions on the mainland. Unlike a conventional registration strategy, the entry condition here is that a use history has already been established in Hong Kong, China. For devices, procurement and use by a local public hospital is the key condition. That means landing in Hong Kong, China first and then entering the Greater Bay Area through this route is a realistic sequence, and it is often more defensible than attempting to build a mainland presence without any local clinical footprint.

Second, the list of designated healthcare institutions keeps expanding. The first batch comprised 5 institutions: The University of Hong Kong-Shenzhen Hospital, Guangzhou Modern Hospital, Guangzhou United Family Hospital, Zhuhai C-MER Dennis Lam Eye Hospital and Zhongshan Chen Xinghai Hospital. The second and third batches were announced in February 2023 and September 2024 respectively, and the fourth batch was announced in December 2025, bringing the cumulative total to 71. Expansion of the list means the patient population that can be reached keeps rising, and it also changes the commercial case for filing in a given therapeutic area.

Third, the scheme is not the same thing as MDACS listing. The condition is that a device has been procured and used by a local public hospital, not that it has been listed. The two are nevertheless closely related, because public hospital procurement already gives priority to listed products, and for that reason listing is a de facto precondition for reaching the scheme (practical estimate). Treating the two as unrelated would be technically correct and commercially misleading.

Fourth, mainland regulatory coordination is intensifying. The authorities have stated that they will maintain cooperation with the Guangdong Provincial Medical Products Administration with a view to expanding the catalogue of medicines and medical devices that can be used as quickly as possible, and to extending the arrangement progressively to healthcare institutions in other Greater Bay Area cities that meet the requirements. For companies planning beyond a single product, that trajectory is as relevant as the current list.

4. Practical recommendations

• Treat Hong Kong, China as the first stop in a Greater Bay Area strategy. Complete listing first and seek public hospital procurement, so that the use history needed for a later application is accumulated.
• Track the designated institution list. Plan target institutions in step with each expansion batch, prioritising institutions that have already been approved.
• Prepare an evidence pack on use. Public hospital procurement records, usage volumes and clinical evaluation material should be archived systematically rather than assembled retrospectively.
• File in Guangdong. Applications for import and use of Hong Kong and Macao medicines and devices urgently needed for clinical use are accepted by the Guangdong Provincial Medical Products Administration and must be submitted according to the guidance on the Guangdong government service portal.

5. Verification checklist

• □ Confirmed whether the product has been procured and used by a public hospital in Hong Kong, China
• □ MDACS listing completed as a de facto precondition
• □ The latest designated healthcare institution list and batch number have been checked
• □ An evidence pack on public hospital procurement and use has been assembled
• □ The application entry point and material requirements of the Guangdong Provincial Medical Products Administration are understood
• □ Announcements on expansion of the catalogue are being tracked

Regulatory information verified to 29 October 2026. The legislation, guidance and effective dates described in this article are limited to what the official sources listed under Legal basis had published on that date; where an official document has since been updated, the most recent published version prevails.

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 MDACS listing applications across all risk classes, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com