5-Step Guide to the GBA Connect Scheme for Medical Manufacturers

Breaking into China’s healthcare market is structurally complex, but the GBA Connect Scheme offers a fast track. This policy allows designated hospitals in the Guangdong–Hong Kong–Macao Greater Bay Area (GBA) — home to over 87 million people — to use clinically urgent drugs and devices already approved in Hong Kong or Macao.

For international manufacturers, the scheme provides an opportunity to generate early revenue, collect real-world clinical data, and establish a foothold in China while national registration with the National Medical Products Administration (NMPA) is still in progress.

This guide walks you through how the scheme works, who it benefits, and the five practical steps overseas manufacturers can take to navigate the process successfully. For hands-on support with registration and hospital coordination, get in touch with Cisema for expert guidance at every stage.

Understanding the GBA Connect Scheme

The GBA Connect Scheme was jointly introduced by Guangdong, Hong Kong, and Macao authorities in November 2020 to address unmet clinical demand in Guangdong province. It allows innovative products that are already approved and marketed in Hong Kong or Macao to be used in China through approved medical institutions, provided a clear and documented urgent clinical need exists.

As a result, the pathway is particularly relevant for products addressing areas of high unmet need, including:

• Innovative oncology and immunology therapies
• Rare disease treatments
• High-value or specialized medical devices
• Advanced surgical instruments and implants

Products that hold CE marking or FDA approval, followed by registration in Hong Kong or Macao, are often well positioned for consideration under this framework.

While the scheme is rooted in addressing urgent patient needs, its broader importance lies in how it accelerates market entry, allowing overseas manufacturers to access clinical settings in Mainland China far earlier than would be possible through national registration alone.

Why the GBA Connect Scheme Matters to Overseas Manufacturers

The GBA Connect Pathway is not a replacement for national NMPA registration. Instead, it functions as a strategic entry point that enables earlier clinical access while long-term approval plans are underway.

The scheme currently covers more than 70 designated medical institutions across the Greater Bay Area, including leading tertiary hospitals that serve large and diverse patient populations.

Through participation, overseas manufacturers can:

• Establish an early clinical footprint in China
• Build relationships with key opinion leaders (KOLs) who influence national guidelines and procurement decisions
• Generate localized clinical experience and real-world data
• Validate pricing, logistics, and post-market processes in a controlled environment.

To fully realize these strategic advantages, manufacturers must also understand how responsibilities are structured within the GBA Connect framework and how submissions are operationally driven.

A Hospital-Driven Model: Roles and Responsibilities

Unlike national NMPA submissions, where manufacturers act as the applicant, the GBA Connect Pathway is hospital-driven.

Hospital Responsibilities

Designated medical institutions are required to:

• Identify and document a clear and defensible clinical gap
• Submit the formal application to Guangdong provincial authorities
• Oversee clinical use, safety monitoring, quality management, and in-hospital risk control

In practical terms, the hospital serves as the regulatory sponsor for the product’s use within its facilities.

Manufacturer Responsibilities

Although not the formal applicant, the overseas manufacturer remains central to the process. Manufacturers must provide comprehensive technical and regulatory support, including:

• Manufacturing and quality system certificates
• Clinical trial and post-market data from the home country
• Evidence of valid approval and marketing authorization in Hong Kong or Macao
• Evidence that the product has been procured by, supplied to, or is under active procurement consideration by public hospitals or other recognized healthcare institutions in Hong Kong or Macao, where applicable

This model requires close coordination, transparency, and regulatory alignment between the manufacturer and the hospital to meet Guangdong’s review standards. As a result, success under the GBA Connect Scheme depends less on formal applicant status and more on how effectively manufacturers support and enable hospital-led submissions.

How Overseas Manufacturers Can Navigate the GBA Connect Pathway

As hospitals coordinate with provincial authorities on applications, insurance coding, and clinical integration, manufacturers should take a structured and proactive approach.

Below is a five-step framework to maximize the likelihood of success:

Step 1: Identify and Confirm Urgent Clinical Need with a Hospital

Identifying the right hospital departments and engaging with key clinicians is the first step in the process. Manufacturers should:

• Target specific departments (e.g., oncology, cardiology) and consult with key clinicians such as therapeutic leads or department heads to discuss the clinical advantages of their product (e.g., efficacy, safety profile, usability, cost-effectiveness).
• Present clear comparative clinico-economic arguments (e.g., reduced length of stay, fewer complications, improved outcomes) to strengthen the case for product adoption.

Once urgent clinical need is clearly established, attention shifts from clinical justification to practical feasibility — particularly trial use and economic alignment.

Step 2: Arrange Trial Use and Align Pricing with Hospital Budgets

After confirming clinical need, manufacturers should work closely with the designated hospitals to arrange trial use and negotiate pricing:

• Be prepared to provide product samples for hospital trials under established protocols.
• Align pricing and procurement negotiations with the hospital’s budget cycles, ensuring that the product fits within reimbursement structures and payer coding.
• Strengthen the justification by securing reference sites and endorsements from clinicians, which will help in demonstrating both clinical and economic value.

With internal hospital support taking shape, manufacturers may consider whether early regulatory preparation can further reduce friction later in the process.

Step 3: Submit Optional Pre-Approval Filing with Guangdong Authorities

Manufacturers can streamline the submission process through an optional pre-approval filing with the Guangdong regulatory authority. This step offers the following benefits:

• Pre-store Product Data: By submitting product data and documentation in advance, manufacturers can reduce preparation time when the hospital later submits a formal application.
• No Guarantee of Approval: While a pre-approval filing helps expedite the process, it does not guarantee that the final hospital application will be approved. Conversely, skipping the pre-approval step does not preclude a successful submission.
• Tactical Use: Pre-approval filings can be used strategically to demonstrate readiness and help mitigate risks during early-stage hospital discussions. Manufacturers can work with local partners like Cisema to manage this filing process, with Cisema acting as the applicant.

At this stage, regulatory groundwork transitions into formal action, with the hospital assuming its role as applicant under the GBA Connect Scheme.

Step 4: Support Hospital-Led Submission under the GBA Connect Scheme

Once demand is confirmed, the designated hospital becomes the formal applicant and submits the product to the Guangdong authority. Manufacturers must support this step by providing:

• Comprehensive technical documentation, including quality evidence and post-market data.
• Clinical justification materials, such as studies, real-world data, and risk management documentation.
• Traceability and Risk Management: It’s crucial that manufacturers align their product data with China’s regulatory requirements, maintaining traceability and robust risk management procedures for the local market.

Approval marks a critical milestone, but not the end of the journey. Execution planning determines whether early access can be sustained and expanded.

Step 5: Plan Execution and Scale-Up for Broader Adoption

Successful adoption in one hospital can lead to broader opportunities. Manufacturers should:

• Plan for Scale: Ensure readiness to scale operations by aligning on supply chain logistics, including import agents, distribution channels, and cold-chain management (if required).
• Coding and Reimbursement: Coordinate with hospitals to streamline insurance coding and reimbursement.
• Post-Market Surveillance: Prepare to implement post-market surveillance procedures, a critical part of the long-term success of the product in China.
• Expansion Plans: Plan for multihospital expansion and consider the potential pathway to national registration for broader market access.

Beyond immediate commercial and clinical impact, GBA Connect participation creates a longer-term regulatory asset: real-world evidence generated in China.

Leveraging Real-World Data (RWD) for National Registration

One of the most strategic benefits of the GBA Connect Pathway is the ability to collect real-world data (RWD) from Chinese patients in routine clinical settings.

When properly designed and documented, this data can:

• Support future NMPA submissions
• Reduce the scope or complexity of required local clinical trials
• Strengthen overall regulatory and clinical credibility

Manufacturers are advised to design GBA clinical protocols with national registration objectives in mind, ensuring data quality, integrity, and traceability from the outset.

Practical Tips for Overseas Manufacturers Entering the GBA Market

To fully capture both near-term and long-term value, manufacturers should approach the GBA Connect Pathway with a disciplined set of best practices. Successfully navigating the GBA Connect Pathway requires clinical engagement, regulatory precision, and strategic patience.

Key best practices include:

• Anchor all submissions in strong clinical evidence from Hong Kong or Macao
• Develop a focused hospital engagement strategy early
• Ensure technical documentation is accurate, translated, and China-ready
• Implement post-market surveillance systems from the start
• Stay informed on updates to designated hospitals and eligible product categories
• Use the GBA as a testing ground for pricing and distribution strategies
• Work with experienced compliance and regulatory experts such as Cisema

When executed thoughtfully, these principles turn GBA Connect from a regulatory exception into a deliberate market-entry strategy.

Final Thoughts

The GBA Connect Pathway offers international manufacturers a practical and efficient route to bring innovative medical products to patients in China. By aligning closely with hospital needs, maintaining rigorous compliance standards, and planning beyond initial approval, companies can overcome traditional entry barriers and establish a strong regional presence.

More than a short-term opportunity, the scheme serves as a strategic foundation for national expansion. With the right preparation and expert local support, manufacturers can turn early access into long-term success.

For expert guidance on hospital coordination, regulatory filings, and execution strategy, Cisema provides comprehensive support across every stage of the GBA Connect process, helping companies move confidently into the Greater Bay Area and beyond. Contact us today to get started.

Further Information

• Explore our Medical Device Registration Services in Hong Kong
• Learn more about Cisema’s Drug Registration Services in Hong Kong

More from Cisema on the GBA Connect Scheme

• Guangdong MPA Publishes 2025 GBA Connect Scheme Medical Products Catalog (February 2026)
• Guangdong Releases 2026 Guideline for Importing Hong Kong and Macao Medical Devices into the Greater Bay Area (July 2026)
• Guangdong MPA Adds 27 Designated Hospitals to the GBA Connect Scheme (December 2025)
• GBA Connect Scheme: 25 New Designated Hospitals and 7th Batch of Approvals (October 2024)

Reference

Measure of using HK registered drugs and medical devices used in HK public hospitals in Guangdong-Hong Kong-Macao Greater Bay Area