The Guangdong Provincial Medical Products Administration and the Guangdong Provincial Health Commission issued the “Administrative Measures for the GBA Urgently Needed Hong Kong–Macao Drugs and Medical Devices Catalog” on September 15, 2025, and the “Catalog of Urgently Needed Drugs and Medical Devices Imported from Hong Kong and Macao in the Nine Mainland Cities of the Greater Bay Area” on February 2, 2026. The following Q&A is based on these two documents.
Q1. What is GBA Urgent Use Policy?
The Greater Bay Area (GBA) medical device pathway is not a standard NMPA market authorization route. It allows certain Hong Kong– or Macao–approved medical devices to be temporarily used in designated hospitals in Guangdong Province without full NMPA registration or the national MPA approval. The Guangdong provincial MPA approves the devices that meet the criteria for the Greater Bay Area.
The GBA – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen, Zhuhai, Foshan, Dongguan, Zhongshan, Jiangmen, Huizhou, and Zhaoqing. These nine cities are applicable of urgent use policy for medical devices and drugs starting in May 2021. It is one of China’s most developed and affluent regions.
While not-yet-approved in the mainland, Hong Kong or Macao approved drugs and medical devices can be utilized in the GBA part of China. They can be used only if the significant clinical benefits with “urgent” needs can be demonstrated.
Q2. Who Applies for GBA Urgent Use?
Manufacturers input the product information to the pre-review database, and then hospital submits the application.
Previously, applications under the GBA urgent use pathway were initiated and managed only by designated Mainland GBA hospitals. However, according to the latest guidance, Administrative Measures for the GBA Urgently Needed Hong Kong–Macao Drugs and Medical Devices Catalog, issued on September 15, 2025, before the hospital submits the application, manufacturers or their local agents are now encouraged to submit product information directly to a pre-review database. This database serves as a repository of potential drugs and medical devices that may be considered for inclusion in the urgent use catalog.
Q3. What Devices Are Eligible for GBA Urgent Use?
To qualify for the GBA urgent use pathway, a medical device must simultaneously meet regulatory authorization requirements, urgent clinical need, and hospital capability criteria.
First, the device must already hold valid market authorization from either the Hong Kong Medical Device Division or the Macao medical device regulatory authority. Only products approved in these two jurisdictions are considered eligible for the GBA special access mechanism.
Second, the devices must be able to demonstrate a genuine and “urgent clinical need”. This includes showing that the device addresses a significant unmet medical demand and that no suitable alternative products are currently available in Mainland China.
“Urgent clinical need” does not necessarily refer only to life-threatening conditions. As of February 2, 2026, a total of 70 medical devices has been approved for use under the GBA policy. These products span multiple clinical areas, including general and plastic surgery, general hospital use, cardiovascular care, ENT, urology, and molecular diagnostics. Some of these devices are not intended for life-threatening conditions but have still been approved due to their clinical value in addressing unmet medical needs. Examples include the intragastric balloon system, disposable cooling system, cartilage regeneration collagen scaffold, and the Inspire® sleep remote control.
Finally, the hospital must demonstrate sufficient operational readiness to ensure safe clinical use. This typically includes:
- Availability of qualified and trained medical professionals
- Established clinical operation and training programs
- Comprehensive risk management and patient safety systems
The above combined eligibility requirements ensure that the GBA pathway remains clinically driven, patient-focused, and tightly controlled.
Q4. What Is the Application Submission Process?
The information required from manufacturers is relatively simple, typically including:
| Chinese Name | English Name | Scope of Application | Holder | Specification Model / Component | Packaging Specification | Remarks |
After that, the Guangdong Medical Products Administration assesses the hospital readiness and schedules expert review meeting. The meeting reviews:
- Technical information and product specifications
- Official proof of Hong Kong or Macao regulatory approval
- Clinical justification explaining medical necessity and urgency
- Risk control and safety management documentation
Based on above assessment, Guangdong Medical Products Administration makes a final determination on whether the product will be included in the catalog.
Q5. What Is the Approval Scope and What Are the Limitations?
Approval granted under the GBA urgent use mechanism is intentionally limited in scope and duration and does not constitute full market authorization in Mainland China.
Once approval is granted:
- The authorization is valid for one year and must be renewed annually if continued use is required.
- Cross-hospital use, general sales, nationwide distribution, and commercial promotion are not permitted.
As a result, the GBA urgent use pathway should be viewed as a controlled clinical access arrangement rather than a replacement for full NMPA product registration.
Q6. What Is the Strategic Purpose of the GBA Program?
The GBA urgent use program was created as part of China’s broader regulatory innovation strategy to accelerate access to advanced medical technologies while maintaining regulatory oversight and patient safety.
The key strategic objectives of the program include:
- Enabling faster patient access to innovative and high-end medical devices
- Promoting cross-border regulatory cooperation between Mainland China, Hong Kong, and Macao
- Supporting early clinical adoption and real-world data generation.
- Creating a transition pathway toward future full NMPA registration
For foreign manufacturers, the GBA mechanism can serve as a practical bridge between Hong Kong approval and broader Mainland China market entry. Its real word data can be used as supplement for the national approval by NMPA according to the “Regulations on the Management of Imported Drugs and Medical Devices from Hong Kong and Macao in the Nine Mainland Cities of the Greater Bay Area (Draft)” on July 4, 2024.
Q7. How Long Does It Take to Obtain GBA Approval?
Under the current regulatory framework, the official government review period for GBA urgent use applications typically ranges from ten to twenty working days. However, this statutory timeline does not reflect the full practical process. In real-world implementation, additional procedural stages significantly extend the overall timeline. From initial application submission to inclusion on the expert panel meeting agenda, it usually waits more than one month before the case is formally discussed by the expert review committee. After the expert meeting concludes, another one-month period is commonly required before the final approval outcome is officially published and released.
As a result, while the regulatory review itself may be completed within several weeks, the end-to-end timeline—from application submission to public announcement of approval—often spans two to three months or longer. The actual duration depends on factors such as completeness of clinical justification materials, hospital readiness assessment, scheduling of expert review meetings, and administrative processing efficiency.
We had a recent case in January, 2026 that took one and half month from submission to market approval in GBA.
Q8. How Many Devices have been Approved for GBA Urgent Use?
70 devices have been approved for GBA urgent use, according to Catalog of Clinically Urgently Needed Imported Drugs and Medical Devices from Hong Kong and Macau in the Nine Mainland Cities of the Guangdong-Hong Kong-Macau Greater Bay Area released on February 2, 2026.
China Med Device, LLC categorized the devices by FDA indications:
Cardiovascular
- TriClip steerable delivery system
- TriClip G4 delivery system
- Ultrasound-assisted thrombolysis catheter
- Ultrasound-assisted thrombolysis control system
- Diamondback 360 Coronary Orbital Atherectomy System with GlideAssist and controller
- Orbital atherectomy/rotational atherectomy system with infusion pump
- Viperwire Advance guidewire for coronary orbital atherectomy
- ViperSlide lubricant
- Freesolve Sirolimus-eluting bioresorbable magnesium coronary scaffold system
- Percutaneous ventricular assist device (pVAD) console
- High-flow left ventricular assist device (LVAD)
- Blood flow-directed mesh stent
- Transvenous tricuspid valve replacement system
- Left atrial appendage closure system
- Left atrial appendage closure measurement device
- Transcatheter aortic valve
- Delivery catheter system
- Compression loading system
Dental
- Injectable glycosaminoglycan-hyaluronic acid copolymer
Ear, Nose, and Throat (ENT)
- Cochlear implant
- Auditory brainstem implant
- Sound processor
- Upper eyelid ptosis correction system
Gastroenterology and Urology
- Intragastric balloon system
- PleurX pleural catheter mini kit
- PleurX drainage kit
- Gastrointestinal pathogen nucleic acid multiplex test kit
- Gastrointestinal functional endoluminal imaging system
- Gastrointestinal functional endoluminal imaging balloon catheter
- Single-channel endoscopic surgical instrument control system
General and Plastic Surgery
- Magnetically controllable lengthening titanium rod
- Scoliosis correction system (non-fusion vertebral tethering system)
- Upper eyelid ptosis correction system
- BioBrace soft tissue repair augmentation patch
- Cartilage regeneration collagen scaffold
- Absorbable collagen-based sealing hemostatic patch
General Hospital
- Disposable cooling system
- High-intensity focused ultrasound (HIFU) treatment system
Hematology
- Bloodstream infection multiplex pathogen nucleic acid test kit
- Blood flow-directed mesh stent
Immunology
- ALEX³ allergen test kit
- Multiplex array analyzer
Microbiology
- Upper respiratory tract pathogen nucleic acid test kit
- Pulmonary pathogen nucleic acid test kit
- Multiplex pathogen nucleic acid joint detection system
Neurology
- Inspire® implantable pulse generator
- Inspire® stimulation lead
- Inspire® sensing lead
- Inspire® sleep remote control
Obstetrical and Gynecological
- PRESERFLO™ MicroShunt glaucoma drainage device system
- Glaucoma drainage device
- TRUPULSE™ ablation system
Ophthalmic
- PRESERFLO™ MicroShunt glaucoma drainage device system
- Glaucoma drainage device
- Eye surgery Trypan Blue G blue-spectrum dye
Orthopedic
- Magnetic titanium lengthening rod
- BioBrace soft tissue repair augmentation patch
- Cartilage regeneration collagen scaffold
Radiology
- High-intensity focused ultrasound treatment system
Molecular Diagnostics
- Multiplex pathogen nucleic acid joint detection system
- Bloodstream infection multiplex pathogen nucleic acid test kit
- Upper respiratory tract pathogen nucleic acid test kit
- Pulmonary pathogen nucleic acid test kit
- Gastrointestinal pathogen nucleic acid multiplex test kit
- Magnetic breast tissue marker
- Magnetic tracer
- Magnetic detection and localization device