The Greater Bay Area (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.
While not yet approved in the mainland, drugs and medical devices approved in Hong Kong or Macao can be utilized as Greater Bay Area devices. They can be used only if the significant clinical benefits with urgent needs can be demonstrated. Guangdong provincial NMPA will decide on import approval within 20 working days.
Five devices were enrolled to pioneer the clinical use in the GBA. The policy has already incubated the clinical use of magnetically controllable extension titanium rod and anti-D immunoglobulin injection in Hong Kong University Affiliated Shenzhen Hospital.
Both products were approved in Hong Kong and Macau and used in public hospitals there. Anti-D immunoglobulin injection is indicated to prevent neonatal hemolysis caused by RhD-negative women when they become pregnant again. Magnetically controllable growing titanium rod is indicated to correct severe spinal deformities for children.
Four devices have been added to the two batches of devices, designated as urgently needed, published by Guangdong Health Commission:
- Magnetic controllable extended titanium rod
- Manual Extender
- Drawbar Electromagnetic Retractor
- Punctuation – Endoscopy Stain Marker Ink
- Cell sorting/processing systems
Five hospitals are on the list. Not only tier-3 but also tier-2 hospitals are included:
- Shenzhen: The University of Hong Kong Affiliated Shenzhen Hospital (Tier 3)
- Zhongshan: Zhongshan Chen Xinghai Hospital (Tier 3)
- Guangzhou: Guangzhou Modern Hospital (Tier 2), Guangzhou United Family Hospital (Tier 2)
- Zhuhai: Zhuhai Simalin Shunchao Eye Hospital (Tier 2)
The Guangdong government released the “Interim Provisions on the Administration of Imported Medicines and Medical Devices in Urgent Clinical Needs in the Guangdong-Hong Kong-Macao Greater Bay Area” on August 27, 2021, finalizing a series of first-of-its-kind measures in China for NMPA unapproved devices.
The provisions include 29 articles, providing clear guidebook for the aspects below:
- Scope of urgent need for medicine and equipment
- Requirements for designated medical institutions
- Review and approval procedure
- Precondition of supplying
- Risk management
- Recall process
Requirements for Application
The document specifies that the medical devices need to meet the below scenarios to be utilized in Guangdong:
- Urgently needed for clinical use.
- Already be used by public hospitals in Hong Kong and Macau.
- Have significant clinical advantage.
- Have not been approved in Mainland China.
- Have unmet medical needs.
The medical institutes need to meet the requirements as follows:
- They can be sole proprietorship, joint venture, or cooperation.
- Obtained medical institution’s practice license.
- Have robust management system in terms of supply, transportation, storage of medical products.
- Have adverse reaction monitoring agency and emergency plans.