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. Now, these nine cities are applicable of urgent use policy for medical devices and drugs. Five hospitals will be the first batch to pioneer the clinical use of medical products approved and used in Hong Kong and Macau.
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 starting in May 2021. 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.
First Batch Hospitals
Not only tier-3 but also tier-2 hospitals are included in the first batch published by Guangdong Health Commission:
- 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 draft was issued in July 2021.
Hong Kong or Macao approved, but not-yet-approved in the mainland, drugs and medical devices can be utilized in nine cities in Guangdong province. They can be used only if the significant clinical benefits with urgent needs can be demonstrated. It was dated back to November 25, 2020 when central government first formalized the medical urgent needs policy in Great Bay Area. Now, the Guangdong government further guides overseas manufacturers, medical institutes, and delegated suppliers on how to purchase, import, and supply the medical products.
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
If your devices are used in Hong Kong and Macau, and you want to clinically use them in Guangdong, please contact info@ChinaMedDevice.com.
Requirements for Application
The document specifies that the medical devices have 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 have 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.
Along with the Interim Provisions are the Submission Materials and Review Guideline. Please email us at info@ChinaMedDevice.com to get an English copy.