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RWS to be Applicable in GBA: New Regulation on Devices Urgent Use Policy Reveals

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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, Hong Kong or Macao approved drugs and medical devices can be utilized in GBA. They can be used only if the significant clinical benefits with urgent needs can be demonstrated.

Guangdong government issued 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. Feedback needs to be submitted by July 28, 2024.

A key change in the document is the availability of Real-World Study (RWS) in GBA. Previously, RWS can only be used in Hainan. Article 23 in the new regulations says that designated medical institutions in GBA are encouraged to collaborate with manufacturers to conduct real-world studies. The data from these studies can support for registration and marketing in mainland China.”

New Proposals

Highlights from the new regulations include:

  1. Designated Medical Institutions can be either mainland China or Hong Kong, Macao healthcare providers:
  2. Mainland China providers: general, specialized, or traditional Chinese medicine hospitals at or above the secondary level that have legally obtained the Medical Institution Practicing License and are in normal operation
  3. Hong Kong and Macao providers: Medical institutions through sole proprietorship, joint ventures, or cooperation
  4. Designated Medical Institutions must have the abilities as following:
  5. Possess specialized departments and expert technical capabilities that are suitable for the diagnosis and treatment projects involving urgently needed pharmaceuticals and medical devices from Hong Kong and Macao
  6. Have storage conditions that meet the characteristics and requirements of the instructions for urgently needed pharmaceuticals and medical devices from Hong Kong and Macao
  7. Have the conditions and capability for emergency handling of adverse reactions and events related to pharmaceuticals and medical devices
  8. Have established rules and regulations to ensure the safe use of urgently needed pharmaceuticals and medical devices from Hong Kong and Macao.
  9. For designated medical institutions that are listed in the government filling catalog, Guangdong MPA will issue review opinion within five working days from the date of receipt of the application. If the requirements are met, the approval document will be issued within five working days.
  10. For designated medical institutions that are not listed in the government filling catalog, Guangdong MPA will issue review opinion within ten working days from the date of receipt of the application. The time taken for expert review is not included in the time limits.
  11. Qualified medical professionals from Hong Kong and Macao are encouraged to practice in Guangdong for short-term periods.

Latest Urgent Devices

Ten devices have been added to the sixth batch of urgently needed devices, according to a notice published by Guangdong Health Commission on January 15, 2024:

  • Boston Scientific: FARAWAVE Pulsed Field Ablation Catheter
  • Boston Scientific: FARADRIVE Steerable Sheath
  • Boston Scientific: FARASTAR Pulsed Field Ablation Generator
  • Abbott: AveirTM Leadless Pacemaker
  • Abbott: AveirTM Delivery Catheter
  • Abbott: AveirTM Introducer
  • Abbott: AveirTM Retrieval Catheter
  • Medtronic: Heli-FX EndoAnchor System Heli-FX Applier with EndoAnchor Cassette
  • Medtronic: Heli-FX Ancillary EndoAnchor Cassette
  • Medtronic: Heli-FX EndoAnchor System Heli-FX Guide

Prior Guidance

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:

  1. Scope of urgent need for medicine and equipment
  2. Requirements for designated medical institutions
  3. Review and approval procedure
  4. Precondition of supplying
  5. Risk management
  6. 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. For the contract manufacturing policy in GBA, please click HERE

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