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Eight Urgent Needed Devices Designated in GBA: Medtronic, bioMerieux, Terumo on the List

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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 provincial NMPA will decide on import approval within 20 working days.

Eight devices as the third batch were enrolled to pioneer the clinical use in GBA on July 7, 2022, adding to the first two batches. Read more information on the second batch of GBA urgent devices announced in February 2022.

Complete List of Urgent Medical Device GBA

Eight devices have been added to the third batch of devices, designated as urgently needed, published by Guangdong Health Commission:

  • bioMerieux: FilmArray Torch (System Base/ Module/Empty Torch Bay Front cover FRU Kit)
  • bioMerieux: BioFire BCID2 Panel
  • bioMerieux: BioFire Respiratory Panel 2.1(RP2.1)
  • bioMerieux: FilmArray Pneumonia Panel Plus (Pneumoplus)
  • Medtronic: TYRXTM Absorbable Antibacterial Envelope
  • Dutch Ophthalmic Research Center: Posterior segment staining solution
  • Dutch Ophthalmic Research Center: Anterior segment staining solution
  • Terumo: Thoraflex Hybrid System

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)

Government 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.

Requirements for Application

The document specifies that the medical devices need to meet the below scenarios to be utilized in Guangdong:

  1. Urgently needed for clinical use.
  2. Already be used by public hospitals in Hong Kong and Macau.
  3. Have significant clinical advantage.
  4. Have not been approved in Mainland China.
  5. Have unmet medical needs.

The medical institutes need to meet the requirements as follows:

  1. They can be sole proprietorship, joint venture, or cooperation.
  2. Obtained medical institution’s practice license.
  3. Have robust management system in terms of supply, transportation, storage of medical products.
  4. 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.

See the contract manufacturing policy in the GBA.