More Information Released on the Pilot Trial in Greater Bay Area

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Before July 21, 2021 the devices and drugs from Hongkong and Macao public hospitals can be clinically used in a Shenzhen Hospital, according to a joint announcement by Guangdong NMPA and seven provincial agencies.

With the current policy in the Greater Bay area (our comprehensive review on the current policy), unapproved medical devices can be clinically used in the area,  as long as they are used in Hong Kong and Macao’s public hospitals and are granted an import certificate by Guangdong’s provincial government. The area constitutes Guangdong, Hong Kong, and Macao with over 70 million people. The notice also specifies the duties of government agencies:

  • The provincial NMPA will be responsible for selection of pilot drugs and medical devices and review and approval;
  • The provincial Health Commission is responsible for formulating the verification conditions and procedures for designated medical institutions, and formulating the review requirements and procedures for the clinical use of drugs and devices.
  • The Provincial Development and Reform Commission will strengthen the service coordination.
  • The Provincial Department of Finance is responsible for tax reduction.
  • The Guangdong Branch of the General Administration of Customs takes duty of import clearance.

As this Pilot program is progressing in Guangdong, more details with specific hospitals and implementing guidelines will be released.

Please contact us for more details about the new policy in the Greater Bay Area. Our email address is info@ChinaMedDevice.com.