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Within 20 Days, Guangdong NMPA Will Decide if Your Unapproved Device Can GO into the Greater Bay Area

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The Guangdong government published 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 (draft)” on June 21, 2021, proposing a series of first-of-its-kind measures in China for NMPA unapproved devices. Feedback needs to be submitted by July 5, 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 announcement synchronizes with the development of Guangdong-Hong Kong-Macau Greater Bay Area, which houses over 70 million people. 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:

  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 have to meet the requirements as follows:

  1. Health providers from Hong Kong and Macao that have medical services in nine cities in Guangdong are applicable.
  2. They can be sole proprietorship, joint venture, or cooperation.
  3. Obtained medical institution’s practice license.
  4. Have robust management system in terms of supply, transportation, storage of medical products.
  5. Have adverse reaction monitoring agency and emergency plans.

Along with the Interim Provisions is the Submission Materials and Review Guideline. Please email us at info@ChinaMedDevice.com to get an English copy.

Real World Data & Other Highlights

Real World Data (RWD) accumulated in Guangdong can be used to support the national NMPA registration, the document says. It is the second area in China where RWD can be widely used.

For the latest news on Hainan’s RWD program, pleas click HERE. For our webinar on Hainan RWD program, please click HERE.

Other highlights from the document include:

  1. The Guangdong provincial NMPA shall decide on import approval within 20 working days. The approval document shall be valid for one year; the reason will be given if not approved.
  2. The price of the new service items will be determined by the medical institution for a trial period of two years.
  3. New consumables will be promptly included into the provincial insurance payment.
  4. Medical institutions commission medical device companies to purchase, import and distribute medical devices.
  5. The medical institutions shall apply for the medical device import declaration and the Guangdong Customs shall verify and release in time.
  6. Ethnic committee review and informed consent are needed before the use of medical products.
  7. Certification documents, transaction notes and purchase records shall be kept for 2 years after the medical device’s validity period; those of implantable medical device shall be kept permanently.