Guangdong government published three documents on July 19, 2021 for feedback:
- Key Points for Application Materials for Import and Use of Hong Kong and Macau Medical Devices by Designated Institutions in the Greater Bay Area (Draft)
- Key Points for Application Materials for Import and Use of Hong Kong and Macau Drugs by Designated Institutions in the Greater Bay Area (Draft)
- Expert Database Management Measures for Greater Bay Area Clinical Urgent Need of Drugs and Medical Devices Imported from Hong Kong and Macau (Draft)
It is another major update after release of 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.
These policies have 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 Hongkong 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.
Application Materials for Institutions
Medical institutions in the area need to submit certification materials before importing and using Hong Kong and Macao medical devices. The materials include but not limited to the following:
- The qualification certificate of the unit. license documents of designated medical institutions, legal person certificates, business licenses, and medical institution practice licenses are required. Various certificates should be consistent with the application statement;
- The certification documents that have been purchased and used by public medical institutions in Hong Kong and Macau, as well as the approval documents approved by the original country of the manufacturer, and the approval documents of other countries;
- Samples of packaging, labels and manuals used in Hong Kong and Macau, as well as complete pictures of actual samples of products. Information about the product should be complete, such as: product structure, working principle, mechanism of action, main functions, intended use, etc. Passive medical devices also need to describe the main raw materials, and active medical devices also need to describe the functions of key components and software;
- Evaluation data on the safety and efficacy of the device from medical institutions. The medical device to be imported should be in urgent clinical need and have no other treatment methods, and the products currently on the market in China cannot achieve the same therapeutic effect;
- The medical institution’s explanation of the advanced nature of clinical application. The device should be advanced in terms of technical level or clinical application effects, such as basic principles, structural composition, manufacturing materials, production processes, performance indicators, clinical application effects, etc., superior to domestic approved medical devices.
The document also requires ethical review of medical devices, technical specifications, quality agreement materials for the entire lift-cycle management with detailed explanation. For an English copy of the “Key Points for Application Materials for Import and Use of Hong Kong and Macau Medical Devices by Designated Institutions in the Greater Bay Area (Draft)”, please email info@ChinaMedDevice.com.
The experts will be responsible for evaluation of the devices and drugs. They are recommended by pharmaceutical and device companies, medical institutions, and higher education institutions in Guangdong. They shall be selected from pharmacy experts, clinical experts, management experts, professors from higher education, experts from medical associations.