“Selection of Urgent Needed Drugs and Medical Devices for Insurance Application” was published by Hainan Boao Tourism Pilot Zone Administration on February 10, 2022. It asks foreign manufacturers to submit the application to get their medical products enrolled in the insurance poll. The deadline is March 31, 2022.
Requirements for Selection
Device must meet the following two scenarios:
- Foreign approved
- No same-variety-device approved in China
- The device will be available in six months after it passes the selection
- Product supply is stable and prompt
- Technical support and local doctors’ training are available
For the processes of selection and certification listed in the document, please email info@ChinaMedDevice.com.
Latest Development in Hainan Policy
The NMPA held a conference in Beijing on December 27, 2021, to discuss the Real-World Data program and better enhance the approval system for urgent needed imported devices.
Allergan’s Glaucoma treatment system became the first medical device obtained NMPA Approval through Real-World Data (RWD) program. The program, which has been piloted in Hainan since June 2019, was joined by eight overseas manufacturers, including some represented by China Med Device.
In the past, imported medical devices spend at least 3 to 5 years to enter the China market. However, from RWD status to final approval, it only took five months for Allergan to list the glaucoma system on the market. View Allergan’s Approval Timeline.
Second Batch of Real-World Data Imported Device
45 imported devices were included in the second batch of real-world data program in Lecheng Pioneer District, Hainan, starting from October 2020, compared to 11 devices in the first batch. These products come from 30 large multinational companies, including the following:
- Boston Scientific
- Roche Diagnostics
- Advanced Bionics
- Santen Pharmaceuticals
- … …
At the same time, many imported medical device products have begun to apply for clinical examination and approval of imported medical devices to be able to borrow the “dongfeng” of real-world data approval. As of December 23, the state has approved 3,930 sets of 75 batches of 103 types of medical devices urgently needed to be imported for clinical use in 1,142 patients.
How to Obtain RWD?
Hainan Boao is the first area in China where RWD can be widely used. NMPA issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” on November 26, 2020. It specifies six ways to acquire RWD:
- Data derived from electronic health records (EHRs)
- Medical claims and billing data
- Data from product and disease registries
- Patient-generated data, including from in-home-use settings
- Data gathered from other sources that can inform on health status, such as mobile devices.
- Data generated from the complete life cycle of the medical device: production, sales, transportation, storage, installation, use, maintenance, decommissioning, and disposal. The data includes acceptance reports, maintenance reports, user feedback, use environment, calibration records, operation log, image raw data, etc.