Fourteen medical devices and three drugs are piloting in the Real-World Data Hainan program, according to RWD Initiation Meeting in Beijing on December 28, 2020. It’s the second group of medical products trialed for RWD.
The program, which has been piloted in Hainan since June 2019, was joined by eight overseas manufacturers, including one represented by China Med Device. Among them, Allergan’s Glaucoma treatment system (click here to see our comments) was approved in March 2020.
The implementation of Hainan’s fast track pilot program has effectively accelerated the registration time in China and reduced the cost, thus promoting the entry of international advanced drug and medical devices into the Chinese market. Meanwhile, this will provide more choices for domestic patients, and enabling more Chinese patients to benefit from international innovative drugs and medical devices.
The 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:
Eleven common situations are listed where real-world evidence can be considered for clinical evaluation of medical devices:
CMD can help you evaluate the feasibility of your product and please contact us for the list of the fourteen medical devices trialed in the RWD program.