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Fourteen Medical Devices Go into Hainan Real-World Data Pathway


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.

How to Obtain Real-World Data?

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:

  1. Data derived from electronic health records (EHRs)
  2. Medical claims and billing data
  3. Data from product and disease registries
  4. Patient-generated data, including from in-home-use settings
  5. Data gathered from other sources that can inform on health status, such as mobile devices.
  6. 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.

What Does the Real-World Data Do?

Eleven common situations are listed where real-world evidence can be considered for clinical evaluation of medical devices:

  1. Provide clinical evidence in CER pathway
  2. Provide overseas RWE for globally launched product
  3. Provide in-China RWE to support registration for clinical urgently needed product
  4. Provide external control for single arm study
  5. Provide evidence to build performance goal in single arm study
  6. Support the modification of the scope of application, indications, and contradictions
  7. Support clinical claim change in IFU
  8. Support conditional approvals post marketing data
  9. Support long-term safety and/or effectiveness evaluation of medical devices such as high-risk implants
  10. Support life-cycle clinical evaluation for rare disease product
  11. Support post marketing surveillance

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.

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