The NMPA (CFDA) issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” (No. 77 of 2020) on US Thanksgiving Day, November 26th, 2020.
The first draft for feedback on “Technical Guideline on Real-World Data (RWD) Used in Medical Device Clinical Evaluation” was introduced by the NMPA last year, December 13, 2019.
Real-World Data used in clinical evaluation to support NMPA regulatory approval now offers additional pathways to the existing CER, overseas clinical trial data acceptance and clinical trial.
Coupled with Hainan “urgent” use policies to allow NMPA unapproved devices to be used in Hainan Lecheng in China, it will help overseas manufacturers to shorten their NMPA approval time and reduce the overall China market entry costs.
The guideline has the following sections:
- Common types of real-world data sources
- Real-world data’s quality evaluation
- Common types of real-world research designs and statistical analysis methods
- Common situations where real-world evidence can be considered for clinical evaluation of medical devices
- Common statistical analysis methods for real-world research on medical devices is listed in the appendix.
Eleven Common situations listed where real-world evidence can be considered for clinical evaluation of medical devices:
- Provide clinical evidence in CER pathway
- Provide overseas RWE for globally launched product
- Provide in-China RWE to support registration for clinical urgently needed product
- Provide external control for single arm study
- Provide evidence to build performance goal in single arm study
- Support the modification of the scope of application, indications, and contraindications
- Support clinical claim change in IFU
- Support conditional approvals post marketing data
- Support long-term safety and/or effectiveness evaluation of medical devices such as high-risk implants
- Support life-cycle clinical evaluation for rare disease product
- Support post marketing surveillance
We think that the real-world data coupled with Hainan “urgent” use policies offered alternatives to the traditional mandated China local clinical trials. Overseas manufacturers can obtain “urgent” use approval for their devices to be commercially sold in Hainan Lecheng without NMPA approval. Based on our experience, “urgent” use means the devices are innovative or better than the approved predicate devices in China. It does not mean “life-saving” devices. According to item 3 in the 11 commonly used situations in the guideline, real-world data generated from imported devices in” urgent” clinical use can be used to support product registration as a supplement to existing evidence.
For more details on Hainan program, please visit https://chinameddevice.com/medical-device-cro/real-world-data/hainan-real-world-data-study/ or contact us at Info@ChinaMedDevice.com for further understanding how these guidelines used together to accelerate your products commercial sales and regulatory approval.
With offices in Boston, Beijing and Hainan in US and China and seasoned bilingual and bicultural staff, China Med Device can provide you with the turnkey solution from interpreting the regulations to obtaining “urgent” use approval, RWD design and implementation, to product launches in China.