Where the Real-World Data Come from? NMPA New Guideline Reveals

medical device CER
Clinical Evaluation Report (CER) for Medical Devices/IVD in China
February 22, 2020
Coronavirus Spurs Emergency Device Approvals in China; Reveals Lessons for Manufactures to Speed Market Entry (II)
February 27, 2020

Where the Real-World Data Come from? NMPA New Guideline Reveals

Real-world data (RWD) is data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings. Real-world data refers to observational data as opposed to data gathered in an experimental setting such as a randomized controlled trial (RCT).

What the Guideline Says

On December 13, 2019, NMPA issued the “Guideline on Real-World Data (RWD) Used in Medical Device Clinical Evaluation (Draft).” The document specifies the sources of RWD as following:

  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.

Significance of RWD in China

Real-World Data will become another clinical pathway for device approval in China, offering an alternative to currently available clinical pathways such as clinical evaluation report and overseas clinical data acceptance.

As RWD can be used prior to national NMPA approval, it can significantly shorten the time to begin selling devices in China. Hainan is the first province to pilot Real-World Data in China. Eight overseas manufacturers participated in the Hainan RWD program piloted since June 2019, including one represented by China Med Device, LLC.

The ability to start using devices in clinical settings prior to national NMPA approval is especially significant for manufacturers with high-priced devices, as RWD program participants can generate clinical data in the actual clinical environment with service fees, whereas traditional clinical trials need to be complimentary.

Certain protocols and guidelines need to be followed for the RWD to be admitted as part of the clinical evidence for submission.

To keep up to date on NMPA (CFDA) changes, please opt in our monthly newsletter https://ChinaMedDevice.com/cmd-blogs/

About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.