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, 2020Where 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:
- 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.
It also describes eleven situations where RWD can be used in China:
- To be used in Clinical Evidence Report (CER) for comparison of same type products;
- To be used with existing clinical evidence to support product registration;
- To be used as supplementary data to support product registration;
- To be used as the external control for single group experiment;
- To provide clinical data for the establishment of single-arm objective performance criteria;
- To support modification of Scope of Application and Intended Use;
- To support modification of clinical claims in package insert;
- To support postmarket studies on products which are granted Conditional Approval;
- To be used for the evaluation of long-term safety and efficacy of high-risk implants or similar medical devices;
- To be used for clinical evaluation of a medical device for treatments of rare disease throughout the full Life Cycle to expedite the product registration;
- To be used for postmarket surveillance.
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.
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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.