NMPA published the Technical Guidelines on Medical Device Clinical Evaluation (draft) on January 2, 2020 for feedback. The draft Guidelines consist of three documents:
- Clinical Evidence – Key Definitions and Concepts
- Clinical Evaluation
- Clinical Trial
In the Clinical Evaluation section, the Guidelines answer how data generated through literature searching, clinical experience and clinical investigation may be used in clinical evaluation
, and how to analyze and document a clinical evaluation.
For clinical experience, NMPA recognizes a wide range of Real-World Data (RWD), including:
- Post market surveillance reports, registries or medical records (which may contain unpublished long-term safety, clinical performance and/or effectiveness data);
- Adverse events databases (held by either the manufacturer or regulatory authorities); and
- Details of clinically relevant field corrective actions (e.g. recalls, notifications, hazard alerts).
NMPA explains that “clinical experience is a useful source of clinical data for low risk devices that are based on long standing, well-characterized technology and, therefore, unlikely to be the subject of either reporting in the scientific literature or clinical investigation.”
NMPA keeps in line with international standards. “The clinical evaluation registries that fit the IMDRF (International Medical Device Regulators Forum) definition and qualifiers have potential to be used for regulatory decision making” the guidelines say.
Full Life Cycle Evaluation
NMPA will pay more attention on full life cycle clinical evaluation:
- During the design and development stage, the clinical evaluation should determine the clinical data required for the pre-market product evaluation, determine whether a clinical trial is needed and the clinical outcome that needs to be observed.
- After the product is launched to the market, periodic clinical evaluations are required as product safety, clinical performance, and effectiveness information is continuously updated.
- The above updated information will be entered into the risk management process and may cause changes in risk assessments, clinical trial documents, instruction for use (IFU), and post-market activities.
The clinical trial section classifies the needs regarding if the human clinical trial is necessary and mentions the principles in clinical design and its ethical considerations.
Although clinical trials are usually needed for high-risk and novel medical devices, it may not be necessary for established technology. “The available clinical data in the form of published literature, reports of clinical experience, post-market reports and adverse event data may be adequate to establish the safety, clinical performance and effectiveness of the medical device, provided that new risks have not been identified, and that the intended uses have not changed”, NMPA states.
The documents are harmonized with the clinical requirements of the IMDRF. IMDRF Committee Members passed the NMPA’s proposal of “Medical Device Clinical Evaluation”. The proposal was published on June 5, 2019 for feedback and the final English documents are now available on the IMDRF website. http://www.imdrf.org/consultations/cons-clinical-evaluation.asp.
For English version of the three documents, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
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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 agent 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.