On July 18, 2023, China NMPA released the "Medical Device Benefit-risk Assessment Guideline (2023 revised version)." This guideline is designed to enhance the predictability, consistency, and transparency of the pre-market review process for medical devices. It achieves this by introducing a structured benefit-risk judgment table that lists standard factors for consideration. Here, we summarize some of the key elements and principles outlined in the NMPA Benefit-risk Assessment.
Benefit Factors:
Types of Benefits: Consider how the device enhances patient self-care abilities, improves quality of life, aids functional recovery, increases survival rates, prevents functional loss, or alleviates symptoms.
Magnitude of Benefits: Evaluate endpoint improvements or deteriorations using clinical scoring scales.
Probability of Benefits: Predict which patients are likely to benefit, including the size and characteristics of patient groups. Identifying subgroups can lead to specifying the device for use in those subgroups. When assessing benefits against risks, consider both the size and likelihood of benefits and risks simultaneously.
Duration of Benefits: Recognize that treatments may carry higher risks or reduced benefits if they require long-term repetition.
Risk Factors:
Severity, Type, Quantity, and Frequency of Adverse Events: Assess whether adverse events related to device use are serious or non-serious and consider implications such as anesthesia-related risks and risks associated with sample collection for in-vitro diagnostic (IVD) products.
Probability of Adverse Events: Examine the patient group and the occurrence of adverse events, including whether they occur once or repeatedly.
Duration of Adverse Events: Differentiate between temporary, minor harm; repeated but reversible harm; and permanent, irreversible harm.
Risks from False Diagnostic Results: Account for the risks introduced by false positive or false negative diagnostic results.
There are other factors such as:
- Assess confidence in pros and cons, factoring in trial challenges and data accuracy.
- Implement risk mitigation measures and explore other risk management approaches.
- Collect real-world data to enhance evaluations and understand patient subgroups.
- Consider innovative technology for unmet medical needs, even with moderate advantages.
The guideline provides concrete examples of NMPA benefit-risk assessments, including cases involving high-risk implants and diagnostics. These examples illustrate the importance of providing concise and high-level summaries at the beginning and end of submissions to align with the reviewer's expectations. Manufacturers can use these examples to understand how to structure their submissions effectively.
If you want to learn more details and see how it is relevant to FDA and EU type of risk and benefits guidelines, please feel free to email me at gpalma@ChinaMedDevice.com
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Grace Fu
China Med Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------