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NMPA Published Benefit-risk Assessment Guideline


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The NMPA released the “Medical Device Benefit-risk Assessment Guideline (2023 revised version)” on July 18, 2023. Through the benefit-risk judgment table in which standard review consideration factors are listed, the document aims to improve the predictability, consistency, and transparency of the pre-market review process.

The following aspects shall be given attention in the NMPA Benefit-risk Assessment:

Benefit factors

  • Different types of benefits, include enhancing patient self-care abilities, improving quality of life, facilitating functional recovery, increasing survival rates, preventing functional loss, and alleviating symptoms, etc.
  • Magnitude of benefits, usually utilizes clinical scoring scales to evaluate endpoint improvements or deteriorations.
  • Probability of benefits. Predict which patients are likely to benefit, including the size of patient group and the subgroup situations. If identifiable subgroups can be recognized, the device can be specified for use in those subgroup patients. Furthermore, when weighing benefits against risks, both the size and probability of benefits and risks should be simultaneously considered.
  • Duration of benefits. Treatments that require could I has higher risks or diminished benefits if the treatment requires long-time repetition.

Risk factors

  • Severity, type, quantity and frequency of adverse events related to device use:

Assess if it is serious adverse event, non- serious adverse event, or adverse event-unrelated implications. The implications include Anesthesia-related risks due to device implantation, the risks posed by the collection of human samples for IVD products.

  • Probability of adverse events. Consider the patient group and whether the adverse events happen one time and multiple times.
  • Duration of adverse events. Differentiate the temporary, minor harm; repeated but reversible harm; permanent, irreversible harm.
  • Risks introduced by false positive or false negative diagnostic results.

Other factors

  • Assessing the level of confidence in the advantages and disadvantages of the device, while taking into account variables like challenges in trial design, data accuracy, and potential for masking effects.
  • Patient-centered metrics, such as indicators of life quality and patient-stated results, contribute to treatment choices and act as substantiation for the advantages of the product.
  • Attributes of the illness, clinical impacts, and treatment background are imperative when evaluating the pros and cons.
  • The readiness of patients to embrace risks in relation to potential benefits, particularly in cases of enhancing life quality, impacts judgments about the balance between benefits and risks.
  • Appraise sanctioned alternatives for intended application, analyzing their effectiveness, hazards, and their alignment with patient and practitioner requisites.
  • Implement measures to diminish the likelihood of harm, including advisories, precautions, or scope limitations, and contemplate other strategies to manage risks.
  • The collection of real-world data can refine evaluations of benefits and risks, identifying new hazards, validating risk alleviation, and comprehending responses within specific patient subgroups.
  • Consider whether a device employs innovative technology to fulfill unmet medical requirements, even if the advantages are moderate or uncertain.

NMPA Benefit-risk Assessment Examples

The NMPA gives four examples with evaluation tables listed:

  • An implantable device intended for serious chronic conditions, with no other treatment exsited
  • A new memory replacement device intended for dementia and memory impairment. It is a permanently implantable device, and the patient must undergo a brain resection for the device to function properly. All the patient’s memories will be downloaded to the computer chip, and the device’s functions will be realized through the chip. Once a patient has the device implanted, any remaining memory they retain will be lost.
  • A new IVD product used in a serology test, dividing patients with BI-RADS 4 mammography results into two groups: a lower risk group which is recommended follow-up examination after several month; and higher risk group in which breast biopsy is recommended.
  • Product used for the functional evaluation of coronary artery disease in adult patients, which provides non-invasive evaluation for clinical routine use of coronary angiography images to determine whether coronary artery stenosis functions well.

For an English copy of the 103-page guideline, please contact us via email We charge nominal fees for the translation.

Watch our recorded webinar on Clinical Evaluation and Trial Key Changes to Support Order 739.

Innovation devices also require the benefit-risk assessment. See one of the latest examples for the Coronary Surgical Control System.

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