NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging (MRI) System Comparing the Similar Device (draft)” on August 13, 2020. The 19-page document provides manufacturers detailed pathway for clinical evaluation, which is less time-consuming and cost-effective than clinical trial.
The guideline refers to FDA Guidance Document “Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices”
“Based on “Technical Guidelines for Clinical Evaluation of Medical Devices”, the applicants shall determine the applicable clinical evaluation path, and provide the corresponding clinical evaluation data”, NMPA states in the Guideline Basic Principles.
The applicants shall conduct the clinical evaluation with the method of same variety comparison. The differences to the predicate equipment shall be provided to demonstrate that the safety and effectiveness of the declared product are not impacted by the differences.
The guideline also says the non-clinical data, such as laboratory data (e.g. module test) and, if necessary, human image samples shall be provided to confirm the effect of differentiation on image quality to the predicates.
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China Med Device summarizes following key points for the guideline:
The guideline lists the following requirements for module test:
The guideline also provides the comparison items, clinical evaluation pathways chart, module test report template, and specifies the human image sample requirements. For an English copy of the guideline, please email info@ChinaMedDevice.com.