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”
Non-clinical Data and Image Samples Suffice
“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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Highlights in the Guideline
China Med Device summarizes following key points for the guideline:
- The static magnetic field generation method (permanent magnetic type, normal conductive type, superconducting type) and resonance nuclei shall be the same as the predicate device
- Key component indicators such as the static magnetic field strength shall have no significant differences to the predicate device
- Module test is required if differences in key components (magnets, spectrometers, RF systems, gradient systems, receiving coils, scanning protocols, pulse sequences, etc.) affect image quality
- The clinical requirements are met if the module image performance indicators are not inferior to the predicate
- Human imaging samples, literature review or clinical data are needed, if the clinical requirements are not met.
Module Test Requirements
The guideline lists the following requirements for module test:
- The module test shall refer to “YY/T 0482 Determination of the Main Image Quality Parameters of Medical Imaging Magnetic Resonance Equipment”
- The image performance indicators include signal-to-noise ratio, uniformity, two-dimensional layer thickness, two-dimensional geometric distortion, and spatial resolution
- The test conditions must be consistent with those of predicates. Typical scanning sequence shall be chosen for the 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.