NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging System with Same Variety” on February 1, 2021. The 16-page document provides manufacturers detailed pathway for clinical evaluation, which is less time-consuming and more cost-effective than clinical trial.
The guideline refers to FDA guidance of “Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices”.
This guideline applies to general MR systems and MR components of multi-modal systems such as PET/MR systems. Intraoperative MR systems and those for specific locations (e.g. breast or extremities) and populations ae also applicable. This guideline does not apply to MR systems with magnetic field strength greater than 3.0T, software parts with auxiliary decision-making functions, quantitative imaging and magnetic resonance spectroscopy imaging technologies.
Demonstration of Safety and Efficacy
The applicants shall conduct the clinical evaluation with the method of same variety comparison, based on the Guideline Basic Principles of Clinical Evaluation of Medical Devices. 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.
If the difference of key hardware or software (magnet, spectrometer, radio frequency system, gradient system, receiving coil, pulse sequence, etc.) affects the image quality, the applicant needs to carry out the corresponding phantom test to compare the differences in imaging performance of products.
The performance of the phantom image has to be no inferior than that of the predicate product, otherwise the applicant needs to provide a body image sample for confirmation, or provide equivalent research clinical literature and related data.
The guideline also describes the principles of phantom test and body imaging samples.
In the Annexes section, NMPA provides form for comparison items and template of phantom test and body imaging samples confirmation.
For an English copy of the guideline, please email info@ChinaMedDevice.com.