In order to further standardize the management of medical X-ray diagnostic equipment (Class III), the Center for Device Evaluation of the State Food and Drug Administration organized the formulation and release of the “Guidelines for Clinical Evaluation and Registration Review of the Same Type of Medical X-ray Diagnostic Equipment (Class III)”.
Scope of application
This guideline is applicable to medical angiographic X-ray machines, mobile C-arm X-ray machines, fluoroscopy X-ray machines, oral and maxillofacial cone-beam computed tomography equipment, and limb cone-beam computer Tomography equipment. According to the current “Medical Device Classification Catalog” [1], the above product classification codes all belong to 06-01.
Among them, mobile C-arm X-ray machines and fluoroscopic X-ray machines have been included in the “Catalogue of Medical Devices Exempted from Clinical Evaluation (2021)” [2] (referred to as “Catalogue”). This guideline applies to the “Catalogue” “Except for the clinical evaluation of mobile C-arm X-ray machines with digital tomography functions and fluoroscopy X-ray machines of the same variety, mobile O-shaped/G-arm X-ray machines with digital tomography functions are also Clinical evaluation can be carried out with reference to the applicable requirements of this guideline.
The content of oral and maxillofacial cone beam computed tomography equipment involved in this guideline is the published “Oral and maxillofacial cone beam computed tomography equipment registration technical review guidelines” [3] “Oral and maxillofacial cone beam computer Revision of the relevant content of the Guiding Principles for Technical Review of Clinical Evaluation of Tomography Equipment [4].
Registration applicants need to comprehensively evaluate the hardware and software functions of the product. Considering the diversity of products and functions, this guideline only proposes and standardizes the clinical evaluation requirements for the medical image quality of products.
If the product to be declared has brand-new technical characteristics for a key device (including software) compared with products already on the market in China, or the product to be declared has a new scope of clinical application, if it cannot be proved by non-clinical research data, human image sample data, etc. The data prove the safety and effectiveness of the declared product, and the registration applicant needs to consider obtaining clinical data through clinical trials.