Recently, the State Food and Drug Administration issued four technical guiding principles based on the “Medical Device Registration and Filing Management Measures” to further strengthen the supervision and guidance of medical device product registration and improve the quality of registration review.
The “Guiding Principles for Technical Review of Clinical Evaluation of Same Types of Ultrasonic Soft Tissue Cutting and Hemostasis Systems” clearly states that registration applicants need to determine the clinical evaluation path based on the actual situation of the applied product and provide corresponding clinical evaluation data. Regarding the differences between the product to be applied for and medical devices of the same type, registration applicants need to submit sufficient scientific evidence to prove that the two have the same safety and effectiveness, such as in vitro burst pressure tests and animal tests. The “Guiding Principles for Registration and Review of Clinical Evaluation of Same Types of Oral Implant Surgery Navigation and Positioning Systems” applies to the same type of clinical evaluation of non-autonomous oral implant surgery navigation and positioning systems. The above two guiding principles respectively introduce the basic requirements for clinical evaluation of the same type of medical devices from five aspects: comparison of device selection, comparison of applicable scope and clinical use-related information, comparison of technical characteristics, evidence of safety and effectiveness of different parts, and clinical data of medical devices of the same type.
Microwave ablation equipment in the “Microwave Ablation Equipment Registration Review Guidelines” refers to microwave hosts and accessories that perform ablation treatment on diseased tissue in the body through percutaneous puncture of electromagnetic waves with a transmission frequency greater than 300 MHz but not exceeding 30 GHz under the guidance of imaging and other auxiliary equipment. For microwave treatment equipment that contains both ablation and superficial tissue thermal coagulation functions, this guideline applies to the ablation portion using microwave ablation needles.
The “Guiding Principles for Registration Review of Power Equipment in Endoscopic Surgery” applies to power devices driven by a power source. The power device provides the required mechanical power for tool heads (such as planing heads, grinding heads, drill bits, etc.) to mince or remove tissue during endoscopic surgery.
