关键词: 医用钬激光设备, 注册申报, 适用范围, 量效关系, 动物试验, 监管要求

Abstract: Objective To summarize the standards and requirements for defining the intended use, dose-response relationships, and animal testing studies during the registration submission of holmium laser devices in order to provide guidance for applicants. Methods Related guidelines and requirements by the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) were analyzed in depth before the priorities of regulation were identified. Results A well-grounded framework was established for describing the intended use. The targets, methods and requirements for data analysis related to studies on dose-response relationships were elucidated. The types, objectives, and key considerations during animal testing were summarized. These outcomes could help enhance the quality of materials for submission and the efficiency of review. Conclusion Registration submissions for holmium laser devices have to be steered by clinical needs, backed up by data, and constrained by hierarchical, quantitative, and standardized requirements. Applicants should take into account the differences in required materials between the FDA and NMPA while focusing on core regulatory requirements to provide compelling evidence for product safety and effectiveness so as to be quickly approved for marketing.

Key words: Holmium Laser Device, Registration Submission, Scope of Application, Dose-Response Relationship Study, Animal Testing Research, Regulatory Requirements