中国食品药品监管Issue(6)：26-31,6.DOI:10.3969/j.issn.1673-5390.2025.06.004
口腔溃疡治疗类第二类医疗器械技术审评要点分析
Analysis of Technical Evaluation Points for Class Ⅱ Medical Devices for Oral Ulcer Treatment
摘要
Abstract
Oral ulcers are a common oral mucosal disease characterized by periodicity,recurrence,and self-limitation.Traditional treatment methods mainly include medication and nutritional supplementation.In recent years,the number of applications for Class Ⅱ medical devices based on physical therapy for oral ulcer treatment has gradually increased.To ensure the safety of medical devices for the public,this article systematically reviews the registration and application data of Class Ⅱ medical devices for oral ulcer treatment across various provinces from the perspective of provincial-level technical evaluation of medical device registration.It analyzes key considerations in the technical evaluation process,including management categories and attributes,technical requirements,biological evaluation,clinical evaluation,sample instructions for use,and labeling.The aim is to provide reference and guidance for both enterprises applying for the registration of Class Ⅱ medical devices for oral ulcer treatment and for provincial-level technical evaluators.关键词
医疗器械/口腔溃疡/注册申报/技术审评/用械安全Key words
medical device/oral ulcers/registration application/technical evaluation/device safety分类
医药卫生引用本文复制引用
牛丹,薛莉,张彩峰..口腔溃疡治疗类第二类医疗器械技术审评要点分析[J].中国食品药品监管,2025,(6):26-31,6.
