第二类医疗器械产品技术审评指导原则中关键点确立的思考——以口腔数字扫描仪为例

Reflections on the Key Points in the Establishment of the Guidelines for Class Ⅱ Medical Device Technical Review—Example of Intraoral Digital Dental Impression

医疗器械技术审评指导原则是规范和统一全国医疗器械产品注册技术审评的工作标准。如何提高医疗器械技术审评指导原则撰写质量,既关系到技术审评速度,也涉及到批准上市产品的安全有效。该研究基于近30项第二类医疗器械技术审评指导原则的撰写和20年第二类医疗器械产品注册技术审评实践,以口腔数字印模仪为例,对指导原则中产品综述资料和研究资料中几个关键点提出思考,供从事第二类医疗器械产品注册技术审查指导原则撰写工作的研究者讨论。

Technical Review Guidelines of Medical Devices are standards to standardize and unify registration review of medical devices marketed in China.The writing quality of the guidelines affects not only the time for technical evaluation,but also the safety and effectiveness of approved products.Based on authors’practices of nearly 30 classⅡmedical equipment technical guidelines written and 20-year experience in classⅡmedical device evaluation,this study takes intraoral digital dental impressions as an example to put forward several key points of sections"summary"and"research data"in the guidelines,for researchers on classⅡmedical equipment technical guidelines reference.