Reflections on the Key Points in the Establishment of the Guidelines for Class II Medical Device Technical Review-Example of Intraoral Digital Dental Impression / 中国医疗器械杂志

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 class II medical equipment technical guidelines written and 20-year experience in class II medical 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 class II medical equipment technical guidelines reference.

Analysis and Study in Testing of Infrared Therapy Equipment / 中国医疗器械杂志

This article summarizes the common problems in registration and supervision testing of infrared therapy equipment, combines YY 0306-2008 Particular requirements for the safety of heat radiation therapy equipment, GB 9706.1-2007 Medical electrical equipment-Part 1:General requirements for safety, Registration technical review guidelines for infrared treatment equipment, etc. This paper analyzes and discusses the following aspects, including classification and applicable standards, performance indicators and overtemperature protection. Some suggestions and solutions are given to provide some guidance for medical equipment manufacturers in design, research and development and registration, in order to avoid the problem effectively and improve the passing rate of testing.