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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
Chinese Journal of Medical Instrumentation ; (6): 425-429, 2020.
Article in Chinese | WPRIM | ID: wpr-942754
ABSTRACT
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.
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Full text: Available Index: WPRIM (Western Pacific) Main subject: China / Computer-Aided Design / Technology Transfer / Imaging, Three-Dimensional Type of study: Practice guideline Country/Region as subject: Asia Language: Chinese Journal: Chinese Journal of Medical Instrumentation Year: 2020 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: China / Computer-Aided Design / Technology Transfer / Imaging, Three-Dimensional Type of study: Practice guideline Country/Region as subject: Asia Language: Chinese Journal: Chinese Journal of Medical Instrumentation Year: 2020 Type: Article