Reflections on the Key Points in the Establishment of the Guidelines for Class II Medical Device Technical Review-Example of Intraoral Digital Dental Impression.
10.3969/j.issn.1671-7104.2020.05.010
- Author:
Hong QIAN
1
Author Information
1. Center for Certification and Evaluation, Shanghai Food and Drug Administration, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
product research;
technical evaluation;
technical review guidelines
- MeSH:
China;
Computer-Aided Design;
Imaging, Three-Dimensional;
Technology Transfer
- From:
Chinese Journal of Medical Instrumentation
2020;44(5):425-429
- CountryChina
- Language:Chinese
-
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.
