Discussion on Technical Evaluation for Medical Device Registration Material
10.3969/j.issn.1671-7104.2017.04.014
- VernacularTitle:医疗器械注册资料技术审评探讨
- Author:
Yungao CHU
1
;
Hong QIAN
;
Yingfeng ZHU
Author Information
1. 上海市食品药品监督管理局认证审评中心
- Keywords:
research material;
technical evaluation
- From:
Chinese Journal of Medical Instrumentation
2017;41(4):286-288
- CountryChina
- Language:Chinese
-
Abstract:
This article first introduces the main contents of the requirements for medical device registration. Secondly, this article chooses the vertebral forming surgery system as an example to discuss the technical evaluation for the registration research material. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluator who make the evaluation for the medical device registration.
