Study on the Disclosure System of the Evaluation and Approval Information of Medical Device Review in Japan.
10.3969/j.issn.1671-7104.2018.05.013
- Author:
Min CHEN
1
;
Gang DENG
1
;
Jingjing LIU
1
Author Information
1. Center for Medical Device Evaluation, CFDA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
disclosure principle;
evaluation report;
medical device
- From:
Chinese Journal of Medical Instrumentation
2018;42(5):357-360
- CountryChina
- Language:Chinese
-
Abstract:
In order to carry out the "opinions on deepening the reform of the evaluation and approval system and encouraging the innovation of drugs and medical devices" and push on governing by law, it is imperative to disclose the evaluation and approval information of medical device and protect citizens' right to know and right to supervision. In addition, while protecting the applicants' business secrets and technical secrets, the disclosure of technical evaluation reports will also help to break down technical barriers and promote the development of medical device industry in China that will be connecting with the world. Therefore, through the study on the disclosure system of the evaluation and approval information of medical device review in Japan, it provides references for disclosure of the evaluation and approval information of medical device in our country.
