Concept of Smart Regulation on Medical Devices under New Situation.
10.3969/j.issn.1671-7104.2019.01.011
- Author:
Jun HE
1
Author Information
1. Gansu Institute for Drug Control, Lanzhou, 730070.
- Publication Type:Journal Article
- Keywords:
credit management;
effective regulation;
healthy industrial development;
intelligent regulation;
medical devices;
professional regulation;
self-discipline;
smart regulation
- MeSH:
Humans;
Medical Device Legislation
- From:
Chinese Journal of Medical Instrumentation
2019;43(1):43-47
- CountryChina
- Language:Chinese
-
Abstract:
The traditional regulation mode on medical devices has invalid and negative effect problems. In order to more effectively ensure safety and efficacy of medical devices, promote healthy industrial development, this paper puts forward the innovative concept of smart regulation on the basis of problem orientation. Compared with traditional regulatory mode, smart regulation focus on effectiveness, and pays attention to relationship between effective regulation with self-discipline and industrial development, has characteristics of improving pertinence, effectiveness, accuracy, speed and efficiency of regulation. This paper further elaborates implementation approaches and attentions of smart regulation, by the ways of strengthening credit management, intelligent regulation, professional regulation, promoting self-discipline and encouraging innovation.
