Study on Regulations of Exemption in Medical Device Registration and Approval Process in the United States and China.
10.3969/j.issn.1671-7104.2019.02.013
- Author:
Kai HU
1
;
Hui YANG
1
Author Information
1. Zhejiang Medical Device Evaluation Center, Hangzhou, 311121.
- Publication Type:Journal Article
- Keywords:
exemptions;
legal research;
medical devices;
registration
- MeSH:
China;
Device Approval;
Humans;
Registries;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2019;43(2):122-125
- CountryChina
- Language:Chinese
-
Abstract:
Registration and approval is a necessary step in product marketing process of new medical devices to ensure their safety and efficiency.At present,many countries are relatively strict in the management of high risk medical devices,especially for class Ⅲ medical devices.Taking clinical trials as examples,they cost too many human,material resources.FDA has introduced a variety of regulations and policies to streamline the registration process to speed up the product marketing process.Based on the introduction of the relevant regulations on the exemption in parts of medical device registration and approval process in the United States,this paper compares and analyzes the simplified status of medical device approval in China.In the end,the significance of exemption in the registration and approval process is expounded,and some suggestions on how to optimize and approve the registration and approval process of medical devices in China are put forward.
