Consideration for the Common Problems of the Preclinical Part in Medical Devices including Antimicrobial Agents Registration.
10.3969/j.issn.1671-7104.2018.02.016
- VernacularTitle:含抗菌剂医疗器械申报资料中临床前部分常见问题的思考
- Author:
Jiaxin TIAN
1
Author Information
1. Center for Medical Device Evaluation, CFDA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
antimicrobial agent;
combination product;
medical device
- MeSH:
Anti-Infective Agents;
Equipment and Supplies;
Registries
- From:
Chinese Journal of Medical Instrumentation
2018;42(2):137-139
- CountryChina
- Language:Chinese
-
Abstract:
This article summarizes and analyzes the common problems of the preclinical part in medical devices including antimicrobial agents registration. It is hoped to be helpful for researchers and manufacturers in the registration of medical devices including antimicrobial agents.