Research on Classification of Medical Devices with Nanomaterials.
10.12455/j.issn.1671-7104.240600
- Author:
Qian DONG
1
;
Li YI
1
;
Liyin WEN
1
;
Rui LIU
1
;
Jinglong TANG
1
;
Jiong ZHU
1
Author Information
1. National Institutes for Food and Drug Control（Center for Medical Device Standardization Administration）, NMPA, Beijing,
- Publication Type:Journal Article
- Keywords:
classification;
medical device;
nanomaterials
- MeSH:
Nanostructures/classification*;
Equipment and Supplies/classification*
- From:
Chinese Journal of Medical Instrumentation
2025;49(3):336-339
- CountryChina
- Language:Chinese
-
Abstract:
The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China's medical device regulation.
