Analysis of Key Points and Difficulties in Registration Application of Inflatable Bone Expander.
10.3969/j.issn.1671-7104.2021.04.016
- Author:
Ruhan A
1
;
Jiazhen ZHANG
1
;
Bao ZHAI
1
;
Bin LIU
1
Author Information
1. Center for Medical Device Evaluation of NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
PKP;
inflatable bone expander for the treatment of osteoporotic vertebral;
key process verification;
medical device registration;
osteoporotic vertebral compression fracture;
product performance research
- MeSH:
Bone Cements;
Fractures, Compression;
Humans;
Spinal Fractures;
Treatment Outcome
- From:
Chinese Journal of Medical Instrumentation
2021;45(4):424-428
- CountryChina
- Language:Chinese
-
Abstract:
With the advantages of inflatable bone expander in the treatment of osteoporotic vertebral compression fractures, the number of applications for registration of such products is increasing. Based on the characteristics of the medical device, this article analyzed and summarized the relevant requirements for the basic information, product performance research, product manufacturing, clinical evaluation, and product instructions that should be focused on the registration application dossiers, as well as comply with the requirements of CMDE. The focus of the registration application for Inflatable Bone Expander should be the standardization of the application dossiers, while the difficulty was the scientific rationality of the research data. Comments and suggestions are provided to relevant practitioners on standardization of registration application dossiers. It may help them to optimize the quality of registration application dossiers while improve the efficiency of registration applications.
