Analysis of Revision Content and Evaluation Attentions on Guidance for Registration of Metallic Bone Plate Internal Fixation System (Revised in 2021).
10.3969/j.issn.1671-7104.2023.03.016
- Author:
Jing WU
1
;
Le JIN
1
;
Lihua DONG
1
;
Dan HAN
2
;
Xinli SHI
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
2. GBA Center for Medical Device Evaluation and Inspection, NMPA, Shenzhen, 518045.
- Publication Type:Journal Article
- Keywords:
dividing registration unit;
medical device registration;
metallic bone plate internal fixation;
physical and mechanical performance;
standard specification
- MeSH:
Bone Plates;
Fracture Fixation, Internal;
Biomechanical Phenomena
- From:Chinese Journal of Medical Instrumentation
2023;47(3):312-316
- CountryChina
- Language:Chinese
-
Abstract:
This study briefly introduces the revised content of Guidance for Registration of Metallic Bone Plate Internal Fixation System (Revised in 2021) compared to the original guidance, mainly including the principles of dividing registration unit, main performance indicators of standard specification, physical and mechanical performance research, and clinical evaluation. At the same time, in order to provide some references for the registration of metallic bone plate internal fixation system, this study analyzes the main concerns in the review process of these products based on the accumulation of experience combining with the current review requirements.
