Concerns of Technical Evaluation on Registration of All-inside Meniscus Suture System.
10.3969/j.issn.1671-7104.2023.04.016
- Author:
Jintao GAO
1
;
Ruhan A
2
;
Jing WU
2
;
Bin LIU
1
Author Information
1. GBA Center for Medical Device Evaluation and Inspection, NMPA, Shenzhen, 518045.
2. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
all-inside meniscus suture;
meniscus repair;
sports medicine;
technical review
- MeSH:
Humans;
Menisci, Tibial/surgery*;
Suture Techniques;
Tibial Meniscus Injuries/surgery*;
Sutures;
Arthroscopy/methods*
- From:
Chinese Journal of Medical Instrumentation
2023;47(4):437-441
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To summarize the product registration declaration ideas and registration technical review of the all-inside meniscal suture system, and to systematically think about of the technical review concerns of the all-inside meniscal suture system products to provide technical guidance for improving the quality of registration and application and regulatory efficiency.
METHODS:Consult the public information of such products at home and abroad, and summarize the experience of registration review of such products.
RESULTS:The technical review of the all-inside meniscus suture system registration mainly focuses on product basic information, pre-clinical research, clinical evaluation and product technical requirements.
CONCLUSIONS:The difficulty of product registration and declaration of the all-inside meniscus suture system lies in the provision of pre-clinical research data of the product, and the applicant needs to strengthen the basic research ability, formulate scientific technical indicators and test methods to ensure the safety and effectiveness of the product, and also provide sufficient supporting data for the registration declaration.
