Discussion on key points for second type of medical sodium hyaluronate wound dressing
10.3760/cma.j.cn121382-20240422-00415
- VernacularTitle:第二类医用透明质酸钠创面敷料技术审评要点探讨
- Author:
Yongxia CHEN
1
;
Juntai ZHU
;
Ruiqi MAO
;
Wei SHI
;
Deshuang GOU
Author Information
1. 天津市医疗器械审评查验中心，天津 300191
- Keywords:
Sodium hyaluronate;
Wound dressings;
Technical review
- From:
International Journal of Biomedical Engineering
2024;47(4):411-414
- CountryChina
- Language:Chinese
-
Abstract:
With the development of the medical cosmetology industry, the market demand for medical sodium hyaluronate dressing is gradually increasing, but at present the product lacks the corresponding national standards. This problem makes this type of product face the problem of non-uniform standards in the quality control, registration declaration information content, technical review requirements, and other aspects. In this review paper, the classification of medical sodium hyaluronate wound dressing products was introduced, and the key points of the technical review were discussed, involving the division of the registration unit, raw material control, product performance indicators, and clinical evaluation. In addition, the key information review requirements in the process of registration and declaration of such products were analyzed, with a view to providing technical references for manufacturers and relevant regulatory agencies.
