Discussion on the Sterilization Material in the Registration Evaluation of Sterile Medical Device.
10.3969/j.issn.1671-7104.2019.05.014
- Author:
Hong QIAN
1
;
Yungao CHU
1
Author Information
1. Center for Certification & Evaluation, SHFDA, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
registration;
sterilization material;
technical evaluation
- MeSH:
Sterilization;
Surgical Instruments
- From:
Chinese Journal of Medical Instrumentation
2019;43(5):362-364
- CountryChina
- Language:Chinese
-
Abstract:
This article first introduces the regulation requirements for sterilization material in the registration evaluation of sterile medical devices. Secondly, the article chooses the suture passer set kit with multiple sterilization methods as an example product for technical evaluation. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluators how to make the evaluation for the medical device registration.
