A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of Self-examination Management Regulations for Medical Device Registration.
10.3969/j.issn.1671-7104.2023.03.019
- Author:
Ting HE
1
;
Shuang CHU
1
;
Jing XIE
1
Author Information
1. Shanghai Center for Medical Device and Cosmetics Evaluation and Verification, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
in vitro diagnostic reagent;
medical device registration;
self-examination
- MeSH:
Medical Device Legislation;
Reagent Kits, Diagnostic/standards*
- From:Chinese Journal of Medical Instrumentation
2023;47(3):324-327
- CountryChina
- Language:Chinese
-
Abstract:
On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.
