【CODEX】Guideline for Stability Study of Passive Implantable Medical Devices (Revised in 2022)
无源植入性医疗器械稳定性研究指导原则（2022年修订版）-双语版
Guideline for Stability Study of Passive Implantable Medical Devices
(Revised in 2022)
本指导原则旨在指导注册申请人进行无源植入性医疗器械稳定性研究及注册申报资料的准备及撰写，同时也为技术审评部门提供参考。
This Guideline aims at guiding registration applicants to prepare and write registration application dossiers for stability study of passive implantable medical devices and also provide reference for CMDE (Center for Medical Device Evaluation) to review.
本指导原则是对无源植入性医疗器械稳定性研究的一般要求，申请人应依据产品的具体特性确定其中内容是否适用。若不适用，需具体阐述理由及相应的科学依据，并依据产品的具体特性对注册申报资料的内容进行充实和细化。
This Guideline is the general requirements for stability study of passive implantable medical devices. The applicant shall determine whether the specific contents herein are applicable according to the characteristics of specific products. If not applicable, the applicant shall explain the justification for such inapplicability and the corresponding scientific basis, and supplement and refine the registration application dossiers according to specific characteristics of the product.
