Guideline for Stability Study of Passive Implantable Medical Devices (Revised in 2022)
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.
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.
This Guideline is a guiding document for the registration applicant and technical reviewer which excludes the administrative matters involved in the review and approval, and shall not be enforced as regulations. This Guideline shall be applied on the premise of complying with relevant regulations. Other methods in compliance with relevant regulatory requirements may also be adopted, but detailed research data and verification data shall be provided. If other regulations and guiding documents address specific requirements for stability studies of certain types of medical devices, it is recommended that the registration applicant use them in conjunction with this guideline. For the stability study of the drug part of drug-device combined medical devices, it is recommended to refer to the relevant guiding documents of the drug.