1. Definitions
In case of any change to the Registration Certificate for Class II and III Medical Devices and its attachments, the applicant/registrant shall apply with the original registration authority for the change, and submit the registration dossiers.
2. Types of change
(1). Changes of permission items:
Changes in name and domicile of the applicant/registrant or agent in the registration certificate.
Production address change of domestic medical devices.
(2). Changes of registry items:
Change in the product name, model and specification indicated in the Registration Certificate and its attachments.
Change in the structure and components, scope of application and product technical requirements.
Production address change of imported medical devices.
Changes of corresponding content in the column “Other Content”.
3. Handling process of registration changes
4. TIPS
For the online route (eRPS system): the application for changes to registration matters or licensing matters can be applied for in the same application form. In the case of merged changes, the acceptance number of the changes is still distributed in accordance with the current process, and the electronic catalogue is automatically associated to the changes to licensing matters. The changes of registration matters should be associated to the “CH2.7 Other Reporting Summary Information” of the electronic catalogue of imported medical devices.
For the offline route: the registrant shall fill out forms and prepare materials respectively for the change of registration matters and of licensing matters.
The Change Notification for Registered Medical Device shall be pooled with the original Medical Device Registration Certificate, having the same valid period.
After receiving the Change Notification, the applicant/registrant should modify its product technical requirements, IFUs and labels individually according to the changed content.
To change any matters outside the scope of approval, the enterprise shall also go through validation and verification of changes according to system requirements and reserve the files for future reference.
