1. Notification on IFU Changes
For approved medical devices, Notification of IFU Changes refers to the process that the registration authority will, after the IFU is modified upon approval, notify the Department of Medical Device Registration, NMPA or provincial Medical Administration Department that the changes, excluding the content in the Medical Device Registration Certificate and its attachments are approved.
2. Three review results
Approve
Partially approve
Disapprove
3. Application procedures
Online(eRPS system):The applicant/registrant submits the application dossiers through eRPS system.
Offline: An applicant/registrant shall make an application to the National Medical Products Administration according to the requirements for application dossiers of Notification on IFU Changes.
4. Tips
Applicant/registrant can follow the progress of registration approval through the module of “Query for Comprehensive Administrative Licensing Matters” on the website of the National Medical Products Administration.
Applicant/registrant can view the “Announcement on Releasing the Notice Letter of Disapproved IFU” on the page of ” Delivery information ” of the service module of the National Medical Products Administration.
The National Medical Products Administration is deemed to approve the registration if it fails to make a reply within the specified time limit.
