NMPA Rejected Registration And Initiative Revocation Of Registration Application

1.Rejected registration

(1). Interpretation on “Rejected Registration”

After the technical evaluation and/or administrative approval, the devices shall not be allowed for registration, if the application for registration of medical devices is deemed as unable to prove the safety, effectiveness or non-compliance with the requirements of laws and regulations.

(2). Common circumstances of rejected registration

Application dossiers for registration are false.

The contents of application dossiers for registration are disordered or confusing.

The contents of application dossiers for registration are obviously inconsistent with the application matters.

The project for registration application does not involve a medical device.

The applicant does not apply in accordance with the prescribed registration form.

The registration quality management system inspection result is that the medical device fails to pass verification after inspection or rectification.

(3). Common circumstances of rejected registration renewal

The applicant/registrant fails to submit the application within the prescribed time limit.

The mandatory standards for medical devices have been revised, and the product fails to meet the new requirements.

For medical devices required for the treatment of rare diseases or urgently needed to respond to public health emergencies, the items specified in the Medical Device Registration Certificate have not been completed within the prescribed time limit.

(4). Terminated evaluation

If the applicant/registrant fails to submit supplements and amendments within the prescribed time limit (within one year), the evaluation will be terminated, in which case the Center for Medical Device Evaluation will come up with a disapproval suggestion.

2.Initiative revocation of registration application

(1). An applicant/registrant may initiatively withdraw the submissions for any registration application prior to the administrative decision. The applicant shall apply to the Center for Administrative Services and Complaints of the National Medical Products Administration for initiative revocation of application for medical device registration/registration modification/registration renewal/re-evaluation.

(2). Address: Building No. 1, Courtyard No. 50, Qixiang Road, Haidian District, Beijing Municipality.

(3). The Department: Group for Materials of the Department of Comprehensive Affairs.

(4). Tel: 010-86452930.

3. TIPS

Where an enterprise revokes the application initiatively, the paid registration fees will not be refunded.

When the devices were not allowed for registration, the corresponding application dossiers cannot be retrieved.

When the evaluation was terminated, the corresponding application dossiers cannot be retrieved.