NMPA Technical Review And Approval Procedure Of Medical Devices–Others

1. Re-issuance of registration certificate

(1). A registrant may, free of charge, apply for re-issuance of the registration certificate and/or its attachments and registration documents of the modifications within the valid period of the Medical Device/IVD Reagent Registration Certificate/registration documents of the modifications.

(2). Handling process

The registrant shall submit relevant application to the Administrative Service Hall of the National Medical Products Administration.

Application dossiers that meet the formal examination requirements will be accepted and then transferred to the Department of Medical Device Registration.

The staff of the Department of Medical Device Registration shall offer the examination opinions within 10 working days upon receiving the application dossiers, and the person-in-charge of the division will give his/her review opinions within 4 working days and feedback to the Administrative Service Hall.

The Administrative Service Hall will produce documents according to corresponding opinions within 10 working days, and perform service procedures as required.

2. Correction of registration certificate

(1). In the case of the following corrigendum to the certificate, a registrant may, free of charge, apply for a content error correction of Medical Device Registration Certificate and its attachments:

Typographical errors of registration certificate or registration document of the modifications and its attachments;

An error of Registration Certificate Number;

Filing information error of the enterprise;

Other errors in the work of evaluation and approval.

(2). Handling process

The registrant shall submit relevant application to the Administrative Service Hall of the National Medical Products Administration.

After the application is accepted through formal examination, the case is handled as follows: (i) The Administrative Service Hall will immediately handle the matters with regard to the typographical errors of registration certificate or registration document of the modifications and its attachments; (ii) The case will be transferred to the Department of Medical Device Registration for settlement according to procedures if it involves an error of Registration Certificate Number; (iii) In other circumstances, it will be transferred to the Center for Medical Device Evaluation according to procedures.

With regard to the circumstance (ii), the Department of Medical Device Registration shall offer its examination opinions within 10 working days upon receiving the application dossiers, and the person-in-charge of the division will give his/her review opinions within 8 working days and feedback to the Center for Administrative Services and Complaints within 2 working days. In the case of circumstance (iii), the Center for Medical Device Evaluation will examine the materials according to the requirements and offer its opinions within 30 working days upon receiving the application dossiers, and submit them to the Department of Medical Device Registration for final review.

The Department of Medical Device Registration will finally return the application dossiers to the Administrative Service Hall, which should produce relevant documents according to the approval opinions within 10 working days and perform service procedures as required.

(3). Tips：

Information about error correction will be transferred to the Information Center of the National Medical Products Administration, and will be posted on the website of the National Medical Products Administration.

3. Initiative cancellation of registration certificate

(1). A registrant may initiatively apply for cancellation of the Medical Device/IVD Reagent Registration Certificate/registration document of the modifications which has been within its valid period.

(2). Handling process

The registrant shall submit relevant application to the Administrative Service Hall of the National Medical Products Administration.

Application dossiers that meet the formal examination requirements will be accepted and then transferred to the Department of Medical Device Registration within 3 working days.

The staff of the Department of Medical Device Registration will verify the relevant information and draft the announcement on cancellation within 10 working days upon receiving the application dossiers, the person-in-charge of the division will offer his/her re-review opinions within 5 working days, and then the person-in-charge of the department will conclude his/her validation opinions within 5 working days.

The announcement on cancellation shall be released after approval according to the document release procedures of the National Medical Products Administration.

4. Application for re-review

(1). Where the applicant lodged an objection to the disapproval decision made by the National Medical Products Administration, he/she may apply for a re-review of medical device/IVD reagent registration/change of licensing matters, free of charge.

(2). Handling process

The applicant shall submit re-review application to the Administrative Service Hall of the National Medical Products Administration.

The National Medical Products Administration shall make a decision within 30 working days upon accepting the application and inform the applicant the decision in writing. In the case of maintaining the original decision, the National Medical Products Administration will no longer accept the application for re-review by the applicant.

(3). Tips：

Where the applicant has applied for administrative reconsideration or filed an administrative lawsuit, the National Medical Products Administration will no longer accept the application for re-review.