NMPA revised the current documents regarding “Requirements for Pre-assessment of Medical Device Registration (Draft)” according to “Registration and Filing of Medical Device”, “Registration and Filing of In Vitro Diagnostic Medical Device” and the related circular and announcement.
The completeness and conformity of applications will be evaluated by the Center for Medical Device Evaluation (CMDE) in accordance with the revised requirements for pre-assessment. During pre-assessment, safety, and efficacy of the device as well as risk benefit ratio will not be evaluated. Pre-assessment is applicable for medical device registration, change notification and clinical trial applications etc.
The revised documents are hereby issued and come into force from the date of publication. The announcement “NMPA’s Notice on the documents regarding Requirements for Pre-assessment of Medical Device Registration (Draft)” No. 42 of 2019 shall be abolished at the same time.
Attachment:
- 1. Requirements for Pre-assessment of Medical Device Registration
- 2. Requirements for Pre-assessment of Medical Device Change Notification
- 3. Requirements for Pre-assessment of Medical Device Comparison Content for Clinical Trial
- 4. Requirements for Pre-assessment of Medical Device Clinical Evaluation
- 5. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Registration
- 6. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Change Notification
- 7. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Clinical Evaluation (Not Clinical Trial)
- 8. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Clinical Evaluation (Clinical Trial)
- 9. Requirements for Pre-assessment of Medical Device Clinical Trial Application
- 10. Requirements for Pre-assessment of Medical Device Renewal Registration
- 11. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Renewal Registration