The NMPA released eleven filing review guidelines on September 1, 2022. Equivalent to FDA’s Acceptance and Filing Reviews, it is intended to be used by NMPA reviewers and the device industry to help elucidate the broad clinical and registration issues that need to be addressed in the submission and key decisions to be made during the filing process.
Focusing NMPA’s review resources on complete applications will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. “Medical Device Registration and Filing Management Measures” regulates that if the applicant needs to supplement for deficiency and correct materials during the technical review process, the technical review agency shall notify all the contents that need to be supplemented and corrected at ONE TIME. The applicant shall provide supplementary materials at ONE TIME within one year.
The Full List of the NMPA Filing Review
Eleven documents are published:
- Medical device registration filing review requirements
- Medical device modification registration filing review requirements
- Filing review requirements for medical device exempted from clinical evaluation catalog
- Medical device clinical evaluation file review form
- In vitro diagnostic reagent registration filing review requirements
- In vitro diagnostic reagents modification registration filing review requirements
- Filing review form for In vitro diagnostic reagents clinical evaluation (Non-clinical Trials)
- Filing review form for In vitro diagnostic reagents clinical evaluation (Clinical Trials)
- Filing review requirements for medical device clinical trial application
- Filing review requirements for medical device renewal registration
- Filing review requirements for in vitro diagnostic reagent renewal registration
For English copies of the documents above, please email info@ChinaMedDevice.com.
Key Contents Guideline
The documents contain the key information as below:
- Relevant Description:
describe the purpose, general idea, and relationship with the review.
- Usage Description:
describe the personnel, division of labor, and basic requirements for filling in. The reviewers are required to describe in detail all the problems existing in each review item. These problems will be notified to the applicant/registrant in the supplementary notice.
- Applicable Registration Guidelines and Mandatory Standard Identification
used as a record of information to help reviewers sort out their ideas and be used for the quality assessment of filing examinations.
- Basic Review Issues
correspond to “refuse to file” scenario. If this part of the review fails, the reviewers will directly make an
- Overall Review Questions
correspond to several major and general issues that the review should focus on.
- Issues for Filing Examination
correspond to the requirements of normative documents, guidelines, and other documents for submission materials.