Equivalent to "Acceptance and Filing Reviews" by FDA, NMPA released eleven submission filing review guidelines on September 1, 2022. It was intended to address the broad clinical and registration issues regarding submissions, as well as to help both NMPA reviewers and the medical device manufacturers make key decisions during the filing process.
NMPA will first decide whether to accept the registration dossier based on the evaluation of its completeness, compliance, and uniformity during the filing review process. Therefore, to better guide the applicant through proper registration materials preparation for submission, these guidelines are issued as NMPA's review resources in accordance with the "Medical Device Registration and Filing Management Measures". These guidelines are important to read and understand to save time and efforts. The 11 submission filing review guidelines can alleviate misunderstandings on the submission content and reduce the time needed for the acceptance review of the initial filing. After you pass these initial dossier review in content completeness and compliance in format and essential documents, the dossier will be routed to the technical and clinical formal review.
The Guidelines List
Eleven Guidelines include filing review requirements in registration, modification registration, registration renewal, clinical evaluation, clinical trial of medical devices and IVDs, and filing review forms in clinical evaluation of medical devices and IVDs. Following are the full lists:
- Filing review requirements for medical device registration
- Filing review requirements for medical device modification registration
- Filing review requirements for medical device renewal registration
- Filing review requirements for medical device clinical trial application
- Filing review requirements for medical device clinical evaluation exemption catalog
- Filing review form for medical device clinical evaluation
- Filing review requirements for IVD reagents registration
- Filing review requirements for IVD reagents modification registration
- Filing review requirements for IVD reagents renewal registration
- Filing review form for IVD reagents clinical evaluation (Non-clinical Trials)
- Filing review form for IVD reagents clinical evaluation (Clinical Trials)
Key Contents
The guidelines are in forms of checklists and are segmented into different sections based on requirements for different filing reviews, including relevant description, usage description, Applicable Registration Guidelines and Mandatory Standard Identification, Basic Review Issues, Overall Review Questions, Issues for filing review. Key points to know:
- Usage Description:
The reviewers are required to describe in detail about all the problems existed 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 reference to help reviewers conduct the quality assessment on filing review.
- Basic Review Issues
If the applicant fails this part of the review, the reviewers will directly make an adversary decision.
I would love to hear your feedback and comments on any challenges you have with NMPA initial filing review for your product submission, please feel free to email me.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------