To delve into the application procedure for NMPA registration of Class II medical devices, you typically need to follow these steps:
Preparation: Gather all required documents, including a product technical file, clinical data (if applicable), and manufacturing details.
Submission: Submit an application to the NMPA through their online system or in-person, including all required documentation.
Review: The NMPA reviews the application, which may involve additional questions or requests for more information.
Inspection: An on-site inspection of the manufacturing facility might be required.
Approval: Once everything is satisfactory, the NMPA issues a registration certificate.
Do you need details on any specific part of this process?
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