Yes, multiple certification and approval processes can be involved for NMPA-registered medical devices in China, depending on the nature of the device and the changes made:
Initial Registration: This process involves obtaining the primary approval for the medical device, including technical reviews, testing, and inspections.
Clinical Trials: For certain devices, especially Class III devices, clinical trials may be required to demonstrate safety and efficacy.
Changes and Updates: Significant changes to the device or its manufacturing process require additional approval. This might involve submitting new documentation or undergoing further review by the NMPA.
Renewals and Re-certifications: Periodic renewals of the registration might be necessary, involving updates to documentation and re-evaluation of the device.
Each process aims to ensure that the device continues to meet regulatory standards throughout its lifecycle.
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