The certification approval period for NMPA (National Medical Products Administration) registration in China can vary depending on the type of medical device and the completeness of the application. Generally, the process takes:
- For Class I Devices: Around 1 to 3 months.
- For Class II Devices: Approximately 6 to 9 months.
- For Class III Devices: Usually between 9 to 12 months, but it can take longer for complex devices.
These timelines can fluctuate based on factors like the complexity of the device, the quality of the submitted documents, and the current workload of the NMPA. It’s important to ensure that all required documentation is complete and accurate to avoid delays.
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