The expected approval time for a China NMPA certification application typically ranges from 6 months to over a year, depending on several factors:

1. Device Classification: Class I devices usually have shorter review times, while Class II and III devices may take longer due to more extensive evaluations and potential clinical trials.

2. Completeness of Application: A well-prepared application can expedite the review process, while incomplete submissions may cause delays.

3. Technical Complexity: More complex devices may require additional scrutiny and longer review times.

4. Regulatory Changes: Changes in regulations or increased workload at the NMPA can also impact approval timelines.

5. Inspections: If an on-site inspection is required, it may add to the overall time.

It's advisable to plan for potential delays and engage local experts to navigate the process effectively.

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