The cost of applying for NMPA registration for medical devices exporting to China can vary significantly based on several factors, including the type of device, its classification (Class I, II, or III), and the specific testing and documentation requirements. Generally, the costs can range from:

1. Application Fees: NMPA application fees can vary, typically starting around a few thousand RMB for Class I devices and increasing substantially for Class II and III devices.

2. Testing and Certification Costs: Fees for testing at NMPA-recognized laboratories can range from tens of thousands to hundreds of thousands of RMB, depending on the complexity of the device and the number of tests required.

3. Consulting Fees: If you engage regulatory consultants to assist with the application process, their fees can also add several thousand RMB.

4. Quality Management System (QMS) Costs: Achieving ISO 13485 certification, if not already obtained, can incur additional expenses.

5. Translation and Documentation Costs: Preparing and translating necessary documentation into Chinese may add to the total cost.

Estimated Total Costs

Overall, the total cost for NMPA registration can range from approximately 50,000 to 300,000 RMB or more, depending on the specifics of the application and device. It's advisable to consult with local experts for precise estimates tailored to your situation.

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