The cost and timeline to obtain NMPA (National Medical Products Administration) registration for medical devices in China can vary widely depending on several factors, including the device classification, complexity, and completeness of the submission. Here’s a general overview:

Cost:

1. Application Fees: The NMPA charges application fees for registration, which vary depending on the classification of the medical device. Fees can range from several thousand to tens of thousands of RMB (Chinese Yuan). Exact fees can be found on the NMPA's official fee schedule.

2. Consultancy Fees: Many companies choose to work with regulatory consultants or agents in China to navigate the registration process. Consultancy fees can vary based on the scope of services provided and the complexity of the submission.

3. Testing and Certification Costs: Costs associated with testing, clinical evaluations (if required), and obtaining ISO 13485 certification (if not already certified) should be factored in. These costs vary depending on the testing requirements and the chosen testing laboratories.

Timeline:

1. Preparation Phase: The timeline starts with preparing the necessary documentation, which can take several weeks to months depending on the completeness of existing documentation and the need for additional testing or clinical data.

2. Submission: Once all documentation is prepared and submitted, the NMPA will conduct a technical review. This review process typically takes several months, depending on the workload and complexity of the submission.

3. On-Site Inspection (if required): If an on-site inspection is deemed necessary by the NMPA, this can add several months to the timeline, as it involves scheduling, preparation, and the actual inspection.

4. Approval: Upon successful completion of the review and any required inspections, the NMPA will issue a registration certificate. The timeframe for approval can vary but typically ranges from 6 months to over a year, depending on the device classification and the efficiency of the submission process.

Additional Considerations:

• Updates and Amendments: Any changes to the device or its manufacturing process after registration may require notification or approval from the NMPA, which can incur additional costs and time.

• Local Representation: Working with a reputable local representative or agent in China can help streamline the process and ensure compliance, but this may also add to the overall cost.

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