After obtaining NMPA certification in China, the safety review strategy for medical devices involves several key components:

1. Post-Market Surveillance: Continuous monitoring of the device’s performance and safety in the market. This includes collecting and analyzing data on adverse events and device failures.

2. Periodic Reporting: Regularly submitting safety reports to NMPA, including updates on any issues or incidents related to the device.

3. Clinical Follow-Up: Conducting post-market clinical follow-up studies, if required, to gather additional safety and efficacy data.

4. Recalls and Corrective Actions: Implementing measures for recalls or corrective actions if safety issues are identified. This includes notifying NMPA and taking steps to address the problems.

5. Compliance with Standards: Ensuring ongoing compliance with Chinese standards and regulations, including any updates to safety and quality requirements.

6. Training and Education: Providing ongoing training for healthcare professionals and users to ensure proper use and handling of the device.

These guidelines help maintain device safety and performance throughout its lifecycle in the Chinese market.

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