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- SFDA Guidelines: Adhere to SFDA guidelines and requirements for periodic updates and changes. These guidelines outline the processes for updating registration information, including device modifications and administrative changes.
- Monitor Device Performance: Continuously monitor the device's performance and safety in the market. Collect and analyze data on device use and effectiveness.
- 2024-09-06Confirm Device Classification: Verify that your device is accurately classified as Class B according to SFDA guidelines.
- This standard specifies requirements for a quality management system (QMS) that demonstrates an organization’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
- Ongoing Compliance: Ensure continued compliance with SFDA regulations, including maintaining quality management systems and adhering to labeling requirements.
- 2024-09-06Detailed Description: Include information on the device’s intended use, functionality, and design.
- Completeness of Application: A complete and accurate submission can expedite the review process, while incomplete or incorrect applications may cause delays.
- Ensure that your device is correctly classified as Class B according to SFDA guidelines.
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