NMPA certification itself does not include regular maintenance. However, maintaining compliance involves several ongoing responsibilities:
Periodic Reviews: Regular updates and renewals of certification may be required, including submission of annual reports or updates to the NMPA.
Post-Market Surveillance: Manufacturers must monitor device performance, report adverse events, and ensure continued compliance with Chinese regulations.
Quality Management System: Continuous adherence to the quality management system, including regular audits and inspections, is necessary.
Updating Documentation: Any changes in the device or its usage must be reported to the NMPA, and relevant documentation should be updated.
Re-certification: Depending on device type and changes in regulations, re-certification or additional approvals might be necessary.
Ensuring ongoing compliance helps maintain the device’s market authorization in China.
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