The validity period of NMPA certification for medical devices in China varies by device classification:
Class I Devices: Typically, the registration is valid indefinitely as long as the device remains unchanged and the manufacturer continues to meet applicable regulations.
Class II and III Devices: These certifications are generally valid for five years. After this period, manufacturers must apply for re-registration, which may involve a review of updated safety and efficacy data.
It's essential for manufacturers to monitor their certification status and ensure compliance with any ongoing regulatory requirements to maintain validity.
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