The certification validity period for medical devices registered with the NMPA (National Medical Products Administration) in China typically depends on the classification of the device:
Class I Medical Devices:
- Validity: Generally 5 years.
Class II and Class III Medical Devices:
- Validity: Generally 4 years.
These validity periods are subject to renewal upon expiration. Renewal requires submission of updated documentation and compliance with current regulatory standards and requirements. It's important for manufacturers to monitor the validity of their certifications and initiate renewal processes well in advance to avoid disruptions in market access for their medical devices in China.
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