Is annual review required for Class I medical device registration with China NMPA?
Release time:2024-07-30 14:41:41 The author: source:
Low Risk Classification: Class I medical devices are considered low-risk and non-invasive. They undergo a less stringent regulatory process compared to higher-risk classes (such as Class II and Class III devices). Once registered, Class I devices are generally not subject to annual reviews unless there are specific regulatory changes or updates that affect their registration status.

No, an annual review is generally not required for Class I medical device registration with China's National Medical Products Administration (NMPA). Unlike higher-risk classes of medical devices, Class I devices typically do not require routine periodic review or renewal of their registration certificates.

Here’s why:

  1. Low Risk Classification: Class I medical devices are considered low-risk and non-invasive. They undergo a less stringent regulatory process compared to higher-risk classes (such as Class II and Class III devices). Once registered, Class I devices are generally not subject to annual reviews unless there are specific regulatory changes or updates that affect their registration status.

  2. Registration Validity: The registration certificate issued by the NMPA for Class I devices is typically valid indefinitely, as long as there are no significant changes to the device design, manufacturing processes, or other critical aspects that would necessitate updating or re-evaluating compliance with regulatory requirements.

  3. Post-Market Surveillance: While annual reviews are not required, manufacturers are responsible for post-market surveillance activities. This includes monitoring the performance and safety of their devices in the market, promptly reporting adverse events, and complying with any regulatory updates or requirements that may affect device safety or efficacy.

  4. Regulatory Updates: Manufacturers should stay informed about any changes in Chinese regulations that may impact their devices. It's important to comply with these updates and maintain communication with the NMPA or your local agent in China to ensure ongoing compliance.

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