GB/Z 130-2025 Post-market surveillance of medical devices for manufacturers

Scope

This document provides guidance on the post-market surveillance process for medical device manufacturers. The post-market surveillance process complies with relevant standards, particularly GB/T 42061 and GB/T 42062. This document describes a proactive, systematic process that manufacturers can use to collect and analyze appropriate data, provide information for the feedback process, and meet applicable regulatory requirements. The output of this process can be used for:
—— As input for product realization;
—— As input for risk management;
—— To monitor and maintain product requirements;
—— To communicate with regulatory authorities; or
—— As input for improvement processes.
This document does not address market surveillance activities conducted by regulatory authorities. This document does not specify measures required by manufacturers in accordance with applicable regulatory requirements arising from production or post-production activities, nor does it specify reporting to regulatory authorities. This document does not replace or modify applicable regulatory requirements for post-market surveillance.

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