GB/Z 130-2025
ActivePost-market surveillance of medical devices for manufacturers
制造商对医疗器械的上市后监测
Application Summary AI generated
This standard provides manufacturers with a framework for systematically collecting, analyzing, and acting on data about medical device performance after they are placed on the market. It is applied in the healthcare industry to ensure ongoing safety and effectiveness, guiding activities such as complaint handling, trend analysis, and the implementation of corrective actions. The standard is relevant for all medical device manufacturers operating in China, covering both domestic and imported products.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.