GB/T 42061-2022
ActiveMedical devices—Quality management systems—Requirements for regulatory purposes
医疗器械 质量管理体系 用于法规的要求
Application Summary AI generated
This standard specifies requirements for a quality management system specific to the medical device industry, covering the design, development, production, and post-market surveillance of medical devices. It is applied by manufacturers and regulatory bodies in China to demonstrate compliance with national regulatory requirements, ensuring product safety and effectiveness throughout the device lifecycle. The standard is used for certification, auditing, and market access purposes within the Chinese medical device sector.
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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.