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YY/T0287-2017 "Medical devices--Quality management systems--Requirements for regulatory purposes" of

2017-02-07 

On January 19, 2017, China Food and Drug Administration issued YY/T0287-2017/ISO13485:2016 "Medical devices--Quality management systems--Requirements for regulatory purposes", which will come into force as of May 1, 2017.

YY/T0287-2017 idt ISO13485:2016 further stresses regulation, emphasizes the importance and necessity of implementing regulatory requirements, improves the compatibility of regulations and the standard; defines that the quality management system standard is applicable to medical device organizations at all stages of the full life cycle industrial chain, further guarantees the safety and effectiveness of medical devices at all stages of the full life cycle; intensifies the new requirements based on risk analysis and risk management; advances new requirements to medical device supply chain and procurement; and adds new requirements on the post-market surveillance and improvement of medical devices.
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