CFDA released medical devices QM for regulatory guidance

Medical Devices Directory Forums News & Gossips CFDA released medical devices QM for regulatory guidance

This topic contains 0 replies, has 1 voice, and was last updated by Profile photo of Global Medtech Global Medtech 5 months, 2 weeks ago.

Viewing 1 post (of 1 total)
  • Author
    Posts
  • #3131
    Profile photo of Global Medtech
    Global Medtech
    Participant

    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.

    Share
Viewing 1 post (of 1 total)

You must be logged in to reply to this topic.

Share