医疗器械FDAUDI食品FDA化妆品FDAVCRP注册化妆品CPNP 加拿大化妆品通报ISO13485体系建立medical device purchasing agent, China medical device sourcing, 

    医疗器械UDI医疗器械FDA化妆品FDAVCRP化妆品CPNP通报|

    网站首页 > ENGLISH > Regulatory > Medical Devices

    Quality management and Compliance for medical device

    Medical devices manufacturer and distributor must establish and follow the medical device quality management system, the quality management system are known as Good Manufacturing Practices (GMP) for manufacturer and Good Supplier Practices (GSP) for distributor.

    China has implemented the GMP on sterile and implantable medical devices from Jan, 1st 2011 and it will be expanded to all medical devices manufacturing until Jan. 1st 2018 according to CFDA notice No.15-2014. The more information about the GMP implementation in China can be found here.

    On Dec, 12th 2014, CFDA released the 58th Announcement on the implementation of GSP. It indicated that all distributors were required to establish the quality management system corresponding to the GSP to ensure the quality safety in the process of procurement, inspection, storage, transportation, sale, after-sale service.

    GMP and GSP implementation timelines

    TypeImplementation date
    GSPAll medical device distributing

    Dec, 12th 2014

    GMPSterile and implantable medical devices manufacturingJan, 1st  2011
    New establishment or update of manufacturing license for class III medical devicesOct. 1st 2014
    Class III medical devices manufacturingJan, 1st 2016
    All medical devices manufacturingJan, 1st 2018

    How to comply with the quality management regulations in China?

    Quality management shall involve in the full product lifecycle. Companies need to know what obligations or regulations to fulfill firstly, then to establish your own appropriate quality management system and follow it.

    Powered by MetInfo 5.3.19 ©2008-2020 www.MetInfo.cn