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Chinese Regulators Plan Surprise Inspections for Medical Device Facilities

Discussion in 'China Medical Device Regulations' started by nikolaos, Aug 11, 2015.

  1. nikolaos

    nikolaos Member

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    Hi All,
    I want to share the following information:

    The China Food and Drug Administration (CFDA) will begin a new program of unannounced inspections beginning September 1, 2015 for medical device manufacturers registered to market their products in the country.

    According to the CFDAorder(link in Chinese), the inspections may cover quality management system and all related research, production and development processes for medical devices registered for sale in China. Inspections are warranted in cases such as:

    · Complaints of a device’s quality or safety occur

    · Improper or inadequate adverse event reporting

    · Serious violations of quality system compliance

    · Other quality or safety risks involving a device are suspected

    In instances where investigations yield problems or violations, CFDA may undertake disciplinary actions including warning letters, additional investigations, product recalls or revocation of quality system certification.

    The legal basis for surprise regulatory inspections of medical device firms was established in 2012 under the Working Procedures for Unannounced Inspection of Medical Device Manufacturers,which was set by the CFDA's previous iteration, the State Food and Drug Administration.

    http://eng.sfda.gov.cn/WS03/CL0757/72894.html

    Greetings
     
  2. hlnkrystal

    hlnkrystal New Member

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    Hi can i know this is applicable to all medical devices class risks? Also the inspection was to the oversea manufacturer?
     
  3. nikolaos

    nikolaos Member

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    Hi,
    Sorry but I don't have more information. If you speak Chinese try this link order
     

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