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  1. Legal news
    17 November 2015
    CJEU rules on non-corrective colour contact lenses
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/cjeu-rules-on-non-corrective-colour-contact-lenses

    The effect of the ruling is that the Cosmetic Regulation must be interpreted such that contact lenses marketed purely to alter the user's appearance (rather than to correct vision) will not be within its scope even if ...

  2. Legal news
    17 November 2015
    Chinese authorities announce reform of pharmaceutical and medical device approval system
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/chinese-authorities-announce-reform-of-pharmaceutical-and-medical-device-approval-system

    The long awaited and wide-ranging Opinions on Reforming the Review and Approval Process for Drugs and Medical Devices (the 'Opinions'), were recently issued by China's State Council, and set out a series of measures ...

  3. Legal news
    17 November 2015
    Medical devices liability update
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/medical-devices-liability-update

    This update discusses the most recent development in this saga: the decision of the Court of Appeal of Aix-en-Provence (delivered on 2 July 2015) and its implications.

  4. Legal news
    17 November 2015
    Chinese authorities announce surprise inspections of medical device and pharmaceutical manufacturers
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/chinese-authorities-announce-surprise-inspections-of-medical-device-and-pharmaceutical-manufacturers

    According to a recent announcement by the China Food and Drug Administration (the 'CFDA'), pharmaceutical and medical device manufacturers should in the future expect regular surprise inspection visits from officials.

  5. Legal news
    17 November 2015
    Hong Kong government renews commitment to the introduction of a regulatory regime for medical devices
    www.twobirds.com/en/news/articles/2015/global/life-sciences-november/hong-kong-government-renews-commitment-to-regulatory-regime-for-medical-devices

    he Secretary for Food and Health has stated that the Hong Kong government (the Administration), will soon complete a study on how to regulate high-risk medical devices. It is expected that the proposed regulations will ...

  6. Legal news
    03 September 2019
    China Expands Medical Devices Market Authorization Holder Pilot Project to 21 Provinces/Municipalities
    www.twobirds.com/en/news/articles/2019/global/china-expands-medical-devices-market-authorization-holder-pilot-project-to-21-provinces

    On 1 August 2019, the National Medical Products Administration ("NMPA") issued a notice to extend the pilot project of medical device registrant system (GUO YAO JIAN XIE ZHU (2019) No.33) ("Notice") to 21 ...

  7. Legal news
    27 August 2015
    Medical apps and regulation: a perspective from Denmark
    www.twobirds.com/en/news/articles/2015/denmark/medico-apps-and-regulation

    If an app is considered to be a diagnostic and/or therapeutic tool, the app is no longer "just an app", it is to be regarded as a "medical device", which gives rise to the imposing of certain legal obligations.