• Regulatory NewsRegulatory News

    Major Changes to Medical Device Registration Process in Japan

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Revised medical device registration and approval requirements in Japan will become law 25 November 2014 and will impact several compliance areas for foreign manufactures active in the market, according to Emergo’s Tokyo office. Replacing the Pharmaceutical Affairs Law (PAL), the Pharmaceutical and Medical Device Law (PMDL) will ...
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    EU Notified Bodies Update Code of Conduct

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms. First implemented by Team-NB in early 2013, the Code of Conduct’s version 3.2 makes more explicit processes and procedures Notified B...