• MARCH 2, 2018
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    Does Private Labelling still exist?

    Does Private Labelling still exist?

    Does Private Labelling still exist? In the medical device world often already certified products are being bought by companies with the intention to bring them onto the European market under their own trade name. This is commonly known as bringing a product onto the market under private label or plainly private labeling. Whereby the Original

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    • JUNE 7, 2017
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    CFDA Medical Device Certification China

    CFDA Medical Device Certification China

    For the CFDA Medical Device Certification the China Food and Drug Administration (CFDA) recently released the 2016 Annual Report for National Medical Device Adverse Event Monitoring, which includes the general situation of medical device adverse event reporting, the statistical analysis of medical device adverse events, the intensive monitoring of medical device adverse event,the quality assessment

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    • JUNE 3, 2014
    • 0
    Additional requirements for RoHS Directive

    Additional requirements for RoHS Directive

    The new European Union RoHS Recast Directive that comes into force on July 22 applies to all medical devices. The devices have to comply with some restrictions on certain metals that can become toxic and leach into groundwater, or become hazardous ash when incinerate. The banned materials include lead, cadmium, mercury and polybrominated flame retardants,

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