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  • Medical device manufacturers must follow labelling requirements and appropriate labelling must be done on all Medical Devices before placing them in Indian Market. Rule 109A of Medical Device Rules, 2017 gives instructions for labelling of Medical Devices ...

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    Procedure Packs in the UK

    This message was posted by a user wishing to remain anonymous Hello, I am working the Technical File for a Procedure Pack in the UK. Does anyone have guidance on the following: Due to the extension of the legislation, are all components in the procedure ...

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    India Importer Label Class B Medical Device

    This message was posted by a user wishing to remain anonymous Hi Everyone, Our company is trying to import a device into India.  It is a class 1 Device in EU and FDA.  We are based in UK and have design control and all product liability, but the device ...

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    Disposal of clinical products

    This message was posted by a user wishing to remain anonymous Dear reg specialists,  I am seeking your advice on the following.  Are there any environmental requirements that IVDs manufacturer needs to be aware of for the disposal of clinical products? ...

  • This past summer, Korea issued article 43-6 of the Medical Device Act, requiring medical device manufacturers and importers to obtain liability insurance for patient claims of injury or death. For now, only manufacturers or importers of implantable device ...

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