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Free sales certificate (‪#‎FSC‬) from ‪#‎UK‬ will now be issued from ‪#‎MHRA‬. If you are a manufacturer outside ‪#‎EU‬ then you should have a EAR based out of UK who can apply on your behalf .

Every #medical #device regardless of its classification needs clinical evaluation for getting itself #CE #marked . This essentially means that even every class I product also requires Clinical evaluation. It is more likely that the manufacturer will follow the literature review method for meeting this requirement.

Feel free To Contact Us #meddevices

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Successful Product registration for CLASS I #Medical #Device  in #Europe  done for #Zuche #Pharmaceutical with HPRA  for their products
Sodium bicarbonate ear drop 10ml 
kliarvax sodium bicarbonate ear drop 5% w/v 10 ml
kliarvax sodium bicarbonate ear drop 5% 10 ml 

For more information

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