Egyptian Drug Authority

 
Services > Drug Policy & Planning Center > Planning and Approvals to Import Medical Devices > Link-Rules for importation approvals of diagnostic laboratory equipments

Link-Rules for importation approvals of diagnostic laboratory equipments

  In case the instrument follows the In vitro diagnostic directive 98/79/EC, MOH requires declaration of conformity and free sale from
    country of origin.
  In case the instrument does not follows the In vitro diagnostic directive 98/79/EC,It may go under one of the following tracks:

  1. If the instrument is purchased by medical clinic, hospital or any medical establishment, MOH requires declaration of conformity and free 
    sale from country of origin.
  2. If the purchasing institution is not medical, MOH will not issue any approval rather it will consider the instrument "Out of scope".

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