Regulatory Affairs for EGYPT

Now, Alshedwy Group in Egypt,

Alshedwy Group, Egypt. through its local office in Cairo is working for you as your Authorized Representative and Registering Agent (Egypt Registation Holder, ERH).

Alshedwy Group, Egypt. will be responsible as your Auth. Rep. for compiling the proper technical file (Dossier) for your MD and/or IVD, packing for an official meeting with the regulatory authority in Egypt, namely the Central Administration of Pharmaceutical Affairs (CAPA), Introduse the Dossier and conducting the scientific negotiation for getting the Marketing Approval for your products.

Regulations of MD market in Egypt is some how hard, it needs experienced person to conduct the meeting with the CAPA and guarantee not to need many trials for such introduction to save time, money and labour.

Alshedwy Group, EGYPT. offers overseas manufacturers of MDs and IVDs competitive rates and dedicated experts As your Auth. Rep. and Registering agent

Tasks we perform as your medical device representative in Egypt

Alshedwy Group, EGYPT maintains an office in Cairo, and is fully capable of acting as your independent ERH. Our ERH service for foreign medical device manufacturers in Egypt includes the following:

  • Submission of all registration materials to the CAPA
  • Assist with Scientific Committee reviews, if required
  • Notifying CAPA whenever changes are made to your device
  • Assisting with any adverse event reporting or field safety corrective actions, if necessary
  • Assisting with your device registration renewals, required every 10 years

Ask for free proposal for our Egyptian Registration Holder service.

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