Clinical validation/investigation in Egypt - Medical Devices sevices that are not marked yet

[RA Lille]

Dear all,

Has anyone info about the documents to provide, authorization to get prior before conducting a clinical validation study pre CE mark or a clinical investigation post CE mark of Medical Devices in Egypt ?

Shall we provide IB (investigator brochure), CIP (Clinical Investigation Protocol), ICF (Informed Consent form) ? shall these documents be in English ? Arabic ?
Whom shall you send these documents ?
Is there any Ethical Comittee opinion to obtain ?

Could any foreign manufacturer conduct clinical investigation in Egypt ?
I saw that EPA, CAPA are responsible for authorizing and controlling MEdical Devices on the market. Probably for CE marked Devices, but what about devices that are not marked yet ?

thanks for sharing any info !

 

[SKM.Sunil]

As Per my Knowledge:

- RECs (research ethics committees) established under the Egyptian Ministry of Health, will review all the documents prior to giving approval to conducting a clinical trial in Egypt.
- If your device is new to the country then You must have/submit a valid clinical evidence (literature with your device if available) to prove the clinical performance with a minimum amount of population size. (Not only this point valid for Egypt but elsewhere in the Globe if Manufacture from a different country)

this link may help you more www.clinicaltrials.mohealth.gov.eg/Guidelines.pdf

All the Best