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 !
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 !