Regulatory Guideline for Procedures of Registering Imported and Local Medical Devices holding International Quality Certificates
Regulatory Guideline
This guideline is concerned with the regulatory procedures of registering imported and local medical devices that have international quality certificates.
Regulatory Guideline on Requirements for Unique Device Identification (UDI) for Medical Devices
regulatory-guideline
The purpose of this guidance is to define the EDA requirements for UDI for medical devices, their accessories and IVDs according to the provisions of the Egyptian Drug Authority (EDA).
Regulatory guideline of labelling requirements for medical devices, medical and laboratory equipment and In Vitro Diagnostics, components and production inputs
egulatory-guideline
This guide is concerned with the minimum requirements that must be available on the labels of medical devices, medical and laboratory equipment, In Vitro diagnostics for the purpose of circulation in Egypt, and production components and inputs for the purpose of production.