Government-Based Regulation:

In Egypt, there are legal provisions establishing the powers and responsibilities of the Medicines Regulatory Authority (MRA). The MRA is a part of the MoH with a number of functions outlined in Table 6. The MRA has its own website: http://www.eda.mohp.gov.eg The Egyptian Drug Authority (EDA) is the pharmaceutical regulatory body of the Egyptian Ministry of Health.

EDA has three sub-organizations: CAPA, NODCAR, and NORCB. There is mixing of roles between the MOH and MOHE regarding regulation and service provision of the 3 main services related to health, which are treatment, education and professional development, and research. Although the Egyptian Financial Supervisory Authority is the main party responsible for regulating the insurance market, a substantial part of the health insurance activities in Egypt are not regulated by it. These overlaps, vagueness and lack of coordination violate the whole accountability framework of the industry and hamper its growth. Information asymmetry, selective disclosure and abuse of confidentiality are major happenings within such a framework.

Market-based regulation

As the healthcare industry is not fostering competition, there are very few systems for market-based regulations. There are also very few civil society organizations like reputational agencies, whistle-blowers, customer and patient rights organizations functioning in Egypt.

Registration Process

1)      The Drug Policy & Planning Center (DPPC) of the MoHP requires the following documents in order to register and approve medical devices and equipment:

2)      Original Free Sale Certificate (issued by official health authorities in the country of origin, stating that the product is freely sold), certified by both the Chamber of Commerce and Egyptian Embassy/Consulate.

3)      Copy of Pro-forma Invoice.

4)      Copy of FDA approval (Certificate to Foreign Government) certified by the Egyptian Embassy/Consulate (importer may be required to show the “original” certificate for confirmation).

5)      Copy of the legalized Agency Agreement.

6)      Certificate of Origin (in case of exporting components to a factory for local manufacture/assembly).

7)      Declaration of Conformity (in case of class 1 non-sterile devices, non-measuring product or equipment).