The regulatory requirements imposed on the local manufacturers and importers vary among the Middle East countries.  Some follow the major principals of the USA or the EU regulations while others have integrated further requirements within their legislations.

In some countries, CE mark or FDA clearance is a pre-condition to import medical device into that country.  In other countries the local regulation process is either fragmented or cumbersome that many of the local manufacturers seek CE mark or US FDA clearances first before approaching their local authorities with a request for local sales clearance.