Middle East Medical Device Registration
The Middle East & North Africa (MENA) region consist of three general sub-regions
Arabian Peninsula: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates (UAE) and Yemen. This region is also defined as Cooperation Council for the Arab States of the Gulf (GCC).
Western Asia: Iran, Iraq, Israel, Jordan, Lebanon, Palestin and Syria;
North Africa: Algeria, Libya, Morocco, Tunisia.
As the countries covered in this region is wide, the regulatory control is different from each countries.
Even the authentication documents are separated into different terms and its process also has to be understood by the overseas manufacturer for the preparation in their own country with the Embassy or Consulates.
ARQon team from regulatory in manufacturing facility understood the process of the authentication with the Embassy/Consulates/Chamber and product registration approval with the Regulatory Authorities. Some of the documents for submission to the Regulatory authorities have to be authenticated.