Regulatory Affairs
Approval Medical Devices: Middle East and Africa
A successfully completed conformity assessment procedure in the home market of Europe can not only be a basic prerequisite for placing medical technology on the market in this country. It can also be the chance for approval of medical devices and IVDs in other countries in the Middle East or Africa.
EMEA - Economic Area Europe, Middle East and Africa
EMEA stands for Europe, Middle East and Africa and is the abbreviation for one of the three economic areas on earth. Unfortunately, the only thing the EMEA countries have in common is the same stock exchange trading time zone - The search for a uniform approval strategy for Medical Devices is unfortunately a constant search.
Don't forget the invitation letter for auditing your manufacturing sites when registering in Nigeria!
Approval of Medical Devices in Africa
Are you aware of the number states that encompasses Africa? The continent is comprised of 54 states, of which, each, more or less are accompanied with its own rules for Medical Device registration. Nigeria is the largest economy in Africa with 448.1 billion USD and has clear requirements for registration. The Nigerian NAFDAC website offers their guidelines for download, but how is one expected to register a product in Algeria, Ethiopia or South Africa?
Medical Device approval in the Middle East
Which countries exactly belong to the Near or Middle East can vary, depending on your point of view. Typically, and from a regulatory stance, countries such as the Arab Emirates or Israel are in any case highly intriguing and offer great potential for European Medical Device manufacturers. While Israel has a very well-developed medical technology sector, the Omar and Qatar rely primarily on imports from the EU.
Requirements for the approval process in the Middle East and Africa
The following solvent countries in the middle east as well as emerging countries in Africa are appealing pertaining to their markets for the export of Medical Devices:
- Saudi Arabia
- United Arab Emirates
- Israel
- Egypt
In many countries in the Middle East and Africa, the CE mark is sufficient to place medical devices on the market there. But slowly more and more countries are creating their own regulations based on European and American laws.
Are you aware of which solvent importing country in the Middle East will be the first to introduce a UDI in this area? We are. Saudi Arabia is the first country to introduce a UDI based on American and European models. We are experts in this area and are happy to help you.
qtec as your partner
We will guide you through the complex requirements in Africa and Middle East and figure out the best possible way to gain market access. Our specialists are always up to date and know about the latest changes in regulation framework of promising markets.
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