Medical Device Regulations in the MENA Region
As healthcare spending continues to rise in the Middle East and North Africa (MENA), this region is becoming a key growth target for medical device manufacturers. One of the main challenges companies face in the region is navigating the non-harmonised regulatory landscape which contains different systems, requirements and procedures. Having a solid regulatory strategy in the region will require an in depth knowledge of the regulations and can open up a growing market.
This 7 module, 4-week online course will provide you with a complete overview of the regulatory landscape in the region before focusing in on specific countries such as those in the Gulf Cooperation Council (GCC), Egypt, Iran, Lebanon and Jordan. For each country you will examine company registration, product registration, labelling, fees and contact information.
Suitability - Who should attend?
This course would be useful for people within regulatory affairs departments who have local representations in these markets and want to know more about the region. It will provide them with an overview and would allow them to monitor local representatives more thoroughly.
This course would also be good for local representatives wanting to learn more about other countries registrations.
Outcome / Qualification etc.
- Guidance on dossier requirements and structure to avoid rejections and gain faster approval of devices
- Learn about future regulatory developments in the region
- Understand regional and national systems of standards for medical devices
- Learn about the medical device trends in the MENA Region
- Compare key regulatory differences between regulatory submissions in major countries.
- Gain an overview on the markets
- Be clearer on cultural differences
Training Course Content
- Module 1: Introduction to the region
- Module 2: GCC-Saudi Arabia
- Module 3: GCC-UAE,Kuwait
- Module 4: GCC-Oman, Bahrain, Yemen
- Module 5: Egypt, Sudan
- Module 6: Iran, Iraq, Syria
- Module 7: Lebanon, Jordan and Palestine
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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