The Saudi medtech market is estimated to be worth two billion US dollars and is growing by about ten percent annually. For medical devices and in vitro diagnostics in particular, this opens up interesting and attractive opportunities – and challenges. The market is regulated; Saudi Arabia recently introduced the Medical Device Interim Regulations as part of its Vision 2030. In order to enter the market, all manufacturers, service providers, dealers and distributors of medical devices require market approval from the Saudi Food & Drug Authority (SFDA). They must also have a QM system that is compliant with "ISO 13485:2016".
Opportunities and challenges
The constant regulatory updates and guidelines of the Saudi Modernization Program and Vision 2030 are not without their problems. Suppliers and manufacturers face various challenges in the areas of regulation or certification. They also face obstacles in customs clearance and payment collection.
Webinar: Tips, regulatory updates and guidelines
Nevertheless, the rapidly changing nature of the Saudi medtech market continues to create new opportunities as well. We help you to maintain an overview. In our webinar, we'll bring you up to speed on regulatory updates and guidance in the area of medical devices, give you tips for medical device registration and show you what new business opportunities "Vision 2030" brings with it.
- Welcome and Introduction by Ruedi Büchi, Senior Consultant Middle East, Switzerland Global Enterprise
- Overview about the Saudi medtech sector including trends by Meshary A. Alghobain and Mr Mohannad Alatr Business Development Analyst Ministry of Investment Saudi Arabia (MISA)
- Regulations & registration of Medical Devices by Eng. Sameer A. Al-Hamdan, Head of products Registration Support Saudi Food & Drug Authority (SFDA)
- Tips to consider when registering your medical devices by Eng. Omar M. AL-Sohime, Products Registration Support Expert Saudi Food & Drug Authority (SFDA)
- Q & A