Webinar: The gateway to the Saudi Medtech market

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. It is not possible to become established in the market without either a registered office in Saudi Arabia or an authorized local agent. The latter must register with the SFDA and can then submit medical devices for approval. The authorized representative may be the importer, distributor or an independent agency.

Webinar: Tips, regulatory updates and guidelinesThe rapidly changing nature of the Saudi medtech market continues to create new opportunities and challenges. 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.