MedTalk: Saudi Arabia Medical Device Regulation and Registration Pathways for Imported Medical Devices

This training gives a clear and practical introduction to the Saudi Arabian regulations for imported medical devices. It is designed for manufacturers, distributors, authorized representatives, and regulatory professionals who want to understand how to place medical devices on the Saudi market smoothly and in compliance with Saudi Food and Drug Authority (SFDA) requirements. The focus is on real-world processes, key regulatory steps, and what is truly needed to achieve and maintain market access.

Training Content:

• Overview of the Saudi medical device regulatory framework and SFDA roles
• Classification of medical devices and IVDs under Saudi regulations
• Step-by-step explanation of the marketing authorization pathway for imported devices
• Roles and responsibilities of foreign manufacturers and Saudi Authorized Representatives
• What documentation is required and how to prepare it efficiently
• Labeling and language requirements, including Arabic expectations
• Importation and customs considerations for medical devices
• Post-market responsibilities, vigilance, and reporting obligations
• Practical tips, common mistakes, and best practices for successful registration

Die Vortragssprache ist deutsch.

Die Veranstaltung wird mit in Kooperation mit Baden-Württemberg International Gesellschaft für internationale wirtschaftliche
und wissenschaftliche Zusammenarbeit mbH stattfinden.

Der MedTalk ist für Mitaussteller des BW_i-Gemeinschaftsstands auf der WHX Dubai 2026 kostenfrei.