The Saudi Regulation for Medical Devices and IVDs

The aims and learning outcomes of this course are:

• To understand the Saudi Arabian regulations for Medical Devices and IVDs.
• To appreciate the EU and global requirements of Medical Devices and IVDs.

Following completion of this course, participants should:

• Understand the Saudi Regulation for Medical Devices and IVDs.
• Be able to actively participate in preparing documentation for technical files.
• All participants should have a working knowledge of the requirements.

This seven module course is held live in an online lecture theatre and delivered with a PowerPoint presentation.  All participants will fully engage with the lecturer through both group and individual exercises and direct participation throughout the course.  There are exercises included in order to ensure the course contents are fully understood and the opportunity is always available for participants to ask questions.

OC017 explores the Saudi regulation and is broken down into 7 modules.

1. Introduction to the law.
2. Classification and subcontractors.
3. Essential Principles, verification and validation.
4. Risk.
5. Clinical Evaluation.
6. The Declaration of Conformity and Post-Market Activities.
7. Vigilance and technical file construction.