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Saudi Regulation for Medical Devices and IVDs

This course covers the Saudi Regulation for Medical Devices and IVDs. By the end of this course, participants will have a strong foundational knowledge of Saudi Arabian regulations.

Course Details

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 course is held over three or four days, depending on whether a certificated examination is required at the end of the course. Participants will fully engage with the lecturer through group and individual exercises.  There are plenty of opportunities to ask questions and the course can be fully tailored to the company’s products and internal structure. 

This course 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.