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WATCH NOW: Medical Device Registration Requirements in Saudi Arabia

Recorded on January 22, 2019

The Kingdom of Saudi Arabia (KSA) is the largest market in the GCC region and relies on international imports for roughly 98% of all medical devices. The Saudi Food & Drug Authority (SFDA) was established in 2003 and is responsible for regulating food and drugs, as well as medical devices and IVDs. An SFDA device registration is based on an existing approval in Australia, Canada, EU, Japan, or the USA. However, SFDA officials are meticulous in their review of medical device submissions, particularly regarding consistency in the required documentation.

In this free webinar, we will examine current medical device registration requirements in Saudi Arabia, recent regulatory changes, and best practices.

WHAT YOU WILL LEARN:

  • In-country representation requirements
  • Regulatory framework overview – grouping and MDMA submission types
  • Registration routes – MDMA vs. MDNR
  • Submission requirements
  • Fees
  • Post-approval requirements

ABOUT THE PRESENTER:

Brittany Dunning, MBA, CPHQ is a regulatory research consultant at Emergo and works with device companies seeking market access in Saudi Arabia. She holds a Master of Business Administration from the University of Louisiana at Lafayette. Prior to joining Emergo in 2017, Brittany worked in healthcare quality.