Medical Devices Registration and  Regulatory Consultation in Saudi Arabia.


The Kingdom of Saudi Arabia has been rated in the top 20 most economically competitive countries in the world. With the government investment plans in the Health Care sector & stable economy, Saudi Arabia is always of key interest for international Medical Device Manufacturers planning to enter new markets.
Bio-Standards offers regulatory consultation services to assist our clients comprehend the intent and the sanctions of the Saudi Food & Drug Authority (SFDA) regulations. We can support with getting the appropriate Medical Device classification, approval for Research and Educational purpose devices, and approval for Demonstration and Training purpose devices from the SFDA. As part to our consultation services, Bio-Standards provides clients with structured & reliable Medical Device Market Research Reports of Saudi Arabia. We can assist with the process of gathering, analyzing and interpreting information about Medical Device market, about a product or service to be offered for sale in that market, and about the past, present and potential customers for your Medical Devices, research into the characteristics, spending habits, location and needs of your business’s target market, the industry as a whole, and the particular competitors you face. Our team is always ready to assist local and foreign parties looking for guidance and support into the Medical Device Sector of Saudi Arabia.

Medical Device Registration in Saudi Arabia is based on companies already having approval in one of the following reference markets: Australia, Canada, Europe, Japan, and/or the USA; and registration in one of these markets is mandatory in order to register in Saudi Arabia.

Per  SFDA process, All medical devices & IVDs intended to be marketed in the Saudi Arabia should have a valid Medical Device Marketing Authorization (MDMA) as per the following enforcement dates.

Our services are based on medical devices regulation in Saudi Arabia in order to ensure your compliance with SFDA.