The SFDA requires regulatory approval of any and all medical devices that will be marketed and sold in Saudi Arabia. The SFDA classification is no different from the classification applied in the Western Hemisphere and, as such, each product registration depends on its classification.
In addition, a product registration is also dependent on two more factors:
The quality system applied at the manufacturing facility. The manufacturing facility must be licensed by the regulatory authorities of the country where the device is manufactured and sold.
The intended use of the device, personal or professional.
Generally, the SFDA applies and approves a medical device registration if the device is already approved in one of the following reference markets: Australia, Canada, Europe, Japan, and/or the USA.
All medical devices & IVDs intended to be marketed in the Saudi Arabia should have a valid Medical Device Marketing Authorization (MDMA).
As per SFDA regulations, any medical device manufacturer should appoint a Saudi-based Authorized Representative “AR”, who will only serve as your liaison with the Saudi Food & Drug Authority (SFDA). Being your Authorized Representation, MediWay Regulatory Services is well positioned to better serve your company’s interests with the SFDA, including:
Submit your medical device or IVD registration to the SFDA
Administer all registration fees
Communicate and coordinate with the SFDA on your behalf
Support device recalls or Field Safety Corrective Actions (FSCA) if needed