MEDICAL DEVICE REGISTRATION AND APPROVAL IN Saudi Arabia

MEDICAL DEVICE REGISTRATION AND APPROVAL IN Saudi Arabia

General country-specific regulatory information is provided on this page for medical device registration and approval in Saudi Arabia
Last update: January 2024

Medical Device Regulations and Classification in Saudi Arabia

REGULATORY AUTHORITY: The Saudi Food and Drug Association (SFDA) is responsible to regulate medical devices in Saudi Arabia

CLASSIFICATION SYSTEM: Saudi Arabia has a classification system that consists of four classes: A, B, C, and D. Generally, they consist of the EU classification system (I, IIa, IIb, III).

TIMEFRAME: 35 working days.

SPECIAL REQUIREMENTS:

Local testing is required for devices that are listed in Annex 1 of MDS G29.  In most cases, however, the application is waived from local testing.

LOCAL FEES (New Application):

Medical Device Marketing Authorization (MDMA):

Class I/General IVDs/Exempt IVD (TGA) – USD 4000

Class II/IIa/Self-test IVD/Listable IVD – USD 5067

Class IIb/Class III (CA, PAL)/Annex II List B (IVD) – USD 5600

Class III/Class IV/AIMD/Annex II List A (IVD)/Registrable IVD – USD 6133

Medical Device Listing in Medical Device National Registry (MDNR): USD 135

*Please note that these are fees currently enforced. However, as soon as the new regulation is enforced in January 2021, the new fee schedule will be implemented.

LOCAL FEES (Manufacturer):

Establishment License

Prior to place medical devices on the market, any organization dealing with the importation and/or distribution shall apply for the Medical Device Establishment License (MDEL). The fees required varies (from USD 4000 to 9350) depending on type of medical devices they are dealing with.

License for Authorized Representative (AR)

The AR shall have separate licenses for each manufacturer it represents within the KSA. The fee required is fixed (around 1300 USD per year).

LICENSE VALIDITY: Marketing licenses are valid for three years.

LICENSE TRANSFER:  License transfers are possible in Saudi Arabia.

AUTHORIZED REPRESENTATIVE: A local authorized representative is required.

ADDITIONAL INFORMATION: Before initiating a product registration process, it is required to apply for an Authorized Representative License (ARL), which will officially approve the representation agreement in KSA.

JUST SAY WHEN!

Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

Ready to Get Started?