Saudi Arabia| Regulatory Market Profile

Saudi Arabia medical device market profile

Updated January 1, 2023

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Saudi Arabia Medical Device Regulations & Guidance

SFDA Medical Device Classifications

Medical Devices

Saudi Arabia classifies medical devices into four classes and uses the same 22 classification rules found in the MDR:

Class A - Low risk (MDR Class I).

Class B - Low to medium risk (MDR class IIa).

Class A - Sterile or Measuring function - Low to medium risk (MDR Class I - sterile/measuring)

Class C - Medium to high risk (MDR class IIb).

Class A - Reusable surgical instruments - Low to medium risk (MDR Class I - reusable)

Class D - High risk (MDR class III).

In Vitro Diagnostic Devices

IVD classifications are similar to those defined in the EU IVDR:

Class A - Lowest risk. Examples include specimen receptacles and buffer solutions.

Class C - IVDs used for detecting an infectious agent that does not have a high risk of propogation.

Class B - IVDs for self-testing with lower risk to patients.

Class D - IVDs that detect or are exposed to life-threatening transmissible agents or or transmissible agents and infectious diseases with a high risk of propagation.

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Guidance on medical device classification (MDS-G008)

Medical Device Market Requirements in Saudi Arabia

The SFDA requires a Medical Device National Registry (MDNR) number before a device is placed on the market.

Note that proof of certification in a GHTF founding country is no longer sufficient on its own to obtain market entrance.

2 market entrance paths:

Class A devices can be registered through a simplified listing procedure (not including sterile, measuring, or reusable surgical devices).

All other devices need to obtain a Medical Device Marketing Authorization (MDMA) by demonstrating conformance with essential principles of safety and performance as defined in the Medical Device Interim Regulation. Authorizations are valid for 3 years.

MDMA approval:

For devices that are already registered in another country, MDMA approval can be granted with proof of marketing authorization in the "base" country, along with demonstration of a QMS and compliance with all SFDA regulations. This includes a declaration of conformity to Annex 11 of MD-G5 and confirmation that the device can fulfill its intended purpose under the specific climate conditions in Saudi Arabia.

MDMA can also be granted on proof of compliance with the "essential principles of safety and performance." In this case the SFDA will review technical documentation including, but not limited to, risk management documentation, essential principles checklist, PMS plan, PSUR or PMS report, QMS, and proof that the device complies with all applicable SFDA regulations.

All documents must be submitted in English.

Document assessment is done by Conformity Assessment Bodies (CAB), similar to EU notified bodies.

The Saber electronic platform is used to register products and certificates of conformity, as well as access Conformity Assessment Bodies.

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Saber electronic platform

Saudi Arabia Post-Market Requirements for Medical Devices

Post-Market Surveillance

The Authorized Representative (AR) is responsible for the mandatory reporting of incidents by submitting them to the National Centre for Medical Device Reporting (NCMDR).  

Reporting requirements are as follows:

Serious public health threat - 2 days

Death or sever deterioration of health - 10 days

Other incidents - 30 days

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Requirements for Post-Market Surveillance of Medical Devices

Saudi Arabia UDI Requirements

Saudi Arabia currently supports voluntary UDI registration.

Required compliance for both UDI labeling and database registration are as follows:

Class D (high risk) - Sept. 1, 2023

Class B & C (medium risk) - Sept. 1, 2023

Class A (low risk) - Sept. 1, 2024

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SFDA requirements for UDI for medical devices

Standards and Essential Requirements in Saudi Arabia

SFDA "essential principles" are listed in Annex 1 of MDS-G5,