Saudi Arabia Approval for Medical Devices

Selling a medical device in Saudi Arabia requires appointing a Saudi authorized representative to act behalf you inside Saudi Arabia with the Saudi Food and Drug Authority (SFDA). and registration with the country’s medical device market regulator, US, Canada, Europe, Japan or Australia before registering with the SFDA

The Saudi FDA medical device approval process:

(GHTF Markets Approval )
The medical device must be approved for sale in one of the founding Global Harmonization Task Force (GHTF)* markets: US, Canada, Europe, Japan, Australia.

(Medical Device Classification )
The classification of the medical device in your reference IMDRF market will determine the classification of your device in the Kingdom of Saudi Arabia (KSA). Classes are segmented into Low-Risk Class I, Medium Risk Class II/IIa/IIb and Higher Risk Class III/IV.

( Authorized Representative in Saudi Arabia)
Appoint a Saudi Authorized Representative to manage your medical device registration in Saudi Arabia. Your representative must be licensed with the Saudi Food and Drug Authority (SFDA).

( Authorized Representative License )
Your Saudi Authorized Representative obtains a license from the SFDA showing they will represent you in Saudi Arabia. Pay license fee.

( Medical Device Marketing Authorization (MDMA) License )
Your Saudi Authorized Representative submits the Medical Device Market Authorization (MDMA) application to SFDA on your behalf. Pay registration fee Saudi FDA Applications fee and formal review time.

Saudi FDA Authorization (MDMA) as per the following enforcement dates:

Class Type Enforcement Date
High Risk In Vitro Diagnostics 1 December 2012
Medical Devices 1 December 2012
Medium Risk In Vitro Diagnostics 1 December 2012
Medical Devices 31 December 2014
Low Risk In Vitro Diagnostics 30 June 2015
Medical Devices 31 December 2015

(Medical Device Marketing)
For Class I devices ( Low-Risk ), once the MDMA application is submitted, you may begin marketing your device in the KSA before formal approval is granted. However, this privilege is subject to revocation at the Low Risk Saudi MDMA enforcement dates. ** “enforcement dates table”.

For Class II, III, and IV devices, Saudi FDA approval is required before marketing of your device may begin and MDMA license is mandatory anymore.

( Saudi FDA Certificate)
Once your device is approved, the Saudi FDA issues you a certificate. Your KSA registration is valid for three years if your device is Class I. If you are using European CE Marking as your primary proof of GHTF compliance, your approval in Saudi Arabia will expire at the same time as your CE Marking certificate.

Notes :
1- The GHTF is now the International Medical Device Regulators Forum (IMDRF).
2- Only US Class I, Europe and Australia Class I, IIa, and Canada/Japan Class I and II may be commercialized in the KSA prior to formal approval.


No Comments

Post a Comment