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REGISTERING MEDICAL DEVICES IN SAUDI ARABIA

How to register medical devices in Saudi Arabia?

When it comes to selling medical devices, registering your products is a must. The Kingdom of Saudi Arabia has implemented rules for medical devices that help regulating the sector and protecting end-users and patients.

The governmental institution in charge of this important task is the Saudi Food and Drug Administration (SFDA). If you want to sell your products in the country, the SFDA will require that you have Medical Device Marketing Authorization (MDMA) certificates for your products. Those MDMA certificates are obtained through an application made by your local Authorized Representative (AR).

An Authorized Representative is a local company registered in a Saudi Chamber of Commerce and with a permanent address in the country. It will be your representative before the institution and it will:

  • Submit your applications for MDMA approval & certificates
  • Be responsible for all communication between the manufacturer and SFDA
  • Renew your MDMA certificates
  • Update all information inside the SFDA system
  • Inform SFDA for product recalls not affecting the Saudi market
  • Coordinate all product recalls affecting the Saudi market / provide to them the proofs for product improvement or case resolution after product recalls
  • Provide all required document or information asked by the SFDA

COSTS ANALYSIS

Those costs are approximate and indicative, they might change according to Saudi laws and according which AR company you select

table cost SFDA registration & AR fees

ADDITIONAL TIP

An Authorized Representative can be a local dealer or an external regulatory company. If you want to be fully independent, we strongly recommend you giving the AR role to an external company specialized in Regulatory Affairs. If you have tensions with your dealer in the future, you will not be trapped, and you can change the dealer more easily.

For more information please visit the official website of the SFDA: https://mdma.sfda.gov.sa/Default.aspx

Pic: Jesse Orrico_Unsplash.com

4 replies on “REGISTERING MEDICAL DEVICES IN SAUDI ARABIA”

Hello, we currently have a MDMA for a product we sell in your country. If we sell this device to another company what must I do? Are they responsible for filling out the paperwork with their AR? Can you please tell me the process? Thank you very much.
Kind regards,
Deborah Mackmin

Dear Deborah,

Thank you for reaching out.
It’s Nicolas, owner of this blog and the man in the video. I have sent to you a private email to your email address. It would be better to speak over the phone about your situation as I went through a similar one.
If you can’t see my email in your inbox, you can send to me your phone number on the contact form of this blog and I’ll call you back.

Best regards,
Nicolas BERNARD-MASSON

Can we change a medical device to a drug dossier with transition from regional license holder (3rd party client as distributor) to a local representative in KSA?

Dear Amira,

Sorry, I am a former export sales manager but not specialized in KSA MDMA registration in details. I will send you by email the info of my contact. He might help you.

Best regards,

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