Registering 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 the medical devices that helps 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 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

Cost analysis :

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

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 dealer more easily.

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

If you are looking for an Authorized Representative company or local distributors for your medical devices, feel free to contact us (http://cleverexport.com/contact-us/).

Pic: Jesse Orrico_Unsplash.com