Frequently asked question:

• 1. Does the distributor need to be our Authorized Representative (AR)?
  No. Any SFDA-registered company can act as your AR. The distributor and AR can be different companies.
• 2. What documents are required for SFDA registration of medical devices?
  You need a full technical file that includes:
  • Product description
  • Design and manufacturing process
  • Safety and performance validations
  • Risk management file
  • Clinical Evaluation Report (CER)
  • Post-market surveillance plan
  • ISO-13485 certificate
  • Audit report for the same ISO
• 3. What is AR ?
  AR stands for Authorized representative, as per SFDA, any legal manufacturer outside of the kingdom, if they need to register devices with SFDA must appoint a local Authorized representative.
  (AR = Manufacturer registration)
• 4. What is MDMA ?
  MDMA stands for medical device marketing authorisation, any LM who wants to sell medical devices in Saudi arabia, first needs to apply for MDMA license once received, can only market their products in KSA.
  (MDMA = Product registration)
• 5. Who can start the registration process with the SFDA?
  Overseas manufacturers must appoint an SFDA-registered Authorized Representative (AR).
  Local manufacturers need a manufacturing license from SFDA.
• 6. When can we renew our MDMA license?
  You can apply for renewal 90 days before the license expires.
• 7. How long is the MDMA license valid?
  It is valid for 3 years and can be renewed every three years.
• 8. Can we have more than one distributor?
  Yes. There is no limit to the number of distributors after you get the MDMA license.
• 9. How does SFDA classify the risk level of medical devices?
  • How long the device is used
  • How invasive it is to the body

    SFDA uses 22 rules for medical devices and 7 rules for IVDs (MDS-G008 document).

• 10. What are the SFDA registration fees for medical devices?

  Risk Class	Fee (SAR)	Approx. USD
  Class A	SAR 15,000	≈ USD 4,000
  Class B	SAR 19,000	≈ USD 5,067
  Class C	SAR 21,000	≈ USD 5,600
  Class D	SAR 23,000	≈ USD 6,135

• 11. Can we change our AR? Will it affect our registration?
  Yes, the legal manufacturer can change or appoint a new AR. This will not affect existing registrations if no registration process is ongoing.
• 12. Can we have more than one AR?
  Yes, but not for the same product.
• 13. Is the low-risk device registration pathway still available?
  No. SFDA closed this pathway on September 27, 2022.
• 14. Who can sell the device after registration?
  Any SFDA-licensed distributor can market the product in Saudi Arabia.
• 15. Must our distributor also be our AR?
  No. You can have separate companies for AR and distributor roles.
• 16. Is CE or FDA approval required for SFDA registration?
  No. But these certificates can be provided as supporting documents.div>
• 17. Do local distributors need ISO 13485 certification?
  Yes. For Class A and B products, local distributors must have ISO 13485 certification from an SFDA- or IAF-accredited body.
• 18. How many items can be included in one MDMA certificate?
  You can register up to 50 trade names in one MDMA, but they must meet SFDA bundling rules (see Annex 15 of MDS-REQ01).