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Who we serve

Overseas manufacturers.

Selling medical devices in Saudi Arabia from abroad starts with an SFDA-licensed Authorized Representative. IREG fulfils this role and manages the associated regulatory requirements.

Already registered in Saudi Arabia

Changing your AR or renewing a certificate?

Transfer your AR to IREG

Already on the Saudi market with another AR? We transfer your MDMA certificates from your current AR to IREG, at your request.

Discuss a transfer

Renew in good time

Contact us well before your AR agreement or MDMA certificate expires, so your renewal can be prepared and submitted before the expiry date.

Plan your renewal

Representation & registration

  1. 01
    AR agreementReviewing and submitting the Authorized Representative agreement to the SFDA.
  2. 02
    Registration adviceAdvice on medical device registration with the SFDA.
  3. 03
    TFA preparationWorking with your regulatory affairs team on technical file assessment requirements.
  4. 04
    Technical file reviewRevising your technical file documentation and giving feedback where needed.
  5. 05
    MDMA submissionPreparing and submitting MDMA applications to the SFDA, including the required technical documentation.
  6. 06
    Product classificationClassification requests to the SFDA to confirm whether a product falls under its supervision.
  7. 07
    Certificate transferTransferring MDMA certificates from other ARs to IREG, at your request.

Lifecycle

  1. 01
    MDMA renewalMDMA renewal and lifecycle management, with advance planning to support timely submission before certificate expiry.
  2. 02
    MDMA updateUpdating valid MDMA certificates.
  3. 03
    UDI / Saudi-DISubmitting UDI information to the Saudi-DI database for every approved product.
  4. 04
    Advertising approvalApplying for medical device advertising approval.

Post-market

  1. 01
    Vigilance & reportingRecalls, field safety corrective actions and adverse events, reported to the National Centre for Medical Device Reporting (NCMDR).

Company certificates

  1. 01
    Contractor classification certificate
  2. 02
    Local content certificate
  3. 03
    Regional headquarters certificateFor foreign companies.
For overseas manufacturers

Start your SFDA registration.

Tell us about your devices and where they stand with the SFDA. We’ll set out the AR, MDMA or transfer steps that apply.

Discuss AR and MDMA registrationinfo@i-regulations.com
+966 53 530 0129