You manufacture. We manage the regulatory journey. We represent manufacturers before SFDA and follow regulatory obligations and official communication to support continued compliance in the Saudi market.
Dream Works Trading Establishment provides specialized medical-device regulatory consulting - from regulatory pathway assessment and dossier preparation to registration follow-up and regulatory communication. Our focus is to simplify the Saudi market-entry journey for overseas manufacturers.
We coordinate requirements, documentation, responses and follow-up to support compliant market access in Saudi Arabia.
Determining the device category and its regulatory requirements as a first step before anything else.
Reviewing the nature of the product and identifying the most suitable registration pathway.
Organizing and reviewing application data before submission to SFDA's platform.
Examining the device's technical file and flagging any gaps before submission.
Following up on the marketing authorization and renewing it as it approaches expiry.
Responding to SFDA queries and following the application through to a decision.
Structured dossier management - from classification to approval.
We review before submission to reduce deficiencies and delays.
Licensed consultancy office for medical device regulation.
One coordinated contact from dossier start through follow-up.
Services designed to simplify Saudi market entry.
Follow-up on deficiencies, updates and relevant renewals.
Issued to Dream Works Trading Establishment - valid from 27/11/2025 to 26/11/2030. Consultation scope: Consulting Services Activities in the Field of Medical Device Regulation.
Our goal is not only to submit an application, but to build a clear regulatory pathway for the manufacturer in Saudi Arabia. We help structure documentation, prioritize requirements, manage follow-up and support continued compliance after registration - making regulatory communication clearer and more efficient.
Preparation and review of registration requirements and data.
Learn more →Support for SABER applications and product conformity requirements.
Learn more →Review of certificates, reports, invoices and product information.
Learn more →Readiness assessment, gap identification and clear action planning.
Learn more →Riyadh, Kingdom of Saudi Arabia · 00966540000260 · info@works.com.sa
