Food and Drug Product Registration
Preparing registration requirements and reviewing product data and documents before SFDA submission.
Consulting services in medical device regulation
We simplify the journey from understanding requirements to preparing files and following up registration procedures with a clear process and careful attention to detail.
About Us
Regulatory consulting with clear identity and precise execution.
Dream Works Trading Establishment supports businesses in registering medical products and devices by reviewing requirements, organizing documents, and identifying the right submission pathway.
Services
Regulatory and trade services that shorten the process
Medical Device Registration
Supporting device classification, technical file organization, and follow-up on related licenses.
Saber Certificates and Follow-up
Handling Saber requests and product conformity certificates with pre-submission requirement checks.
Legal Representation Services
Representing manufacturers before SFDA, following regulatory obligations, and managing official communication to support continued compliance in the Saudi market.
Conformity and Approvals
Reviewing conformity certificates, reports, invoices, and product data for regulatory alignment.
Consulting and File Preparation
Assessing product readiness, identifying gaps, and preparing a clear plan before starting.
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FAQ
Helpful information before registering a medical product or device
How can a medical product be registered in Saudi Arabia?
The process starts by identifying the product classification and requirements, then preparing and reviewing technical documents and product data before submission to the relevant authority such as SFDA when applicable.
What are the requirements for medical device registration?
Requirements vary by device type and classification, and usually include technical files, conformity documents, manufacturer details, and safety and quality documents.
Do I need a Saber certificate or conformity certificate?
Some products require a conformity certificate through Saber depending on product type and applicable technical regulations, so requirements should be reviewed before importing or selling.
How are Fasah and customs related to imported products?
Fasah and customs are related to product entry procedures, including required documents, customs tariff information, and clearance requirements at ports.
What is MDMA medical device registration?
MDMA is the Medical Devices Marketing Authorization process used to review technical documentation, device data, and regulatory requirements before a medical device may be marketed in Saudi Arabia.
What is an authorized representative license for medical devices?
An authorized representative license allows a licensed Saudi establishment to represent the manufacturer before SFDA, follow regulatory obligations, and manage official communication for medical devices.
What is a local establishment license for import and distribution?
It is a license for medical device establishments that wish to conduct import or distribution activities in Saudi Arabia, with requirements depending on the establishment type and activity.
What is a medical manufacturing facility license?
A medical manufacturing facility license is for local establishments that manufacture medical devices or supplies, and it involves reviewing the factory activity, quality requirements, and regulatory compliance.
Contact Us
Do you have a product that needs registration or assessment?
Share the product details and we will help identify the suitable requirements and next steps.
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