Supporting device classification, technical file organization, and follow-up on related licenses.
We review the product and its requirements and map the pathway and gaps before any execution step.
We organize the required documents and data and review them for completeness.
We submit the application and follow up, responding to any queries until a decision is issued.
Requirements vary by device type and classification, and usually include technical files, conformity documents, manufacturer details, and safety and quality documents.
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.
Share your product or device details and we'll help you identify the next step.
