Whether you’re a medical device manufacturer, Authorized Representative, or a distributor in Saudi Arabia, you’re undoubtedly familiar with the stringent medical devices’ registration requirements set forth by the Saudi Food and Drug Authority (SFDA). All devices now, from low to high-risk classes, must be submitted through Medical Device Marketing Authorization (MDMA) with a full TFA procedure.
In this article, we’ll guide you through all requirements of the TFA process to ensure that your submission meets SFDA standards and garners swift approval. So, let’s dive in and get started! </br>
TFA
The TFA is a pivotal step in the registration of medical devices in Saudi Arabia, mandating the submission of exhaustive documentation to prove conformity with national regulations, essential principles, and applicable standards. This entails providing comprehensive information about the design and manufacturing facilities, including critical subcontractors, as well as device specifications. Subsequently, applicants must furnish a detailed account of the materials employed, assembly processes, sterilization methods, labelling requirements, and other manufacturing information.
Furthermore, the quality management system must be demonstrated through documents like audit reports as well as certifications. In addition, a benefit-risk analysis and strategies for post-market surveillance, including vigilance reporting procedures, must be provided.
Finally, the declaration of conformity must assert the accuracy of all relevant documentation. The submission of a complete and accurate Technical File is essential for timely SFDA approval of the medical devices.
Required Documents
Central to the TFA by the SFDA is the inclusion of vital documents that establish evidence of compliance with national regulations, standards, and guidelines. While the required documents may vary depending on the type of medical device being registered, manufacturers should provide common documents such as product specifications including intended use and indications for use, labelling information comprising instructions for use, warnings, and contraindications, manufacturing process details that encompass design drawings and production flow diagrams, and risk assessments to identify potential hazards associated with the product.
Additionally, manufacturers must provide clinical evaluation reports that demonstrate how they have assessed the safety and performance of the device in a clinical setting before releasing it to the market.
Eventually, verification/validation studies are critical, demonstrating that the device satisfies applicable regulations or standards.
A prepared set of these documents streamlines the registration process, while also ensuring compliance with SFDA’s regulatory requirements for medical devices in Saudi Arabia.
“The below diagram shows the needed documents for the registration of medical devices in Saudi Arabia. Please contact us today and ask about our ready-made-checklist for TFA, and check the feasibility of introducing your medical device into Saudi Arabia market.” Contact Now
All critical subcontractors involved in the production process must be identified.
Manufacturing processes in details; such as product design, testing protocols, and final inspection procedures.
Furthermore, as part of the TFA, technical drawings or schematics for each component may be required to illustrate how they fit into the overall design of your product.
