English
We are your trusted partner for SFDA medical device registration and regulatory support in Saudi Arabia. Our end-to-end services cover every step of the process—from product classification and documentation preparation to licensing, authorized representative management, and compliance guidance. We ensure your medical devices meet all SFDA requirements, obtain timely approvals, and are fully market-ready, helping you navigate the regulatory landscape with confidence and ease.
We have extensive experience in our field, so we can provide you with distinguished services.
As specialists in registering medical devices with the SFDA,we will assist you in registering your medical devices. Our team will review your technical documentation, product data, ensures compliance with Authority's standards, and guides you through every step of the approval process for smooth and efficient market entry.
We help you appoint a licensed Authorized Representative in Saudi Arabia for the registration and marketing of your medical devices. Our team guides you through the process to obtain the Authorized Representative license from SFDA, ensuring full regulatory compliance and seamless market access.
We assist companies in obtaining a Medical Device Establishment License (MDEL) in Saudi Arabia, enabling them to legally import, distribute, and manufacture medical devices in full compliance with regulatory requirements.
We help businesses establish and register warehouses for medical devices, ensuring full compliance with regulatory requirements and smooth operations.
We assist manufacturers to successfully transfer their local Authorized Representative in Saudi Arabia, including the seamless transfer of associated product licenses (MDMA), ensuring regulatory compliance and continuity of market access.
We facilitate the issuance of ISO certificates from IAF-accredited certification bodies and provide tailored ISO 13485 quality manual checklists to simplify establishment registration and ensure smooth regulatory compliance.
