Acting as the local Authorized Representative to manage regulatory communication, submissions, and compliance obligations with SFDA.
Additionally, obtaining and supporting Medical Device Establishment Licenses (MDEL) for local manufacturers and clients operating in Saudi Arabia.

Preparation, submission, and follow‑up of MDMA applications to enable legal marketing of medical devices in KSA.

Comprehensive review of the full Technical File (TF) As external approvals it is not mandatory to initiate SFDA registration, to ensure accurate regulatory alignment.

Regulatory classification support to determine the correct registration pathway.
In cases of uncertainty, we assist in confirming whether the product falls within SFDA scope, outside SFDA scope, or under another regulatory category, ensuring proper regulatory direction before submission.

Ongoing post‑market support, including vigilance reporting and post‑market follow‑up in accordance with SFDA requirements.

We assist you in maneuvering through Egypt's complex regulatory processes through our EDA-licensed Scientific Office as a reliable partner to all our clients.

From the submissions of assembled registrational dossiers and approvals of submissions to the post-marketing and vigilance activities of manufacturers, we provide full support, even in the representation of manufacturers.

We take care of communications with the EDA concerning the changes in any products or manufacturers, manage responses to requests for further clarification, and make sure the all-advertising activities are fully sanctioned.

We also assist in the approvals for the release of shipment, providing easy compliance and access to the Egypt market for manufacturers.

We provide end-to-end regulatory support in the UAE to ensure your products meet all local necessities. Our services include product registration with the Ministry of Health (MOH).

Product listing with Abu Dhabi Health Authority (HAAD) and Dubai Health Authority (DHA), as well as registering medical products with the Emirates Authority for Standardization and Metrology (ESMA).

We also manage all post-marketing duties, guaranteeing full compliance and a smooth path to market across the Emirates.

Our support ensures that your products meet all regulatory requirements, achieving compliance and a hassle-free launch across the UAE market.