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Medical Devices
Saudi Arabia
We provide comprehensive regulatory support for medical devices in Saudi Arabia in full compliance with SFDA requirements, covering the entire product lifecycle:
Authorized Representative (AR) & Medical Device Establishment License (MDEL)
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.
Medical Device Marketing Authorization (MDMA) Registration
Preparation, submission, and follow‑up of MDMA applications to enable legal marketing of medical devices in KSA.
Review of the full Technical File (TF)
Comprehensive review of the full Technical File (TF) As external approvals it is not mandatory to initiate SFDA registration, to ensure accurate regulatory alignment.
Classification Services
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.
Post‑Market Surveillance (PMS)
Ongoing post‑market support, including vigilance reporting and post‑market follow‑up in accordance with SFDA requirements.
Egypt
Legal Representation & Registration
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.
Communication & Clarifications
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.
Shipment Approvals & Market Access
We also assist in the approvals for the release of shipment, providing easy compliance and access to the Egypt market for manufacturers.
UAE
Product Registration & Listings
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).
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).
Post-Marketing Management
We also manage all post-marketing duties, guaranteeing full compliance and a smooth path to market across the Emirates.
Seamless Market Access
Our support ensures that your products meet all regulatory requirements, achieving compliance and a hassle-free launch across the UAE market.
Regulatory Affairs Consultation for the MENA Region
MRG delivers tailored regulatory affairs consultation services designed to meet the unique needs of companies operating across the MENA region. We partner with pharmaceutical, medical device, and cosmetics manufacturers to help them navigate complex regulatory landscapes and achieve smooth market entry.
Our Services
