Navigate MENA Medical Device Registration with Expert Guidance
Expanding your medical device business in the Middle East and North Africa (MENA) region requires compliance with various regulatory authorities, including the Saudi Food & Drug Authority (SFDA), United Arab Emirates Ministry of Health (MOHAP), Egyptian Drug Authority (EDA), and others. Our consultancy services streamline the regulatory process, ensuring smooth market entry across the region.
Step-by-Step MENA Medical Device Registration Process
Device Classification & Regulatory Pathway Identification
- Determine device classification (Class I, II, III, or IV) based on country-specific regulations.
- Identify applicable registration pathways (SFDA MDMA, UAE ECAS, Egypt EDA, etc.).
- Develop a tailored regulatory strategy for market entry.
Appointing a Local Authorized Representative
- Assist in appointing a local representative/distributor where required.
- Ensure compliance with local agent responsibilities and regulatory communication.
Technical File Preparation & Submission
- Compile documentation including device description, labeling, IFU, and risk assessment.
- Ensure compliance with international standards (ISO 13485, MDSAP, FDA, or CE Marking as applicable).
- Submit dossiers to relevant MENA regulatory authorities for review.
Regulatory Review & Approval Process
- Coordinate with authorities for document verification and technical assessment.
- Address regulatory inquiries and provide additional data when requested.
- Obtain the necessary approvals, licenses, or certifications for market entry.
Post-Market Compliance & Vigilance Requirements
- Ensure adherence to post-market surveillance (PMS) regulations.
- Manage adverse event reporting, recalls, and corrective actions.
- Support in renewals, modifications, and compliance audits.
GULF / MIDDLE EAST COUNTRIES: Bahrain, Kuwait, Saudi Arabia, Syria, Qatar, Dubai, Oman.
