Registration of A Manufacturer of Medical Products

about-the-service

This service allows the registration of the manufacturing sites of medical products (human) in UAE.

service-process

• Log in using UAE PASS to start the service
• Fill out the application form
• Attach the required documents
• Pay the fees
• Submit the application
• Issue the manufacturing site registration certificate after fulfilling the conditions and requirements of the Higher Committee for Registration of Human Medicines by the company

conditions-and-requirements

• Renewal of registration must be done every 5 years.
• Manufacturing site should have a marketing authorization holder (legal manufacturer) & it should be registered with Emirates Drug Establishment
• Required documents for MAH registration:
• The application form (part 1) duly filled, signed and stamped by the responsible person in the company.
• A legalized letter issued by the company on its original letterhead, signed and stamped by the responsible person in the company, authorizing a person or a local establishment to submit the registration file on its behalf, to the Emirates Drug Establishment (attested by UAE Embassy). This person / the local establishment will be responsible to receive the registration certificate from EDE.
• Legalized company license issued by the competent authority in its country origin, showing all its licensed activities there (attested true by UAE Embassy).
• Company Profile.
• List of associated manufacturing facilities, if any.
• List of all medical products dealing with in the country of origin.
• Evidence of the company's presence in other countries, if available.
• For registration of marketing authorization holder (MAH) in UAE EDE, the applicant can submit the documents with the site registration application.

required-documents

• A legalized letter issued by the company on its original letterhead, signed and stamped by the responsible person in the company, authorizing a person or a local establishment to submit the registration file on its behalf, to the Emirates Drug Establishment (attested by UAE Embassy). This person / the local establishment will be responsible to receive the registration certificate from EDE
• Legalized Current GMP certificate issued by the competent authority in country of origin (attested by the UAE Embassy in country of origin)
• Legalized valid manufacturing license issued by the competent authority in country of origin (attested by the UAE Embassy in country of origin).
• List of medical products manufactured at the manufacturing site.
• Site Master File
• Certified copies of certificates of registration/ certificates of good manufacturing practice of the manufacturing site in other countries
• For registering a medical device manufacturing site:
• A notarized letter issued by the company on its original letterhead, signed and stamped by the responsible person in the company, authorizing a person or a local establishment to submit the registration files on their behalf, to the EDE
• Valid legalized ISO 13485 certificate issued by the competent authority in country of origin
• Require legalized valid business licenses / manufacturing license issued by the competent authority in country of origin (attested by the UAE Embassy in country of origin)
• List of the medical products manufactured and/or assembled by the site
• Detailed company profile