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

when-applying-through-the-website

• 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
• Approve the manufacturing site registration certificate

conditions-and-requirements

• The applicant must be a medical warehouse licensed by EDE and must have a valid license.
• Renewal of registration must be done every 5 years.
• Renewal of registration will be in the same fees and procedures.
• Manufacturing Site Should have a Marketing Authorization Holder (Legal Manufacturer) & it should be registered on EDE.
• 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 Drug Control Department (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 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 OR by submitting the required documents through the courier to EDE.

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 Drug Control Department (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 medicines 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 products manufactured and/or assembled by the site
• Detailed company profile