Renewal of Registration of a Manufacturer of Medical Products

about-the-service

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

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

• 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

required-documents

• Documents for registering a (conventional medicines/biological medicines/GSL products/natural source medicines) manufacturer:
• 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 the country of origin (Attested by the UAE Embassy in the country of origin).
• Legalized valid manufacturing license issued by the competent authority in the country of origin. (Attested true by the UAE Embassy in the 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.
• Documents 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 Emirates Drug Establishment
• Valid legalized ISO 13485 certificate issued by the competent authority in country of origin
• Required legalized valid business licenses/manufacturing license issued by the competent authority in the country of origin (attested true by the UAE Embassy in the country of origin)
• List of the medical products manufactured and/or assembled by the site
• Detailed company profile

faqs

• What is the fee for renewing the registration of a medical products' manufacturer service
• Application fees: AED 100
• Renew Registration of a medical products' manufacturer: AED 10,000