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Registration of A Manufacturer of Medical Products — Registration of A Manufacturer of Medical Products

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Registration of A Manufacturer of Medical Products

Service completion duration

2 to 4 weeks

Service fees

Application: AED 100

Registration of a medical products manufacturer: AED 10,000

Service Description

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 & 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

Service completion duration

2 to 4 weeks

Service fees

Application: AED 100

Registration of a medical products manufacturer: AED 10,000

Service channels

Website: www.ede.gov.ae

Support

Call Center: 80033784

Email: info@ede.gov.ae

Target audience

Pharmaceutical Drug Stores

Local Manufacturers

Marketing Offices

Payment channels

E-Payment

Resources

USER MANAGEMENT_LOGIN (14).pdf 2235KB

Registration of A Manufacturer of Medical Products.pdf 1919KB

Related Services

Issuance of Marketing Authorization for a Drug or Biopharmaceutical Product

Issuance of Marketing Authorization for a Medical Device

Issuance of Marketing Authorization for a Healthcare Product