United Arab Emirates
- Regulatory Authority:
Ministry of Health and Prevention (MoHAP)
- Language of labeling and documentation:
Arabic, English
- Authorized Representative:
UAE resident
The following services are available in the UAE:
Classification of medical devices in the UAE
The process in the UAE begins with the classification procedure. This process determines the need for registration with the purpose of implementation to the UAE.
- Regulatory Authority:
Ministry of Health and Prevention (MoHAP)
- Legislations:
MoHAP Guidelines for Product Classification
- Language of labeling and documentation:
Arabic, English
- Period of medical device classification:
15 working days
- Validity period of the letter:
3 years
A brief algorithm for classification of medical devices in UAE:
Registration in the system of electronic services, obtaining personal access to the electronic system
Registration of medical devices in UAE
- Regulatory Authority:
Ministry of Health and Prevention (MoHAP)
- Legislation:
Guidelines for Registration of Medical Devices in the UAE
- Language of labeling and documentation:
Arabic, English
- Registration period:
45 working days
- Authorized Representative:
UAE resident
A brief algorithm for registration of medical devices in UAE:
Registration in the system of electronic services, obtaining personal access to the electronic system
Next, the competent technical committees will review the product registration and then the recommendations will be forwarded to the competent ministerial committee
The relevant technical and ministerial committees will reconsider the product registration after the company fulfills all requirements
Классификация медицинских изделий
Процесс в ОАЭ начинается с процедуры классификации. Данный процесс позволяет определить необходимость регистрации для дальнейшей реализации в ОАЭ.
- Регулирующий орган:
Министерство здравоохранения и профилактики (MoHAP)
- Постановление
Руководство MoHAP по классификации продукта
- Язык
Английский и арабский
- Срок процедуры классификации:
15 рабочих дней
- Срок действия письма:
3 года
Краткий алгоритм классификации медицинских изделий ОАЭ:
Классификация медицинских изделий
- Регулирующий орган:
Министерство здравоохранения и профилактики (MoHAP)
- Постановление
Руководство по регистрации медицинских изделий в ОАЭ
- Язык
Английский и арабский
- Срок процедуры классификации:
45 рабочих дней
- Уполномоченный представитель:
Резидент ОАЭ