Registration of a Medical Equipment
About this service
Service process
Login to the MoHAP website or smart app using the UAE PASS
Submit the request through the electronic service and complete the payment to meet all conditions
The competent technical committees will deliberate the registration of products and recommendations shall be submitted to the competent ministerial committee
Letters shall be addressed to the concerned companies stating the committee's decisions
The customer shall follow up with the Analysis Section of at the Drug Department
The company should complete the requirements and submit them via electronic service
The relevant technical and ministerial committees will re-deliberate the registration of products that have been deferred in advance as soon as companies complete the requirements
The certificates of registration of products that have been approved for registration will be issued, provided all conditions and requirements are fulfilled. Registration certificates are valid for five years effective the date of committee's approval
The pharmaceutical certificates (for locally manufactured pharmaceutical products) will be issued and be valid for one year effective the date of issuance
Required documents
Filling out the application form of registration completely and to be signed and stamped by company.
A copy of valid registration certificate of the factory.
A valid certificate of free sale/ registration issued by the competent authorities in the country of origin certified by the Embassy of the United Arab Emirates.
A copy of the product agency contract signed between the company and the agent.
Certificate of quality conformity/ marketing authorization, such as EC (European Conformity), 510 K (Premarket Notification), PMA (Parts Manufacturer Approval) as per the classification of the equipment, i.e. Class I, II, III, IV.
Post-marketing monitoring requirements.
Product's information, including: description, formulation, types, sizes, models, accessories, usages, side effects, contradictions, warnings, precautions, usage guidelines, photos of packaging covers, brochures and usage manuals.
Provide laboratory requirements and analysis, as well as pricing for certain medical equipment.
Providing one samples, certificate of analysis (as per equipment type), external and internal covers and brochures.
Acknowledgement of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC(European Conformity)-Declaration of Conformity)
Safety and efficacy data (for products classified as Class III, IV).
Special requirements: Certificate of conformity to equipment manufactured from animal products.
Conditions and requirements
Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.
The marketing office or medical warehouse must be licensed by the Ministry of Health and have a valid license.
Service completion duration
45 working days
Service fees
Application: 100 AED
Registration of a medical device: 5,000 AED
SDGs goals
Service locations
- Mohab Website
- MOHAP Smart Application
Payment channels
- E-payment
Target audience
Medical warehouses
Local pharmaceutical manufacturers
Marketing offices
Service category
Sub service category
Factories & companies services
Main service
Medical, Pharmaceutical and Drug Licencing and Registration
Service code
110-04-013-000
Service classification
- Government to business
Service type
Transactional
Sub service type
Variation
Number of transactions
0
Notes
Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.
This service accepts documents authenticated with the UAE PASS Digital Seal.
Service completion duration
45 working days
Service fees
Application: 100 AED
Registration of a medical device: 5,000 AED
Social media share
If you like the content you can share it via