This services allows the registration of medical equipment with the purpose of importing and trading them in UAE.

• 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.

• 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.