Services

Medical devices that need registration are: Medical devices to be classified as para-pharmaceuticals or “similar to drugs” by the MOH Implantable medical devices The Ministry of Health will check the composition and the class of the medical device in the country of origin to decide if the medical device in question will require registration. No […]

Submitting and obtaining Medical Device Establishment License with the Medical Device Board (MDB). Submitting and obtaining Certificate of Enlistment or Registration of Medical Devices from MDB. Working closely with MDB for Post Marketing Requirements. Assisting local companies with registering their Medical devices with MDB. Providing consultation services for overseas manufacturers, local manufacturers and importers with […]

Assemble and submit the product registration file to CAPA Submit documentation to the scientific committee for review, if needed Notifying CAPA of any changes / variations in the product or any information about the manufacturer Assisting manufacturer with their post marketing and vigilance Assist with preparing responses to additional information requests from CAPA Transferring registration […]

Registering Manufactures site for Medical Device Establishment License (MDEL) with the Saudi FDA. Registering Medical Device Marketing Authorization (MDMA) with the Saudi FDA on behalf of the manufacture. Communicating with Saudi FDA of any changes in the product or any information about the manufacturer. Assisting manufacturers with their post-marketing and vigilance reporting. Classifying products with […]

Submitting Product registration with the ministry of health (MOH) Listing of product with the health authority – Abu Dhabi (HAAD) Listing products with Dubai Health Authority (DHA) Registering all medical products, as well as fulfilling all the post-marketing requirements of Emirates standardization & Metrology for Authority (ESMA)