Providing Consultation Services for overseas manufacturers with regard to Medical Devices Regulations in Lebanon. Assisting overseas manufacturer with registration of Implantable Devices and Para-Pharmaceutical Products with MoPH (Ministry of Public Health). Assisting local companies with registering their Medical devices with MoPH. Working closely with local companies for Post-Marketing requirements.
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)