“Ethiobiomedical” is an online platform based in Ethiopia and is designed to support medical device manufacturers to comply with Ethiopian regulatory requirements and market their products in the country. Ethiobiomedical works with other reputable and legally licensed companies to handle medical device registration process on behalf of the manufacturers, suppliers, or importers. Ethiobiomedical has a team of multidisciplinary competent experts with more than 10 years of demonstrated experience in medical devices registration.
Supports by Ethiobiomedical?
* We publish creative blogs how manufacturers and suppliers of medical devices including IVDs demonstrate their products compliance with EFDA’s regulatory requirements.
*We publish any important or critical changes or updates from the EFDA that may affect medical device manufacturers who have registered or are planning to register their products.
*We also support manufacturers on how they should compile their product dossiers to be submitted to the Authority (EFDA) for registration.
*We also work with other local importers/agents to review the product dossiers provided to them by the manufacturers for registration.
*We review the documentation produced by manufacturers for the EFDA’s regulatory requirements for Good Manufacturing Practice or Quality Management System.
Please do not hesitate to contact us for any help regarding the detail understanding of medical device regulation system and its registration processes.