About Ethiobiomedical

“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 has a team of multidisciplinary competent experts with more than 10 years of demonstrated experience in medical devices regulation who are committed to support manufacturers of medical devices and IVDs to register their devices with Ethiopian Food and Drug Authority (EFDA).

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 help manufacturers in reviewing their documents produced with the aim of complying with the EFDA's regulatory requirements of Medical devices Good Manufacturing Practice which is in alignment with the ISO 13485- Medical device 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.