Consultancy Services for Local Medical device manufacturers

All entities who want to engage in the manufacture of products that fulfil the definition of medical devices (including in vitro diagnostics) must be issued Certificate of Competence (CoC) from Ethiopian Food and Drug Authority (EFDA) before manufacturing and marketing the devices. The definitions for manufacturer and medical devices as provided in the Proclamation No- 1112/2019 are consistent with the IMDRF’s definitions.
Once such entities are issued the CoC by the EFDA’s department of Inspection and Enforcement to proceed production of devices stated in the CoC’s scope, these entities/manufacturers need to continue to show their efforts to comply with the Authority’s requirements of Quality Management System (QMS) required from medical device manufacturers that is of course similar with the international standard- ISO 13485: 2016. Please Click Here to know what the standard is about, how to comply with it and benefits from its compliance.

In the CoC issuance process as per the Authority’s all relevant regulatory requirements, Ethiobiomedical has been supporting and will keep supporting individuals or companies who are interested in the medical device manufacturing business in the country. It is not just documentation requirements that are covered, but – environmental impact assessment, facility design review, workflow setup and other related tasks needed by our clients. Our comprehensive consultancy services will help our clients, in which it will- save time and effort, minimize errors in legal and administrative setup, faster route to market, low involvement in technical or bureaucratic steps.