WHEREAS, it is necessary to prevent and take precautionary measures before greater scale of public health damage due to corona virus which is announced as a pandemic by the WHO and spreading all over the world including Ethiopia;

WHEREAS, it is necessary to issue expedited authorization for manufacture, import or sale of medical products to deal with the existing significant risk of COVID-19;

WHEREAS, it is necessary to provide a clear guidance to manufacturers and importers to organize and submit the required scientific documented evidence in a timely manner for the sale or importation of medical devices that are manufactured, sold or represented for use in relation to COVID-19;

WHEREAS, it is necessary to protect the public from unsafe and poor quality medical products which can increase risk of spread of infectious agents;

WHEREAS, it is necessary to take appropriate administrative measures against violations of this directive and other relevant laws;

WHEREAS, it is necessary to ensure that medical products that are integral to the diagnosis, protection or prevention of COVID-19 can be quickly authorized for sale or importation in order to address the urgent public health need;

NOW, THEREFORE, this directive is issued in accordance with Article 71 (2) of the Food and Medicine Administration Proclamation No 1112/2019.