The necessary conformity assessment elements are:
a) a quality management system (QMS)
b) a system for post-market surveillance
c) technical documentation
d) a declaration of conformity
e) the registration of manufacturers and their medical devices by the authority

EFDA’s requirement for technical documentation follows the IMDRF’s Submission Table of Contents for Marketing Authorization of Medical devices and IVD Medical devices. The
Authority has developed two registration requirements guidelines for these groups of devices (IVD and Non-IVD) and is implementing these requirements.

Guidelines for Medical Device Labeling

Guidelines for Authorization of Medical Device Clinical Investigation

9.2.4 Service Fee for Registration of Medical device
According to the current version of the regulation, the payable fees should be the following: 
New Application Screening – 350 birrs;
New Application Evaluation – 1300 birr;
Laboratory Test – 200 US dollars;
Renewal Application Evaluation – 870 birrs;
Major Variation Application Evaluation – 870 birrs;
Minor Variation Application Evaluation – 650 birrs;
Agency Agreement – 50 US dollars. 

As an evidence, the list shall be supported by copies of Marketing Authorization, free sale certificates or any other supporting certificates issued by the National Regulatory Authorities
of the listed Countries.

Guideline for Post-market surveillance of Medical Devices

Death of the patient, end-user or any other person occurred
(e.g. Balloon catheter failed to deflate and patient death resulted)
 Serious deterioration in health of the patient, end-user or any other person occurred , like:
 Life threatening
 Permanent damage to a body structure
 Permanent impairment to a body function
 Extended Hospitalization
 Condition which necessitates medical or surgical intervention.
 No death/ serious injury to patient, but death/ serious injury might occur if AE happens again
(e.g. Failure code in infusion pump caused pump to stop infusion; nurse, who was present, rectified device malfunction)

Guidelines for Medical Device Recall

Any applicant requesting special import permit (pre-import permit) of medicine and medical device should apply through the authority's Electronic Regulatory Information System (eRIS).