Guidelines for Classification of Medical devices other than In Vitro diagnostic medical devices
In order to permit the marketability of medical devices in the Country, the Ethiopian Food and Drug Authority (EFDA) exercises different regulatory controls from their manufacture to disposal. These regulatory controls are divided into different sequential regulatory functions/pathways- premarket product dossier assessment, Quality Management System Inspection, Lab Analysis (if applicable), Distribution control (including import control), and Post-marketing Surveillance. At each control function, the Authority applies a risk-based approach to achieve its goal effectively in a timely manner. One of such approaches is to categorize the products themselves into different risk classes.
The Authority classifies Medical devices other than In Vitro Diagnostic (Non-IVDs) into Class I, II, III, and IV. Class I represents devices with lowest risk level and Class IV represents devices with the highest risk level. The IVD Medical devices are classified on their own as Class A, B, C, and D in which Class A represents the lowest risk and Class D represents the highest risk level. IVD classification is not included in this article and it is also not in the published guideline (as it has its own separate guideline).
The classification of Non-IVDs are made based on rules that are included in the guideline. The classification rules are based on various criteria, such as the duration of contact with the patient, the degree of invasiveness and the part of the body affected by the use of the device, intended purpose, and duration. Transient devices are normally intended to be used continuously for less than 60minutes; short-term devices are normally not more than 30 days; and, long-term devices are normally devices to be used continuously for more than 30 days.