Webinar: Regulatory Changes for Medical Devices in Ethiopia
In this month's webinar, Priya Bhutani introduces important updates on medical device regulations in Ethiopia, a topic that has not been covered before. The session features expert Fasika Mechete Alemu, who shares insights into the regulatory framework and recent changes.
The webinar outlines the classification of medical devices in Ethiopia, which aligns with international standards, categorizing them into classes A through D for medical devices and 1 to 4 for in vitro diagnostics (IVDs). Notably, the approval process for medical devices previously took a long time, but recent updates aim to streamline this, particularly for low-risk devices, which can now receive immediate registration under a new guideline introduced in April 2021.
Key points include:
Classification of Devices: Medical devices are classified based on risk, with low-risk devices enjoying a simplified registration process.
Approval Time: For devices approved by recognized international regulatory authorities, the registration time has been reduced to less than three months if documentation is complete.
New Guidelines: Recent guidelines separate the registration processes for medical devices and IVDs, enhancing clarity and efficiency.
Post-Approval Change Notifications: A new guideline categorizes changes to approved devices into critical, major, and minor changes, allowing for more proportional regulatory responses based on the nature of the change.
The session encourages attendees to submit questions throughout the presentation, promising to address them either during the Q&A or via email afterward. This proactive approach aims to enhance understanding and compliance for manufacturers in Ethiopia's evolving regulatory landscape.