The Ethiopian Food and Drug Authority (EFDA) has issued a final warning to all concerned parties to immediately cease the dissemination of unauthorized medical device advertisements across mainstream media and social media platforms.
The Authority released this directive today June 24, 2018 E.C. via its official social media channels, addressing growing concerns regarding the illicit promotion of medical products.
The Authority observed that several advertisements are being conducted in violation of established legal procedures. Furthermore, it noted that some of these unauthorized promotions involve medical devices that are strictly prohibited from being advertised on social media platforms.
Citing its mandate under Article 4 of the Food and Medicine Administration Proclamation No. 1112/2019, the Authority emphasized its responsibility to ensure the safety, performance, and quality of medical devices.
Under Articles 58 and 59 of the same proclamation, all medical device advertisements and promotional activities must undergo rigorous oversight and evaluation by the Authority.
This legal framework strictly prohibits the promotion of medical devices within health institutions without prior authorization and forbids the offering of illicit benefits to health professionals in relation to product promotion.
The Authority’s Medical Device Evaluation and Market Authorization Lead Executive Office noted that it has historically granted promotional permits only after conducting necessary quality and safety assessments of submitted materials.
However, citing a widespread disregard for these legal procedures, the Authority has mandated that all future advertisements must strictly comply with official approval letters issued by the agency.
The Authority has directed TikTok, YouTube, Facebook, and other media outlets to exercise strict oversight regarding the advertisements they host.
It further cautioned that any individual or entity found continuing to promote medical devices without official authorization will face appropriate legal action.
Moving forward, the Authority affirmed that it will maintain continuous monitoring to ensure that all medical devices are advertised in compliance with legal and quality standards.
