Review of the Medical Devices, In vitro Diagnostics and Related Products Advertisement Regulations, 2023

1. Introduction

Medical devices, such as thermometers and x-ray machines, and in vitro diagnostics (IVDs), like pregnancy tests and cholesterol tests, are critical tools for diagnosing, treating, and monitoring diseases all over the world. Related products, such as diagnostic software and calibration tools, support their functionality. In Nigeria, where the growing medical device market faces challenges like counterfeit products and misleading advertisements, the National Agency for Food and Drug Administration and Control (NAFDAC) introduced the Medical Devices, In Vitro Diagnostics and Related Products Advertisement Regulations, 2023, under the NAFDAC Act and the Food, Drugs and Related Products Act (Cap. N1 and F33, LFN 2004). These regulations aim to ensure that advertisements are accurate, ethical, and non-misleading to protect public health and maintain trust in the medical device industry. This review evaluates the regulations’ goals and objectives, key components, alignment with existing laws, strengths, weaknesses, and areas for improvement.

2.  Goals and Objectives of the Regulation

The main goal of the regulation as provided in Regulations 5 is that advertisements of medical devices, IVDs and related products for advertisement shall be accurate, complete, clear and designed to promote credibility and trust by the general public.