Medical Device Regulation and NAFDAC Compliance in the Nigerian Medical Equipment Market: A Professional Assessment

The Nigerian medical device market encompasses a large proportion of imported equipment from diverse origin countries, and the regulatory oversight exercised by NAFDAC over device safety, performance, and registration has significant implications for patient safety and healthcare quality. This study professionally assesses the current status of medical device regulation and NAFDAC compliance in the Nigerian medical equipment market, combining documentary regulatory analysis, manufacturer and distributor interviews, and a market survey of device registration status. Regulatory framework analysis covers the NAFDAC Medical Devices and Diagnostics Act, registration requirements, post-market surveillance powers, and their comparability with global benchmarks including EU MDR 2017/745, US FDA 21 CFR Part 820, and WHO global model regulatory framework. A survey of sixty medical devices actively marketed in Nigeria across five device categories assessed the proportion bearing valid NAFDAC registration numbers on packaging and marketing materials. Market survey results show that forty-eight percent of surveyed devices displayed valid NAFDAC registration numbers, with the lowest compliance rates in the in vitro diagnostic and physiotherapy device categories. Distributor interviews reveal widespread unfamiliarity with registration requirements for Class IIb devices and lack of clarity on quality management system documentation requirements. Post-market surveillance activities by NAFDAC were assessed as limited relative to the size of the market, with reactive recall actions predominating over proactive surveillance. The study recommends a risk-based device classification enforcement prioritization, NAFDAC capacity strengthening, and a digital device registry accessible to health facility procurement officers. Keywords: medical device regulation, NAFDAC compliance, Nigerian market, post-market surveillance, patient safety.