From Draft To Implementation: Compliance obligations under NAFDAC’s medical devices and IVDs draft regulations, 2025

Introduction

Nigeria has historically operated without a dedicated, consolidated statutory framework governing medical devices. Regulatory oversight has instead been exercised by the National Agency for Food and Drug Administration and Control (NAFDAC) pursuant to its general mandate under the NAFDAC Act (Cap N1, Laws of the Federation of Nigeria 2004), complemented by registration guidelines, import permit requirements, and post-market enforcement measures. While this regime has been largely functional, it has given rise to fragmented and sometimes unclear compliance obligations, particularly in relation to emerging technologies such as software-enabled medical devices and complex diagnostic products.

The absence of a comprehensive statutory regime created regulatory uncertainty for manufacturers, importers, distributors, and healthcare providers. Key obligations, including product classification, technical documentation, quality management systems, post-market surveillance, and supply chain accountability, were interpreted and enforced unevenly, resulting in limited predictability and unclear compliance.

To address these gaps, NAFDAC published the Draft Medical Devices, including In Vitro Diagnostics and Related Products Regulations, 2025, for stakeholder consultation, opening comments in July 2025. These Regulations aim to provide a structured, risk-based regulatory framework covering device lifecycle activities, from clinical investigation through post-market surveillance, safety reporting, and recall mechanisms.
Against this backdrop, this article examines the regulatory transition, an overview of the draft Regulations, and practical compliance strategies for regulated entities preparing for implementation.

Regulatory Transition and the Business Case for Proactive Compliance

NAFDAC’s recent enforcement actions indicate a sustained focus on manufacturing standards, product quality, and market surveillance. Between 2022 and 2025, the Agency issued public alerts and recalls addressing substandard products, inadequate laboratory compliance, misleading labelling, and post-market quality issues, for example, in Public Alert No. 031 of 2025, NAFDAC warned stakeholders about the presence of an unauthorised and unregistered Darzalex (Daratumumab) injection in Nigeria, highlighting deficiencies in import control and regulatory traceability. . Such alerts often result in immediate withdrawal of affected products from circulation and heightened scrutiny of related product registrations.

Similar enforcement trends have emerged in relation to medical devices and diagnostics. NAFDAC has increasingly drawn attention to the illegal retailing and marketing of health and wellness products, including diagnostic kits and medical consumables sold without appropriate authorisation. From a commercial standpoint, these enforcement measures carry significant implications. Product recalls, import detentions, and registration suspensions disrupt supply chains, undermine contractual commitments, and expose companies to reputational risk. Conversely, businesses that embed regulatory compliance into operational planning are better positioned to maintain market access and participate in formal procurement and distribution channels that are increasingly closed to non-compliant operators.

Overview of the Proposed NAFDAC Medical Devices Draft Regulations 2025

A clear illustration of NAFDAC’s 2025 regulatory transition can be found in the NAFDAC Medical Devices, including In-Vitro Diagnostics and Related Products Draft Regulations, 2025 (the “Medical Devices and IVDs Regulations”). Although the Regulations are currently issued in draft form and are yet to be gazetted, they provide a consolidated view of the Agency’s evolving regulatory philosophy for non-medicinal health products.

The draft Regulations introduce formal classification of medical devices and IVDs based on risk profile and intended use, with differentiated regulatory obligations attached to each class. This includes graduated requirements for technical documentation, conformity assessment, and quality management systems. For manufacturers and importers, this represents a shift from registration as a discrete event to compliance as a continuous obligation that spans product design, manufacture, importation, distribution, and post-market use.

Notably, the draft Regulations place significant emphasis on post-market surveillance. They outline obligations relating to adverse incident reporting, corrective and preventive actions, recalls, and product traceability. These provisions reflect NAFDAC’s increasing enforcement focus on market surveillance, as demonstrated by recurring public alerts, import refusals, and seizures of unauthorised or substandard medical devices and diagnostic products in recent years.

While such actions have previously been grounded in general statutory powers under the NAFDAC Act, the draft Regulations consolidate these expectations into a coherent compliance framework.

The Regulations also clarify regulatory responsibility across the supply chain by expressly recognising the roles of manufacturers, importers, distributors, and local authorised representatives. This clarification aligns with NAFDAC’s observable enforcement practice of holding local entities accountable for compliance failures involving imported health products, including diagnostic kits and laboratory consumables.

From a business perspective, the relevance of the Medical Devices and IVDs Regulations lies not in their immediate legal commencement, but in how they crystallise NAFDAC’s regulatory direction. Companies operating in the medical devices and diagnostics space are increasingly expected to demonstrate compliance readiness through documented quality systems, traceability mechanisms, and functional post-market controls. Firms that proactively align their operations with the draft framework are better positioned to manage inspections, secure approvals, and maintain uninterrupted market access as NAFDAC’s regulatory architecture continues to mature toward 2026.

Compliance Strategies for Manufacturers, Importers, Distributors, and Healthcare Providers
As the NAFDAC Medical Devices, including In Vitro Diagnostics and Related Products Regulations, 2025 continue through stakeholder consultation and toward finalisation, regulated entities must align their operations with specific lifecycle, quality, and post market requirements articulated in the draft Regulations. The strategies below map directly to identifiable regulatory obligations and implementation expectations.

1. Lifecycle Quality and Risk Management Systems

The draft Regulations require manufacturers to integrate lifecycle quality and safety considerations into design, manufacturing, and post-market activities to ensure ongoing device performance and risk control. While the draft does not explicitly use the term “risk management system,” its objectives and application sections underscore comprehensive regulatory oversight throughout clinical investigation, manufacturing, distribution, and post-market stages.

Manufacturers would have to adopt formal risk-based quality management systems that document how risks are identified, mitigated, controlled, and monitored throughout the device lifecycle, aligning with the Regulation’s objective to protect health and ensure product safety from design through post market activities.

2. Competent Personnel and Training

The draft Regulations apply to clinical investigation, manufacture, registration, labelling, post-market surveillance, and vigilance for devices. The broad scope reflects an expectation that regulated entities have personnel with appropriate competencies to fulfil these functions and comply with the Regulation’s lifecycle application.