Nigeria
Nigeria is by far the most populous country on the African continent, having a population of more than 230 million people.
It is currently the world’s sixth-most populous country in the world but with a median age below 20 years it is expected that it will have a higher ranking in the coming decades. Nigeria is a federal republic compromising of 36 states. The capital is Abuja but the largest city is Lagos, being one of the largest metropolitan areas globally and the largest in Africa with over 20 million people.
Around 5% of GDP is spend on healthcare. The majority of this comes from private expenditure, being mostly out-of-pocket expenses to have access to health services in both government and private facilities. Nigeria's healthcare system is a complex network of public and private institutions that provide medical services to over 200 million citizens. The system faces significant challenges, including inadequate infrastructure, a shortage of healthcare professionals (including doctors, nurses and specialists) especially in rural areas, underfunding, and high levels of inequality in access to healthcare services across different regions of the country.
​
Private health insurance coverage is limited, with most Nigerians paying out-of-pocket for medical services. Some states have attempted to implement state health insurance schemes, but these efforts face challenges of accessibility and financial sustainability.
​
Healthcare system structure
The system is structured into three main levels:
-
Primary healthcare (including community-based health services addressing common health problems like malaria, respiratory infections, maternal and child health, and immunization);
-
Secondary healthcare (including general hospitals, regional hospitals, and some specialized clinics that handle more complex cases, often referred from primary healthcare centres. It provides more specialized care for conditions such as infections, injuries, and chronic diseases);
-
Tertiary healthcare (involving highly specialized care, often provided by teaching hospitals (like LUTH, https://luth.gov.ng/) and specialist centres in major cities. It includes advanced medical procedures like cancer treatments, organ transplants, and highly specialized surgeries).
Public Healthcare: The government plays a dominant role in providing healthcare through federal, state, and local government institutions. Unfortunately, the public sector is underfunded and often lacks the necessary resources to provide quality care. Major public healthcare providers include federal teaching hospitals, state general hospitals, and local government clinics.
Private Healthcare: The private sector in Nigeria also plays a significant role in healthcare provision, particularly in urban areas. Private hospitals, clinics, and pharmacies are often perceived to offer better services compared to public institutions. However, healthcare in private settings is costly and therefore not available to all Nigerians.
​
​
Key health issues
-
Infectious Diseases: Diseases such as malaria, tuberculosis, cholera, and HIV/AIDS remain major health concerns in Nigeria. Especially malaria continues to be a leading cause of morbidity and mortality.
-
Maternal and Child Health: Nigeria has one of the highest maternal mortality rates in the world. Poor access to antenatal care, unsafe childbirth practices, and inadequate health infrastructure contribute to these high rates.
-
Non-Communicable Diseases (NCDs): The rise of lifestyle-related diseases such as hypertension, diabetes, and cancer is increasingly challenging the healthcare system, adding a new layer of complexity to healthcare provision.
-
Mental Health: Mental health is often neglected in Nigeria, with insufficient services and a persistent social stigma surrounding mental illness.
Medical device and IVD registration
No Medical Device and/or IVD shall be imported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDA Act CAP N1 (LNF) 2004, other related Legislation.
The registration of medical devices and In Vitro Diagnostics (IVDs) is regulated by the NAFDAC, the National Agency for Food and Drug Administration and Control (https://nafdac.gov.ng/), which is the government body responsible for ensuring the safety, efficacy, and quality of medical devices, drugs, and other regulated products in the country.
Foreign manufacturers must appoint a Local Authorized Representative (LAR), which could be either a company or an individual fully registered in Nigeria.
​
The LAR must have a good understanding of Nigeria’s regulatory environment and medical device market. It serves as the liaison between the manufacturer and NAFDAC and is responsible for submitting the registration application, handling regulatory communications, and ensuring compliance with NAFDAC regulations.
Medical devices and IVDs classification
Medical Devices and Related Products: The classification of medical devices and related products shall be as stated below according to their risk level:
-
Class A (low risk)
-
Class B (low-moderate risk)
-
Class C (moderate-high risk)
-
Class D (high risk)
-
Any other class as the Agency may deem fit.
Where a medical device and related products belongs to more than one class, the class representing the higher risk shall applies.
In vitro diagnostics: The classification of IVDs shall be as stated below:
-
Class A: Low individual risk and low public health risk;
-
Class B: low to moderate individual risk and/or low public health risk;
-
Class C: high individual risk and/or moderate public health risk;
-
Class D: high individual risk and high public health risk.
Registration process, approval and issuance of Registration Certificate
The Application for the registration or renewal of registration of all MDs and IVDs should be submitted and processed on the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) portal (https://registration.nafdac.gov.ng)
​
The process for registering medical devices and IVDs in Nigeria involves several steps, including:
Step 1: Documentations and GMP Inspection: the LAR is requested to upload all the required documents on the NAPAMS portal, and then to submit the hard copies of these same documents upon request.
A full Dossier with Administrative documentation, Technical documentation as well as a Plan for post-Market Surveillance is requested.
Alongside with this procedure, a GMP Inspection of the manufacturing facility is conducted (where applicable - for both imported and locally manufactured medical devices)
​
Step 2: Import Permit: Upon successful screening of documentation and after review of supporting documents, a permit to import for the importation of registration samples for laboratory testing shall be issued.
Step 3: Submission of products for laboratory analysis.
Step 4: Product(s) approval meeting: upon satisfactory documentation review, GMP inspection of the product facility and laboratory analysis of the products (where applicable), product(s) subject to be registered are presented for the Food and Drug Registration Committee during the approval meeting.
Step 5: Issuance of Notification: For products approved at the committee meeting, an electronic Certificate of Product Registration (CPR) is issued to the Applicant.
Post-Registration Requirements: This includes but is not limited to:
-
Post-Market Surveillance: monitoring the product’s performance once it is on the market, including reporting adverse events or product defects.
-
Product Recalls: if there are safety concerns, the manufacturer may need to initiate a product recall and inform NAFDAC.
-
Renewal of Registration: registration must be renewed periodically, and the manufacturer must provide updates on product changes or new evidence regarding the device's safety and efficacy.
-
Change / variations notifications: report on all changes and/or variation that might occur in any document included in the registration dossier.
-
Distribution control: proper distribution channels must be established, and medical devices and IVDs should only be sold through authorized distributors.
Special Requirements for In Vitro Diagnostics (IVDs)
IVDs are subject to some specific regulatory requirements in addition to what Medical devices are subject to, mainly due to their diagnostic nature.
Gateway MedTech can support in Nigeria market entry and regulatory support and act as your local AR.
