A medical device is any instrument, apparatus, software, or in vitro reagent intended by the manufacturer for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury in humans, whose primary action is not achieved by pharmacological, immunological, or metabolic means. From surgical instruments and infusion pumps to HIV test kits, malaria rapid tests, and blood glucose meters, these products directly affect patient outcomes.

The Laboratory Services Directorate of NAFDAC is responsible for quality control of all NAFDAC-regulated products, of which medical devices, including IVDs, are part of. Physical, chemical, microbiological, and serological testing of all medical devices and In Vitro Diagnostics (IVDs) submitted for registration, post-market surveillance, compliance, investigations and even as proficiency testing (PT) to ensures they are safe, effective, and perform as intended throughout their lifecycle to protect public health and keep substandard and falsified products out of the Nigerian market, are done in the laboratory.

Why Quality Control Testing Matters

Globally, substandard and falsified medical products remain a major threat. WHO estimates that 1 in 10 medicines in low- and middle-income countries fails quality control tests, leading to treatment failure, antimicrobial resistance, and preventable deaths (WHO Newsroom, 31 January 2018. Updated November 2017). If this is true for medicines, this is also an alarm for medical devices. In Africa, 42% of WHO reports on substandard and falsified products between 2013-2017 came from the WHO African Region. Medical devices and IVDs are not exempt – falsified rapid test kits, non-sterile surgical instruments, and inaccurate glucose meters have been intercepted in multiple countries.

NAFDAC’s Laboratory Capacity for Medical Devices and IVDs

NAFDAC Laboratory operates as a quality control laboratory under ISO/IEC 17025:2017. For medical devices, including IVDs alone, it has ISO/IEC 17025:2017 accreditation across more than 32 testing scopes. Testing is conducted by product category. For example, for IVDs, testing parameters include sensitivity, specificity, accuracy, and precision. For non-IVDs such as syringes, catheters, surgical gloves, infusion/transfusion sets, condoms, face masks, etc., physical, biological, and mechanical tests such as tensile strength, leak tests, dead space, absorbance, dimensional checks, sterility, microbial limit test, and many more are carried out.

The laboratory tests products using national and international standards such as NIS 990, 291, ISO 7886, 15197, BS EN 4555, EN 14683:2019, British Pharmacopoeia, United States Pharmacopoeia, and many more. With specialized and highly trained personnel and state-of-the-art equipment, globally acceptable testing reports are released on all products received in the laboratory.

NAFDAC’s Commitment

NAFDAC remains committed to ensuring that every medical device and IVD used in Nigeria meets international standards of safety, quality, and performance. The Laboratory continues to expand its testing scope and adopt advanced analytical technologies to keep pace with innovation in the medical device sector. Quality control is not a formality – it is a key step to safeguard the health of every patient who relies on medical devices and IVDs in Nigeria

For information on sample submission, testing requirements, and regulatory updates, visit www.nafdac.gov.ng or contact any NAFDAC office state-wide.