In a landmark development for Nigeria’s healthcare sector, the National Agency for Food and Drug Administration and Control (NAFDAC) has called for increased local production of medical devices, following the historic certification of AFRI Medical Manufacturing and Supplies Limited by the World Health Organisation (WHO).
AFRI Medical’s 0.5ml auto-disabled syringes have become the first in Nigeria—and the entire West and Central African region—to earn WHO pre-qualification. This move positions the country on the global medical device map.
NAFDAC director general, Prof. Mojisola Adeyeye, announced the milestone at a press briefing held at the agency’s Isolo office in Lagos on Wednesday, describing the certification as a testament to the success of Nigeria’s regulatory efforts and the growing capacity of local manufacturers to meet international standards.
“This feat was not achieved overnight.
It results from a rigorous process, heavy investment by AFRI Medical, and consistent guidance and support from NAFDAC. Today, their product is on the WHO list of pre-qualified medical devices, making it eligible for international procurement by UNICEF and other global bodies,” Adeyeye stated.
She emphasised that this achievement will enable AFRI Medical to export high-quality syringes globally, expanding Nigeria’s international medical device industry footprint. Adeyeye says this aligns with the Federal Government’s industrialisation agenda and President Bola Ahmed Tinubu’s broader policy to enhance domestic productivity.
“As a regulator, NAFDAC has adopted global best practices to ensure that only quality and safe products are manufactured and distributed. This WHO pre-qualification is not just a win for AFRI Medical, but a national success story,” she said.
The NAFDAC boss urged other local manufacturers to work toward global certifications, revealing that the agency had laid the groundwork since 2019. One such step was the implementation of the “5+5” regulatory directive, which discourages the continued importation of goods that can be locally produced after their initial five-year registration cycle.
Adeyeye also cited lessons from the COVID-19 pandemic as a catalyst for change. “We discovered how fragile our reliance on imported medical devices can be. This prompted us to evaluate the quality of locally manufactured syringes. While some products met the required standards, others did not, prompting our technical support and monitoring program,” she said.
Through field investigations, laboratory testing, and “hand-holding” collaborations with manufacturers, NAFDAC provided technical guidance, conducted unannounced inspections, and encouraged improvement. “The results were shared with manufacturers, and today, AFRI Medical stands as a shining example of what can be achieved,” Adeyeye added.
AFRI Medical’s general manager, Mr. Gabi Al-Aridi, on behalf of the certified company, described the WHO endorsement as a “milestone achievement” for the firm and Nigeria. He noted that the recognition enables AFRI Medical to supply syringes to global agencies such as UNICEF, further boosting Nigeria’s export potential. “This means that AFRImedical Nigeria can now export syringes with the highest level of WHO certification, as well as ISO and market clearance certifications,” Al-Aridi said.
