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NAFDAC approves first robotic surgery system in West Africa

NAFDAC cuts licensing fees by 65%

The National Agency for Food and Drug Administration and Control has approved the Toumai robotic surgical system for clinical use in Nigeria.

The approval represents a major regulatory milestone, positioning Nigeria as the first country in West Africa to authorise the use of a robotic surgery platform for direct patient care.

The clearance followed a comprehensive assessment of the system’s safety and efficacy, based on the successful conduct of robotic surgical procedures at NISA Premier Hospital in Abuja on November 22, 2025.

NAFDAC disclosed that the surgeries were performed by the Chief Executive Officer of RoboMed, Dr Obi Ekwe, using the Toumai robotic surgical system manufactured by Shanghai MicroPort MedBot.

In a statement issued on Wednesday following the approval, Dr Ekwenna said the regulatory decision was the result of NAFDAC’s extensive evaluation process.

“This approval reflects NAFDAC’s thorough evaluation of the technology’s safety profile. Nigerian patients can trust that this platform meets the highest regulatory standards. They no longer need to travel abroad for world-class surgical care; we have brought it home,” he said.

Information provided by the operators indicated that patients who underwent the initial procedures were discharged within 12 and 48 hours, respectively, after undergoing robotic nephrectomy and prostatectomy.

The service providers noted that these recovery timelines were significantly shorter than those typically associated with open surgical procedures.

The Toumai robotic system operates using advanced three-dimensional visualisation technology and multiple robotic arms to assist surgeons in performing complex procedures with enhanced precision.

The Chief Medical Officer of NISA Premier Hospital, Dr Obi Ekwe, said the introduction of the technology had far-reaching implications for surgical outcomes and patient recovery.

“Robotic surgery delivers precision that the human hand cannot match. Our patients experienced it firsthand: faster recovery, less pain, quicker return to their lives,” he said.

The Chief Operating Officer of RoboMed, Efosa Eluma, said the approval had created a regulatory framework that would enable broader deployment of the technology across the country.

“This is proof that Africa can lead in healthcare innovation. We have built the foundation to scale—this is just the beginning,” he said.

The founder of NISA Premier Hospital, Dr Ibrahim Wada, linked the development to long-standing efforts to reduce outbound medical travel by Nigerians seeking specialised healthcare services abroad.

“We built NISA so Nigerians would no longer need to seek care abroad. Today, that vision is real,” he said.

A public launch of the Toumai robotic surgical platform has been scheduled to take place in Abuja in January 2026.