The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians against using or circulating certain medical devices manufactured in India, following safety concerns raised by the World Health Organization (WHO) over quality standard violations at the production facility.
The caution follows a Notice of Concern (NOC) issued by WHO’s Prequalification Service after an audit revealed significant non-compliance with required quality and safety standards, casting doubt on the reliability of the affected devices.
In a statement on Tuesday, NAFDAC clarified that while the devices have been registered in Nigeria, the Marketing Authorisation Holder, KVATH Int’l Ltd, confirmed that the products have not yet been imported.
“It is important to note that the above-mentioned products, if found in the country, will be considered falsified, counterfeit, and fraudulently imported,” the statement read.
The Agency stressed that any such devices discovered in Nigeria will be subject to regulatory action. NAFDAC also reaffirmed its commitment to safeguarding public health through intensified post-marketing surveillance and enforcement to ensure that only products meeting established standards of quality, safety, and efficacy remain in circulation.
Healthcare professionals, including hospital administrators, clinicians, and pharmacy operators, have been advised to review their inventories immediately and remain vigilant.
The Agency urged prompt reporting of any suspected falsified or compromised products to the nearest NAFDAC office, via the toll-free line 0800-162-3322, or by email to sf.alert@nafdac.gov.ng
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