The National Agency for Food and Drug Administration and Control (NAFDAC) has issued Public Alert No. 010/2026 following a Notice of Concern released by the World Health Organization Prequalification Service regarding certain medical devices produced by Meril Diagnostics Pvt. Ltd..
NAFDAC said the Notice of Concern was issued after significant violations were identified during a WHO Prequalification audit of the company’s manufacturing facility in India.
According to NAFDAC, the findings led to a declaration that the manufacturer was not operating in compliance with WHO requirements and applicable quality standards, raising concerns about the safety and quality of the affected medical devices.
The agency informed that although the products are registered with NAFDAC, the Marketing Authorization Holder, KVATH Int’l Ltd, confirmed that the devices have not been imported into Nigeria. The company attributed this to its current non-operational status following external policy changes.
NAFDAC, therefore, warned that any of the affected products found within Nigeria would be regarded as falsified, counterfeit, and fraudulently imported.
The agency reaffirmed its commitment to protecting public health through continued surveillance to ensure the quality, safety, and efficacy of medicines, medical devices, and other regulated products in circulation across the country.
Healthcare professionals have been advised to review stocks in hospitals, clinics, and pharmacies and report any suspected falsified or compromised products to the nearest NAFDAC office.
It further advised that reports can also be made via the agency’s hotline at 0800-162-3322 or by email to sf.alert@nafdac.gov.ng.
