A NAFDAC certificate doesn't say who imports the device

Four risk classes, one registration directorate

NAFDAC — the National Agency for Food and Drug Administration and Control — sorts medical devices into four risk classes under its Medical Devices and Related Products Registration Regulations, 2024: Class A, low risk, through Class D, high risk, the same broad low-to-high shape several markets this blog has already covered run against. Applications for registration or renewal are filed through NAFDAC's own Automated Product Administration and Monitoring System, NAPAMS, and an imported device's file typically opens with a letter of invitation addressed to NAFDAC requesting a GMP inspection of the manufacturing site before a certificate is considered. None of that differs much in shape from the registration regimes this blog has already traced elsewhere. What's distinctive sits one step later, in whose name the certificate the process produces is actually issued.

The certificate doesn't have to belong to a distributor

A foreign manufacturer without its own Nigerian presence can't file for registration directly — the certificate issues in the name of a Nigerian entity, not the manufacturer's own. Nigerian legal commentary on NAFDAC practice describes three ways a foreign manufacturer typically satisfies that requirement: incorporate a local subsidiary, appoint an existing Nigerian company — often an actual distributor — as local representative, or engage a custodial services company whose entire business is holding registrations on a manufacturer's behalf. That third option is the one worth pausing on. A custodial holder has no distribution relationship with the device at all; its only role is to be the name NAFDAC's certificate carries.

A Letter of No Objection does the work the certificate doesn't

Once a custodial company holds a registration in its own name, it can issue a Letter of No Objection authorizing a separate company — the manufacturer's actual distributor — to import the registered device under that certificate. Nothing about the underlying registration changes when it does; the certificate still names the custodial holder, and the Letter of No Objection is a distinct document layered on top of it, one a custodial holder can issue to more than one distributor at once. A reader looking only at NAFDAC's own certificate learns who is legally answerable for the registration. It learns nothing about who is actually moving product through Nigerian ports under that registration's authority this month, because that fact lives in a separate letter the certificate doesn't reference by name.

The two documents don't run on the same clock

A NAFDAC registration is valid for five years before renewal. A Letter of No Objection is a separate authorization, issued and, where the custodial holder chooses, revised or withdrawn on its own terms — nothing in the structure ties its own standing to the registration's five-year cycle. A distributor whose own Letter of No Objection has lapsed, been replaced, or never covered a given shipment in the first place can be operating under a registration that is itself fully current, because the two instruments answer different questions. A compliance team that confirms a Nigerian registration is active and stops there has confirmed the certificate exists, not that the company actually shipping the device today is authorized to.

Where this meets the file

A Nigeria row in a cross-border registration tracker needs the registration holder's own name — local subsidiary, appointed distributor, or custodial company — recorded as its own field, separate from a second field listing which importer currently holds a Letter of No Objection against that registration, since the two can change independently and neither one implies the other's current status. A cross-border tracker built to carry that structure, alongside the launch catalog's other device-registration templates, is previewed there now. If your program has tracked NAFDAC's custodial structure differently, the shelf takes that correction directly.