Snapshot

The NAFDAC Emergency Use and Expedited Approval Pathway for COVID‑19 IVDs and Related Devices pathway has been developed by the of Nigeria.

This pathway can be used where NAFDAC created an emergency use approval (EUA) and expedited review pathway for COVID‑19 in vitro diagnostic test kits (antibody and antigen), PPE, and related medical devices.​ Eligibility conditions included prior approval/registration by reference authorities (e.g., USA, EU, Japan, Canada), registration in the country of manufacture, declaration of conformity, and provision of validation or clinical performance data.​ For qualified IVDs and devices, NAFDAC reduced “registration to approval” timelines from 120 to 10 working days using an abridged assessment and reliance approach, coupled with post‑marketing oversight.​ .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Canada Germany Japan United Kingdom United States WHO

Target time assessment is .