The National Agency for Food and Drug Administration and Control (NAFDAC) was formally accepted by the International Medical Device Regulators Forum (IMDRF) as an Affiliate Member on the 22nd of March 2024.
The IMDRF is a voluntary group of global medical device regulators worldwide who have come together to accelerate international medical device harmonization and convergence.
To this end, NAFDAC had to review its existing guidelines and processes to align with the IMDRF guides while also drafting new ones for relevant regulatory processes.
In view of the above, NAFDAC has reviewed its Dossier submission requirements from the Summary of Technical Documentation (STED) Template to the IMDRF ToC format. Also, NAFDAC is moving away from only using the dossier checklist process to full dossier review process, starting with IVD test kits for priority diseases (WHO PQ Classification).
Therefore, a roadmap for transitioning is hereby developed to ensure a smooth implementation of this process that allows for monitoring and evaluation, Click to Download full Document.
