Snapshot

The NAFDAC Medical Devices, Including In-Vitro Diagnostics (IVD) Draft Regulation 2025 pathway has been developed by the of Nigeria.

This pathway can be used where Covers all classes (A-D) of medical devices including IVDs such as reagents, test kits, instruments, and related accessories Establishes a risk-based classification and a comprehensive regulatory framework aligned with global standards (ISO 13485, IMDRF principles). Enables a formal registration process with technical file submission, conformity assessment, and emphasis on postmarket surveillance. Includes potential for accelerated registration through alignment with international standards and recognized Quality Management Systems.. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is .