Regulatory Center

510k Submission Steps

Understanding the 510(k) Process: AF Pharma Expert Consultants Can Guide You

AF Pharma as Your Authorized Representative (EC Rep) in Europe

The Role of AF Pharma as an Authorized Representative

Authorized Representative work

AF Pharma - Your European Authorized Representative for Medical Devices

Canada license for medical devices

New Cosmetic Regulations in the UK and EU: How AF Pharma Can Help as UKRP

Compliance with the EU CPNP Portal and Unlocking Market Access for a Wide Range of Cosmetic Product Categories

Role of an EU Authorized Representative in Medical Device Compliance (MDR)

Meeting Minimum Requirements: Crafting a Comprehensive Manufacturer's Statement for Medical Devices under MDR Guidelines

EU Declaration of Conformity: Requirements, Considerations, and Legacy Device Considerations