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Regulatory Center

510k Submission Steps

510k Submission Steps

510k information

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

Authorised representative overview

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

Authorized Representative

The Role of AF Pharma as an Authorized Representative

Authorized Representative EU

Authorized Representative work

Authorized Representative Medical Devices 2023

AF Pharma - Your European Authorized Representative for Medical Devices

Canada license

Canada license for medical devices

Cosmetic UK updates July 2023

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

Cosmetic registration in Europe

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

EC Rep and MDR Compliance

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

EU Custom-made Device Statement

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

EU Declaration of Conformity for MDD-AIMDD-IVDD

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

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