Authorized Representative Medical Devices 2023
AF Pharma - Your European Authorized Representative for Medical Devices
Are you a non-European medical device manufacturer seeking to access the lucrative European market?
Look no further than AF Pharma, your dedicated and reliable European Authorized Representative (EC Rep). We are here to bridge the gap between your innovative medical devices and the European Union, ensuring a smooth and compliant entry into this thriving market.
Why Choose AF Pharma as Your EC Rep?
Expertise and Experience: With years of experience in the industry, AF Pharma boasts a team of regulatory experts well-versed in the complexities of the European medical device market. We understand the intricacies of the EU MDR 2017/745 and IVDR 2017/746 and will navigate the regulatory landscape on your behalf.
Seamless Market Access: Partnering with AF Pharma means gaining access to the vast and diverse European market. We will handle all regulatory requirements, registrations, and interactions with competent authorities, saving you time and resources.
Compliance Assurance: Compliance is at the heart of what we do. AF Pharma will ensure that your medical devices meet all necessary regulatory standards, making certain that you stay fully compliant with the EU regulations at all times.
Dedicated Support: At AF Pharma, we pride ourselves on providing personalized and responsive support to our clients. You will have a dedicated account manager who will be there to address your needs and concerns throughout the entire process.
Cost-Effective Solution: Building your own presence in the EU can be costly and time-consuming. AF Pharma offers a cost-effective solution, allowing you to focus on innovation and growth while we take care of your regulatory obligations.
Our Services - Your Pathway to Success
Regulatory Representation: As your trusted EC Rep, AF Pharma will act on your behalf in all regulatory matters, ensuring your interests are safeguarded and your devices remain compliant.
Documentation Management: We will meticulously maintain all required technical documentation, EU declarations of conformity, and relevant certificates, making them readily available to competent authorities when needed.
Collaborative Approach: We work closely with competent authorities and relevant bodies to implement any necessary preventive or corrective actions, fostering a seamless collaboration for a successful market presence.
Incident Reporting and Compliance Updates: AF Pharma will promptly handle any complaints or incidents reported by healthcare professionals, patients, or users. We will also keep you informed about any regulatory news and updates that may impact your devices.
Smooth Transition: If you are already working with another EC Rep, our experienced team will ensure a smooth transition and handle all necessary arrangements to represent your devices effectively.
Timelines for Key Services:
EC REPRESENTATIVE: Engaging AF Pharma as your EC Rep can be completed within 2 working days.
EU REGISTRATION: Our team will handle all registration requirements within 2 working days.
FREE SALE CERTIFICATE: AF Pharma will obtain the necessary Free Sale Certificate for your medical devices within 15 working days.
Partner with AF Pharma Today!
At AF Pharma, we understand the significance of a strong and reliable European Authorized Representative for your medical devices' success in the EU market. Let us be your trusted partner in navigating the regulatory landscape, ensuring compliance, and opening doors to endless opportunities.
Contact us now to explore how AF Pharma can be your strategic European Authorized Representative and take your medical devices to new heights in the European market. Together, we can build a prosperous future for your business in the European Union.