Sell medical device in US

Steps to sell in the US
US Agent guide as per FDA

Having a regulatory strategy for the determination of the FDA path (510(k), PMS, de novo) is the first step to marketing medical devices in the USA market. Our team of expert consultants in medical device and USA - FDA regulations will guide you in this process. Contact us to act as your FDA US Agent and provide you with the full service.

US Agent

Gain the FDA clearance

Manufacturers need to gain the FDA clearance for all medical devices and IVDs before the products can be sold in the USA.

Ancla 1

Appoint an US Agent

Non USA-Manufacturers must appoint an FDA-US Agent.

Establishment registration

Device listing

Register Company and Devices

Your company and devices must be registered in the FDA database, the by the Establishment Registration and Device Listing. The US Agent must be able to help you.

Regulatory services

Appoint an Initial Importer

For selling your devices in the USA, it is mandatory to have an initial importer when you are not a USA-manufacturer.

Importers shall be identify in the medical devices documentation and in the Device Registration.

US Agent services for medical devices

Welcome to AF Pharma for navigating the intricate landscape of FDA regulations for medical devices in the USA. As the premier US Agent, we specialize in guiding manufacturers through the complexities of FDA compliance, ensuring a seamless pathway for your product's entry into the market. With our wealth of experience and expertise, we excel in crafting essential FDA documents, including 510(k) submissions, essential for your device's approval. We understand that comprehending FDA regulatory strategies is pivotal for manufacturers, and our team of expert consultants is here to support you at every turn.

Determining the optimal FDA pathway is the cornerstone of regulatory compliance. Whether it's through 510(k) clearance, Post-Market Surveillance (PMS) requirements, or the innovative de novo pathway, our consultants collaborate closely with you to tailor a regulatory strategy aligned with your device's characteristics and intended use. When it comes to preparing FDA documentation, such as 510(k) submissions, our proficiency is unmatched. We possess an in-depth understanding of FDA expectations, encompassing clinical data, performance testing, and risk assessment. Additionally, we offer guidance on alternative regulatory pathways, such as the de novo process or PMS requirements, ensuring your compliance while maximizing market entry success.