Headquartered outside Boston, MA, MEDIcept has provided expert medical device consulting for over two decades. Meeting FDA requirements is the first step for international medical device manufacturers looking to distribute products in the United States. With MEDIcept’s FDA establishment consulting, we’ll guide you through registering your company annually, listing your medical devices, and appointing a U.S. FDA Agent.
US Market Expertise for European Companies
When bringing products to the US market, European manufacturers are also required to list their devices with the FDA. If a device requires premarket approval or notification, manufacturers must submit a premarket submission number, such as 510(k), PMA, or De Novo. MEDIcept’s FDA establishment consulting local to Hong Kong, HK, simplifies this process, helping you avoid costly errors and ensure full compliance. The FDA defines a “manufacturer” as anyone involved in the design, production, or assembly of a finished device, including roles such as:
- Contract manufacturer
- Contract sterilizer
- Manufacturer
- Repackager
- Relabeler
- Remanufacturer
- Specification developer
Trusted US Registration Support
As part of the registration process, the FDA mandates that all medical device and in vitro diagnostic (IVD) companies without a U.S. presence appoint a registered U.S. FDA Agent. This agent must reside or maintain a business in the U.S. and is responsible for:
- Handling FDA communications
- Responding to FDA inquiries regarding devices offered for import into the U.S.
- Assisting with FDA inspection scheduling
Given the complexities of these Federal processes, medical device and IVD manufacturers for Hong Kong, HK, or other U.S. and European Economic areas can benefit greatly from partnering with an experienced U.S. FDA Agent like MEDIcept. Our team provides expert FDA Establishment Consulting for Medical Device Companies, to guide you through establishment registration, device listing, and beyond to support your successful entry into the U.S. market.
Contact us today to learn more about our U.S. FDA establishment consulting and how MEDIcept can assist your company in meeting requirements for an FDA agent and device listing, along with other regulatory consulting services.