If you are a European medical device manufacturer for Bucharest, Romania and you’re interested in selling your products in the US, you are required to register annually with the Food & Drug Administration (FDA) – a process known as FDA establishment registration. Owners or operators of business places, also called establishments or facilities involved in the production and distribution of medical devices intended for use in the United States, are required by law to hire a U.S. agent like Medicept. The U.S. agent assists with the communication between the FDA and the company, assisting with recalls, assisting with infections, and assisting with adverse event reporting. We offer this service to take the guesswork out of the registration process and prevent any costly mistakes.
The FDA defines an “establishment” as a facility that is involved in one or more of the following activities:
- Contract manufacturer
- Contract sterilizer
- Foreign exporter
- Initial exporter
- Reprocessor of single-use device
- Specification developer
For Bucharest, Romania businesses, the FDA establishment registration process is just one part of the preparation required for selling a medical device in the United States with which a U.S. agent can provide valuable assistance. Most establishments that are required to register with FDA are also required to list the devices that are made there and/or the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo).
Because this process can be complex, European companies located in Bucharest, Romania and elsewhere in the European Economic Area that are required to complete FDA establishment registration can benefit from partnering with a U.S. Agent experienced in FDA regulatory consulting, such as MEDIcept. This is important because the U.S. Agent may be called upon to speak with the FDA regarding the foreign registered facility, which can be a time-sensitive matter that needs to be addressed quickly and effectively. As a result, it is crucial that the U.S. Agent understands FDA regulations and is able to advise the foreign establishment on FDA medical device regulatory compliance as soon as the need arises.
Contact us today to learn more about the importance of hiring an independent U.S. agent and how MEDIcept can assist your company with FDA establishment registration for Bucharest, Romania and other regulatory compliance issues to help ensure your successful entry into the US market.