Ensure your foreign medical device manufacturing business complies with FDA regulations. Our official correspondent services guide you through the US regulatory landscape.
Designate an official correspondent
Firstly, a foreign manufacturer of a medical device, looking to market it within the US, needs to designate an official correspondent. An official correspondent is the liaison point between you and the US FDA and is responsible for compliance under the FDA.
Check State Regulations
Each state has different legislation on the requirements to register a distributor. Make sure you research the state law where your distributor will be located to ensure you are meeting all its requirements. This could be as straightforward as obtaining a business license, registering with the Secretary of State and payment of any registration fees.
Registration with the FDA
The second step that the official correspondent undergoes in a registration process is to register with the FDA. It entails filling in an online form of registration together with the details of the foreign manufacturer’s name, address, and other contact information. The official correspondent should also include the details of the medical devices marketed within the US including their intended use and classification. The official correspondent also serves as the US agent for the foreign medical device manufacturer. The official correspondent, therefore, must be provided with a US mailing address where the FDA can direct any correspondence relevant to the said medical devices. The official correspondent will receive and respond to any correspondence received from the FDA on behalf of the foreign manufacturer.
Retention of Records
The official correspondent is also supposed to maintain documents of the medical devices marketed in the US. The documents here would include aspects such as the design, manufacture, and distribution of the medical devices. The official correspondent must be able to supply the records to the FDA in case they request them.
Reporting Adverse Events
If any form of adverse medical event stemming from the use of those medical devices occurs within the US geographical region, the FDA is in charge, and its official correspondent informs the medical authority about the occurrence of such an event. This includes severe injuries and death, and other incidents that are going to become a safety issue concerning the involved medical devices.
Compliance
Finally, the official correspondent is responsible for ensuring that it complies with FDA rules and regulations. This ensures that the medical devices meet the required FDA standards and regulations and, any change in the medical devices are reported to the FDA. The official correspondent shall ensure that the medical devices are labeled and marketed within the US.
Conclusion
The official correspondent would play a role in complying with FDA regulations for foreign medical device manufacturers. They are involved in registering with the FDA, serving as a US agent, maintaining records, reporting adverse events, and maintaining compliance. The official correspondent must help the foreign manufacturer to succeed in navigating the complex regulatory landscape of the US medical device market.
Contact BioBoston Consulting today or visit our website for more information on how we can support your organization.
