US Agent (Medical Devices)
HTC is pleased to offer our US Agent services.
If you are a non-US medical device manufacturers without a US address and want to sell your products in the US, you are required to retain a US Agent with a physical address within the USA. We provide you with more than just an address; as your US Agent, we provide you with up-to-date regulatory and compliance information at no extra fee. US Customs can be a real challenge; as your US Agent, we can assist you if a problem should arise with importation of your product into the United States.
As part of our US Agent Service, we also offer Official Correspondent services. With HTC as your Official Correspondent, you have professionals that are in same time zone as the FDA which makes it easier for the Agency to communicate any issues that may come up. With our extended work hours (7 am to 10 pm Eastern US Time), we are able to contact you during your normal operating hours. As your Official Correspondent, we can assist in communications with the FDA and your US distributor if necessary.
Establishment Registration and Listing (Medical Device)
In addition to our US Agent Service, HTC can also file your Establishment Registration and Device Listing. We can combine our Agent Service with the Registration and Listing as an annual package for you.
US Agent (Clinical Trials)..
HTC also offers a separate US Agent service for non US companies (Devices and Pharma) that want to conduct clinical trials in the US but do not reside or have a place of business within the United States. We have both Agent and Attorney services available.
Please contact us if you have a need for this specialized service.