Medical Devices

"...help me with my answering ALL of my medical device importing and customs questions"

- Thomas, President, Medtribution

Our approach

In 2020, medical devices like facemasks and respirators became important virtually overnight. But even after the effects of the coronavirus subside, the importance of remaining compliant with FDA regulations will remain for medical device importers. We stay up to date with the fast-paced changes of FDA regulations for medical devices to keep importers informed and compliant. We also do pre-shipment auditing to ensure that the correct level of registration is current for each medical device. We are fluent in FURLS – the FDA’s portal for medical device importers.

Services we provide:

FURLS account setup

Services our consultants provide:

1. FDA medical device establishment registration
• Foreign
• Domestic


2. 510(k) application

A story from our clients

 "I have been dealing with James R., who has been such a pleasure to work with. After contacting multiple customs broker, I went with him at Juliana Lim CHB.  James has gone far beyond his duties to help me with my answering ALL of my importing and customs questions. So far he has helped me import medical devices, which cleared with ease. […] I want to thank James and highly recommend him and the company!”

 

- Thomas, President, Medtribution

(https://shop.medtribution.com/) 

Industry we serve