With many years of experience and dozens of clients all over the globe, Dawa Medical is capable of ensuring that your business conforms to US Food & Drug Administration (FDA) regulations. Not only do we serve as a regulatory requirement for foreign manufacturers, but we also assist in navigating the complexities of medical device regulations. This is critically important to saving your company time and money. Furthermore, our initial importer services offer foreign manufacturers a gateway into Dawa Medical’s extensive distribution network. Our relationship with your company as an initial importer will go beyond regulatory requirements so that you can optimize business in the US market.
OUR ROLE AS YOUR INITIAL IMPORTER
WHAT IS AN INITIAL IMPORTER?
An initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations. These requirements are, but not limited to:
- Establishment must be registered with the FDA
- Establishment must have a physical address in the United States, as well as a staffed by responsible individuals to ensure the compliance of all FDA laws and regulations.
- Responsible for registering, reporting, and archiving all non-conformities, customer complaints, recalls and all post-market survey activities.
- Responsible for Medical Device Tracking of certain devices through the supply chain.
MAKE DAWA MEDICAL MY INITIAL IMPORTER
The process of obtaining Dawa Medical as your initial importer is quite simple. Contact Us via our contact form and request an estimate for our services. We will reach out to you to obtain any pertinent information regarding your company’s needs and create a service agreement accordingly. You will then be on your way to taking advantage of the lucrative medical device market in the United States with Dawa Medical by your side at every step of the process.