What is an Initial Importer?
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In the vast majority of cases, foreign manufacturers find out about an initial importer upon registering their products with the FDA in preparation for importation. Usually it is presented to them as a regulatory requirement that must be fulfilled prior to importing medical devices into the United States. While this is definitely true, foreign manufacturers are oftentimes unaware of the additional benefits the one receives in being represented by an initial importer. Indeed, an initial importer can save a manufacturer both time and money.
Your Return on Investment
Importing medical devices into the United States is a meticulous process. There are many rules and regulations that foreign manufacturers must abide by in order for their products to be cleared once they arrive in the US. In the case of medical devices, clearance is a two-step process that is conducted by two separate entities. The first entity, Customs, is standard to all imports. Customs is mainly concerned with collecting tariffs and controlling the flow of goods into and out of the country. The other entity is known as a ‘Partner Government Agency’, or an agency that works alongside Customs to regulate specialized products with which their agency has jurisdiction over. In the case of medical devices, that would be the US Food and Drug Administration (FDA). FDA regulations concerning medical devices are very specific, and even accidental omissions of documentation or information can cost a foreign manufacturer thousands in fees and confiscated goods. That is why the assistance and expertise of an initial importer can be extremely helpful. Not only does Dawa Medical ensure your imports and corresponding supplementary documentation are in full compliance with FDA guidelines, but we also correspond with Customs on your behalf should any problems arise.
As you are probably well aware, the process of getting medical devices cleared by the FDA is complicated at best. This is especially true for foreign manufacturers who are unfamiliar with United States federal regulations. Having a point of contact to reach out to regarding regulatory questions that need immediate attention is undeniably helpful. At Dawa Medical, we pride ourselves in the fact that we will respond to questions however many times you need, whenever you may need it.
Obviously, the whole point of importing medical devices into the United States is to take advantage of opportunities that are presented by its lucrative medical device market. In order to optimize your success, it is important to have a partner in the United States with distribution networks and expertise in the market. That is what is afforded to you should you want to take advantage of it when you request that we represent you as your initial importer. Dawa Medical prides itself in the extensive networks that have been forged since its founding.
Not All Initial Importers Are Created Equal
While there are many potential benefits of having an initial importer that go beyond fulfilling a basic regulatory requirement, this is only the case when you obtain an initial importer that is willing to put forth the work in helping you succeed. Your ideal initial importer would have standard operating procedures in place, would be ready to assist with your importations at any moment, and would have the necessary expertise in both FDA import regulations and the overall medical device market. Too often, Dawa Medical receives clients who were unhappy with their previous initial importer due to their lack of expertise and assistance with importations. An extremely low price-tag can be deceiving. Many so-called “initial importers” will collect your money so that you can label them as your initial importer, but they will cease to provide any other services or assistance that can be beneficial to your business. Dawa Medical is committed to your company’s success, and we will help in any way possible to ensure that you succeed.