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Exporting and selling medical devices into the United States of America

If you want to sell medical devices in America, you need to obtain FDA approval for the device.

You need approval from the FDA [Food and Drug Administration] to import and sell medical devices in the United States of America.

Approval by the FDA Center for Devices and Rediological Health (CDRH) is required to export any kind of medical device to the United States. The procedure involves various steps: first of all it is necessary to determine whether the product is considered a “medical device.” If not, authorization will have to be asked to other FDA departments. 
 
The device must then be classified according to CDRH rules. Depending on the characteristics of the product, it may be placed in regulatory classes I, II or III.
 
Classification is very important, as requirements and regulation vary accordingly. For example, while  many class I products are eligible for exemptions, class III products require a more detailed set of documents. 
 
Preparation and presentation of the marketing application is the last and fundamental step to obtain FDA approval. 
 
It is worth noting that importers should make sure the device meets all labeling requirements as well. 
 
Finally, the company will register at the FDA and declare the products it intends to sell on the American market.
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Exporting and Selling Cosmetic Products in the United States

ExportUSA helps companies export and sell cosmetic products in the United StatesThe United Stated cosmetics industry has a market of over $20 billionE...

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Exporting and Selling Cosmetic Products in the United States

FDA – Best Importing Practices for Food in the United States

The sale of food products in the United States is subject to approval by the Food and Drug Administration (FDA)FDA registration, certification servic...

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FDA – Best Importing Practices for Food in the United States

Establishing a Corporation in the United States

Establishing a corporation in the United States is fast and inexpensiveEstablishing a corporation in the United States mitigates the risks of companie...

Establishing a Corporation in the United States
Establishing a Corporation in the United States

Search for Importers, Agents, Sales Representatives, Distributors

To sell in the United States, trade fairs are not enough - a sales network is also needed ExportUSA locates the best fitting business agents, importer...

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Search for Importers, Agents, Sales Representatives, Distributors

Consulting for Exporting to the United States

Consulting for Exporting to the United StatesExportUSA has expertise and experience to help your company export to the United StatesExportUSA's consul...

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Consulting for Exporting to the United States

Marketing and Advertising Campaigns in the United States

ExportUSA, in New York City, is your advertising agency for the United States We create marketing plans and advertising campaigns in the United States...

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Marketing and Advertising Campaigns in the United States

Sales and representative office in the United States

Maintaining an ongoing presence on the market is another key element to sell in the United StatesA sales office for the United States at ExportUSA add...

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Sales and representative office in the United States

Market research in the United States

ExportUSA carries out quantitative and qualitative market surveys and focus groups in the United StatesWe cover all the industries: from consumer pro...

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Market research in the United States

Online selling through Ecommerce in the United States

Online sales is now an established practice in the United States. Many websites addressed to distributors or retailers have now an ecommerce section E...

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Online selling through Ecommerce in the United States

Legal advice in the United States

Solve legal issues in the United States without wasting timeSeek legal advice from the certified lawyers selected by ExportUSA in the United StatesLeg...

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Legal advice in the United States

Procedures for United States B1 – E2 visas

Establishment of a corporation under US law is the first step to apply for B1 and E2 business and investor visas Investors and partners of a U.S. comp...

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Procedures for United States B1 – E2 visas

Logistic services for the United States

US retailers request the goods to be forwarded from a storehouse located in the United StatesExportUSA provides you with efficient, cost-competitive l...

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Logistic services for the United States

Opening - Renting an office in the United States

Renting offices in the United States at affordable ratesEquipped offices in cities, such as New York or Los Angeles, and anywhere else in the United S...

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Opening - Renting an office in the United States

Search for sales managers in the United States

A part-time sales manager in the United States is the cheapest and most efficient way to manage the sales networkA part-time sales manager pays back t...

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Search for sales managers in the United States

Tax and accounting advice in the United States

Expert tax and accounting advice in the United States Consult the certified professional accountants selected by ExportUSA Tax and Accounting Assistan...

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Tax and accounting advice in the United States

Organization trade shows and events in the United States

Organization of trade fairs or events needs to be prepared beforehand if you want US importers to visit your stand Attending a trade fair and just hop...

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Organization trade shows and events in the United States

FDA Medical Devices United States

Exporting and selling medical devices into the United States of America If you want to sell medical devices in America, you need to obtain FDA approva...

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FDA Medical Devices United States

Professional and Personal Fashion and Merchandising Consulting Services

ExportUSA now offers fashion and merchandising consulting services for the United StatesLet ExportUSA help reinvent your business or personal style wi...

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Professional and Personal Fashion and Merchandising Consulting Services