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Class I Devices
 
Class I devices are devices which pose no risk to the patient (syringes, gloves, beds, etc.). These have to go through a short, rather formal process consisting of the following actions:
  1. Contract with a US Regulatory Designated Agent in the USA.

  2. Register the manufacturer through the Regulatory Designated Agent with the FDA

  3. List the products through the Regulatory Designated Agent with the FDA.
The Regulatory Designated Agent

Companies that import medical devices into the United States need to appoint a Regulatory Designated Agent. The Food and Drug Administration Modernization Act of 1997 (FDAMA) requires that "any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a … device that is imported into the United States shall register with [FDA] the name and place of business of the establishment and the name of the United States agent for the establishment". The role of a U.S. Regulatory Designated Agent under the regulations requires that it be authorized to speak with FDA on behalf of the company, and to discuss proprietary information about the company.

For more information on the Regulatory Designated Agent please go to the Medes USA Inc. website.
 
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