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Importing medical devices


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The three classes you should know when importing medical devices.

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Importing medical devices

  1. 1. *Postmarket Surveillance (PMS) Used to monitor the safety of a drug or medical device after it has been released on the market. Can further verify or deny the safety after it is used by large numbers of people with a broad variety of medical conditions. References: U.S. Food and Drug Administration. (n.d.). Retrieved July 07, 2015, from FDA - Summary of regulations of Food and Drug Administration rules for suppliers of Healthcare equipment. (n.d.). Retrieved from Accounting per class Class I 55% Class II 40% Class III 5% General Control with Special Conditions If they are found to be faulty may result in harm to the users. Must conform to special control and some are except for the premarket notifications. Special controls include labeling requirements, performance standards and postmarket surveillance.* Designed to perform as indicated without causing injury or harm to the user. General Controls, Special Controls, and Premarket Approval Requires premarket approval, a scientific overview to ensure the safety and usefulness, and have the general controls of class I. Not enough information to assure safety and usefulness through the general or special controls for class I or class II. Usually supports or prolongs human life. Could present an unnecessary risk of illness or injury. AFC International has highly trained and knowledgeable staff to handle your international shipping imports bound for the USA. To learn more about importing medical supplies be sure to visit our blog at: AFC International 1.800.274.2329 @afc_customs custombrokerage@ Question: Am I required to track imported devices? Answer: Yes. An initial importer distributor assumes the role of a domestic manufacturer and, therefore, must track the device throughout its distribution in the U.S. All imports, even if just into customs warehouses, are considered to be “in U.S. commerce” and subject to FDA jurisdiction. Classes You Should Know The FDA recognizes three classes of medical devices. Based on the level of control necessary to secure safety and effectiveness. FDA reported a 3 month review time for applications General Control Class I medical devices may enter the US by making sure the labeling complies with FDA regulations. Not intended to support or prolong life. May not present an unreasonable risk of illness or injury The FDA and U.S. customs border protection work together to determine the legal status of FDA regulated imports. 150 250 Motorized Wheelchairs Infusion Pumps Surgical Drapes Examples Bandages Examination Gloves Hand-held Surgical Instruments Examples Implantable Pacemaker HIV Diagnostic Tests Automated External Defibrillators. Examples Risk Level: Low Risk Level: Medium Risk Level: High