HOW TO IMPORT MEDICAL DEVICES3 CLASSES YOU SHOULD KNOWThe FDA recognizes three classes of medical devices. Based on the level of control necessary to secure safety and eectiveness.

Class I: General ControlClass I medical devices may enter the US by making sure the labeling complies with FDA regulations.Not intended to support life or prolong life.May not present an unreasonable risk of illness or injuryExamples : bandages, examination gloves, and hand-held surgical instruments.STAT: Accounts for 55% of the medical devices

Class II: General Control with Special ConditionsCarry a greater riskIf 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 notications. Special controls include labeling requirements, performance standards and postmarket surveillance.Designed to perform as indicated without causing injury or harm to the user. Examples: motorized wheelchairs, infusion pumps and a surgical drape.STAT: FDA reported review time is 3 months average time elapsed time from receipt to nal decisionSTAT: Class II accounts for 40% of devices

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 conditionsQuestion: 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.

Class III: General Controls, Special Controls, and Premarket ApprovalRequires premarket approval, a scientic 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 lifeCould present an unnecessary risk of illness or injury.Examples include implantable pacemaker, HIV diagnostic tests, and automated external debrillators.STAT: Class III accounts for 5% of the medical devices

All imports, even if just into customs warehouses, are considered to be in U.S. commerce and subject to FDA jurisdiction. The FDA and U.S. Customs Border Protection work together to determine the legal status of FDA regulated imports.

AFC International has highly trained and knowledgeable sta to handle your international shipping imports bound for the USA. We can clear your shipments through any major U.S. port, making the customs clearance process simple and fast. Need assistance with your medical devices contact us at AFC International. U.S. Food and Drug Administration. (n.d.). Retrieved July 07, 2015, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuid-ance/GuidanceDocuments/ucm071756.htmFDA - Summary of regulations of Food and Drug Administration rules for suppliers of Healthcare equipment. (n.d.). Retrieved from http://f-da.dirkjanswagerman.nl/

*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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071756.htm

FDA - Summary of regulations of Food and Drug Administration rules for suppliers of Healthcare equipment. (n.d.). Retrieved from http://fda.dirkjanswagerman.nl/v

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: http://www.afcinternationalllc.com/blog/importing-medical-devices-three-classes-know/

AFC International

1.800.274.2329@afc_customs

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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 KnowThe 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 ControlClass 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.

150250

MotorizedWheelchairs

InfusionPumps

SurgicalDrapes

Examples

Bandages ExaminationGloves

Hand-held Surgical

Instruments

Examples

ImplantablePacemaker

HIV DiagnosticTests

AutomatedExternal

Defibrillators.

Examples

Risk Level:Low

Risk Level: Medium

Risk Level:High