The three classes you should know when importing medical devices.

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
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
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