Medical Devices

FDA defines a medical device as an instrument, machines, implants, in vitro reagents, and similar or related articles, including component parts or accessories which are:

1

Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or

2

Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Medical devices fall into one of three classes.

Class 1

Class 1 medical devices are those with the lowest level of risk associated with them. If a Class 1 medical device failed or became defective, there would be no significant injury or harm to the patient or user.

Class 2

Class 2 medical devices carry greater risk. If a Class 2 medical device failed or became defective, there would be a risk that the patient or the user could be injured or harmed. Typically a 510(k) application is required.

Class 3

Class 3 medical devices carry the greatest risk. If a Class 3 medical device failed or became defective, there would be a risk of serious injury or death to the patient or the user. Typically a Pre-Market Approval (PMA) is required.

In order to import any class of medical device into the U.S. the manufacturer, exporter (if not the manufacturer), and initial importer must all be registered with the FDA and the device must be listed with the FDA. Diaz Trade Consulting assists with facility registrations and device listing services.

Medical Devices

1

2

Class 1

Class 2

Class 3

Register Your Medical Device Facility today.

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