entering the United States.Medical deviceThe market is a complex process involving many regulations and processes. but as long as strictly comply with the FDA requirements and are well prepared, it is likely to succeed.Export to the United StatesMarket detailed steps and concerns.

In the United States, regulation of medical devices is carried out by the Food and Drug Administration (FDA). Any medical device intended to be sold in the United States must comply with FDA regulatory requirements. This requirement is to ensure the safety and effectiveness of the device and to reduce the risks posed to patients or users.

1 Classification based on risk

The FDA divides medical devices into three main categories:Classes I, II, III. These classifications are based on the risks the device poses to patients or users.There are the lowest risks in Class I and the highest risks in Class III.

Class I is:These are mainly some everyday medical devices, such as toothbrush, toothbrush, etc. Most of these products can be sold directly on the market without additional review.
and Class II:Such products are of moderate risk, such as blood sugar monitoring equipment, surgical insulation clothing, etc. They need to apply for 510K for review.
and Class III:This is the highest-risk category, such as surgical lasers, artificial hearts, etc. These products require more rigorous review and testing.

2 Classification based on purpose

The FDA divides it into 16 categories according to the use of medical devices, covering 6,000 product codes. Each product code corresponds to a MDL number, which is a necessary condition for the product to be sold in the U.S. market.

Determination of product classification:First, need to clarify which category of their products are in the FDA. This can be determined through the FDA’s official website or related resources.
Factory registration and listing of medical devices:Under 21CFR part 807.40(a), all medical devices exported to the United States must complete this step.
Designation of U.S. agents:Under Rule 807.40(b), non-U.S. medical device manufacturers are required to designate a U.S. agent to assist in communications and other related matters with the FDA.