Medical devices exported to the United States why the need for FDA registration

The U.S. Food and Drug Administration (Food and Drug Administration) is referred to as the FDA, FDA is the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public **** Health (PHS) in the establishment of one of the executive agencies. As a scientific regulatory agency, the FDA is responsible for ensuring the safety of food, cosmetics, drugs, biologicals, medical devices, and radiological products manufactured in or imported into the United States. In other words, food, cosmetics, drugs, biologics, medical devices and radiological products sold in the U.S. must be registered and approved by the FDA.

The U.S. FDA requires that foreign medical devices, food, alcohol, drugs and other plants must be registered before entering the U.S. At the same time, it must designate a U.S. agent, who is responsible for emergencies and day-to-day exchanges of business. A U.S. agent is a person who is in the U.S. or has a business location in the U.S., and whom a foreign factory has designated as a registered agent for the purpose of FDA registration. A U.S. agent cannot be just a mailbox, voice telephone number, or a place where the personal address of the person acting as the agent of the foreign plant does not exist at all.

The U.S. agent serves as a communication link between FDA and the foreign plant for emergencies and day-to-day communications. When an emergency occurs, FDA contacts the U.S. agent unless another is designated as the emergency contact at the time of registration.

The U.S. Agent represents the foreign facility, and FDA will consider statements made by the U.S. Agent to be statements made by the foreign facility and will consider information or documents provided to the U.S. Agent to be the same as if the information or documents had been provided to the foreign facility.

A manufacturer may designate only one person as its U.S. agent for purposes of FDA plant registration, and the designation of a U.S. agent for the purpose of plant registration does not preclude a plant from designating more than one other agent for the purpose of carrying out other commercial activities (e.g., foreign suppliers). Commercial activities conducted by a company in the United States do not need to be conducted through an agent designated for this registration.

Step 1: Determine Product Classification

Most medical devices in accordance with CFR TITLE 21 Parts 862-892 can be classified under this classification code.FDA Classification Codes?

Step 2: Select a U.S. Agent (US AGENT)

Step 3: Registration Preparation

Class 1 products are directly factory registered and product listed; Class 2 products require preparation of a 510(k) document.

Step 4: Submission of 510(k) document to FDA for document review

Step 5: Factory registration and product listing