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Which type of product needs FDA for export

Date:2023-09-22 11:10:19 Classification :【question】 Visits:
The US FDA is an abbreviation for the Food and Drug Administration. It is a regulatory agency of the US federal government responsible for ensuring the safety, effectiveness, and quality of food, drugs, cosmetics, medical devices, and other related products for the public.

The main responsibilities of the FDA include:

1. Food supervision: Ensure the safety of food and the accuracy of labeling information, supervise the production, sales, and import of food.

2. Drug regulation: Evaluate and approve the safety and effectiveness of new drugs, supervise the manufacturing, labeling, and use of drugs.

3. Medical device regulation: Evaluate and approve the safety and effectiveness of medical devices, supervise the manufacturing, labeling, and use of medical devices.

4. Biological Product Regulation: Regulate the safety and quality of biological products, including biopharmaceuticals and blood products.

5. Vaccine regulation: Evaluate and approve the safety and effectiveness of vaccines, supervise the manufacturing, labeling, and use of vaccines.

The FDA's review and regulatory procedures help ensure that new medical technologies have a certain level of safety and effectiveness in human clinical trials, and effectively reduce potential risks and injuries. It also helps to ensure the scientific reliability and consistency of experimental data, in order to better evaluate the effectiveness and potential benefits of new technologies.

The following types of products may require FDA registration:

1. Food: All food exported to the United States (including health food, drinking water, food additives, baby food, etc.);

2. Drugs: raw materials, packaging materials, human vaccines, prescription drugs, over-the-counter drugs, etc;

3. Cosmetics: skincare products, makeup, shampoo, etc;

4. Medical equipment: ventilators, endoscopes, wheelchairs, electronic thermometers, sphygmomanometers, masks, protective clothing, etc;

5. Laser radiation products: microwave ovens, CT, X-ray equipment, etc;

6. Food contact materials: Food contact material components and raw materials (various plastics, metals, ceramics, glass, bamboo and wood products, etc.);

7. Veterinary products: livestock feed, pet food, veterinary medicine, etc.

If your product belongs to the above types, you need to register with the FDA before selling it in the US market or launching it in the domestic market. Registration with FDA can ensure that the quality and safety of these products are certified, thereby improving the export competitiveness of enterprises. At the same time, this also provides consumers with higher quality product choices.

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