Which Certifications Require a US Agent?

Recently, U.S. government agencies and major e-commerce platforms such as Amazon have significantly strengthened their compliance review measures for products. Sellers must pay close attention and arrange for a professional U.S. Authorized Representative (US Agent)service as soon as possible to effectively avoid potential risks such as customs detention of goodsor forced product delisting.

Starting April 2025, CPC Certification for Amazon and TEMU listings will mandatorily require a U.S. Authorized Representative!

What Is a U.S. Authorized Representative (US Agent)?

The fULl term is U.S. Authorized Representative.

According to relevant U.S. regulations (FDA, FCC, CPC, etc.), sellers of medical devices, cosmetics, food, drugs, laser products, wireless products, children’s toys, maternity and baby products, and similar goods must complete a registration process before entering the U.S. marketand designate a U.S. Authorized Representative.

Key Responsibilities

The U.S. Authorized Representative is responsible for:

- Handling emergency situationsand routine communicationswith U.S. authorities.

Eligibility Requirements

The representative must:

- Have a physical commercial location within the United States.

- Be able to answer phone calls or receive mail during normal business hours.

> Locations that only provide an email address, voicemail service, or personal residential address do not meet the requirements.

Certifications That Require a U.S. Authorized Representative

1. FDA Certification

Foreign sellers in industries regulated by the FDA must complete FDA registrationand appoint a U.S. Authorized Representative before selling products in the United States. This includes:

- Medical Devices: from simple medical consumables to complex large-scale medical equipment

- Cosmetics: skincare, makeup, haircare products

- Food: fresh food, processed food, beverages

- Drugs: prescription drugs and over-the-counter (OTC) medicines

- Alcohol & Laser Products: products regulated under FDA jurisdiction

2. FCC Certification

Foreign sellers of wireless and communication products that require FCC certification must designate a U.S. Authorized Representative.

Applicable products include:

- WiFi devices

- Bluetooth devices

- Mobile phones

- Computers

- Radio transmission/reception equipment

- Wireless remote-control toys

3. CPC Certification

Products primarily intended for children 12 years old and underrequire a Children’s Product Certificate (CPC).

Examples:

- Toys

- Cradles

- Baby carriers/hip seats

- Children’s clothing

> Non-U.S. manufacturers must appoint a U.S. Authorized Representative and include their information on the CPC certificate.

4. epa certification

Foreign sellers of pesticide products or pesticide-related devices must register an EPA U.S. Authorized Representative.

CoveRED products include:

- Pesticides (insecticides, rodenticides, herbicides, etc.)

- Pesticide devices (UV sterilizers, insect traps, etc.)

5. Energy Label Certification

Products requiring energy labeling, such as:

- Televisions

- Refrigerators

- Freezers

- Washing machines

- Air conditioners

If the manufacturer is located outside the United States, a U.S. Authorized Representative must also be appointed.

Duties of a U.S. Authorized Representative

1. Act as the responsible partyfor products sold in the United States.

2. Assist communicationand liaise with U.S. authorities on behalf of the client.

3. Respond to official inquirieswith the seller’s cooperation.

How to Appoint a U.S. Authorized Representative

Contact China JJR Laboratory

1. Submit application materials.

2. Sign the representative agreement.

3. JJR/LIO will provide the U.S. Authorized Representative information.