Authorized Rep Services for TEMU | EU, UK, US

To sell products on overseas platforms such as TEMU, it is necessary to provide authorized representative documentation for each country. Notably, following TEMU’s requirement for a Turkish Authorized Representative (“Turkey Rep”), AliExpress has also recently announced similar requirements for Turkish representation.

This article provides a detailed overview of authorized representatives in various countries, including the European Union, United States, United Kingdom, Canada, Australia, and other major markets, helping businesses efficiently meet compliance requirements.

1. What Is an Authorized Representative?

An Authorized Representative (AR) is a legal entity designated by the manufacturer in the target market country/region to fULfill regulatory obligations on behalf of the manufacturer. Key responsibilities include:

1. Assisting with product registration and filing

2. Maintaining technical documentation for inspection by regulatory authorities

3. Handling adverse event reports and product recalls

4. Communicating with local regulatory agencies

2. Which Products Require an Authorized Representative?

Not all products require an authorized representative, but the following industries typically do:

1. Medical Devices (EU MDR, US FDA, China NMPA, etc.)

2. Cosmetics (EU CPNP, US FDA, South Korea MFDS, etc.)

3. Electronic Products (EU CE-RED, US FCC, Korea KC, etc.)

4. Children’s products, food contact materials, cheMICals, etc.

3. Applicable Regulations for Authorized Representatives in Major Countries

eu authorized representative (EC REP)

Applicable Regulations:

1. Medical Devices (MDR/IVDR)

2. Cosmetics (CPNP)

3. Electronic Products (CE-RED, LVD, EMC, etc.)

> Note: A separate UK Authorized Representative (UKRP) is required post-Brexit.

US Authorized Representative (U.S. Agent)

Applicable Regulations:

1. Medical Devices (FDA 21 CFR 807)

2. Cosmetics (FDA Voluntary Cosmetic Registration Program, VCRP)

3. Food and Drugs: 21 CFR 1.227 (U.S. Agent requirement)

Turkey Authorized Representative (Türkiye Yetkili Temsilci)

Applicable Regulations:

1. Medical Devices (TITCK)

2. Electronic Products (TSE)

3. Cosmetics, etc.

Canada Authorized Representative (Canadian Rep, CR)

Applicable Regulations:

1. Medical Devices (SOR/98-282)

2. Electronic Products (ised certification)

Australia Authorized Representative (Australian Sponsor)

Applicable Regulations:

1. Medical Devices (TGA)

2. Radiocommunications Act 1992

3. Cosmetics, food products, etc.

4. Key Considerations When Selecting an Authorized Representative

a. Credential Verification: Confirm legal registration in the target country

b. Professional Competence: Familiarity with relevant regulatory requirements

c. Service Scope: Includes registration, document management, incident reporting, etc.

d. Response Efficiency: Ability to promptly respond to inquiries and inspections

e. Fee Structure: Clearly define one-time and annual maintenance costs

5. Frequently Asked Questions

Q: Is the authorized representative liable for the product?

A: In most jurisdictions, the manufacturer retains responsibility for product quality, but the AR shares certain compliance obligations.

Q: Is it complicated to change an authorized representative?

A: The process varies by country, usually requiring notification to authorities and updates to registration info, sometimes with a transition period.

Q: Is an authorized representative required for e-commerce platform sales?

A: Many platforms (such as TEMU, Amazon, etc.) require AR information to verify product compliance.

Appointing authorized representatives in key countries is a critical compliance step for global product distribution. Choosing the right representative helps companies enter target markets efficiently and minimize legal risks.

If you need authorized representative services for the EU, US, UK, Canada, Australia, Turkey, and other markets, feel free to contact us—we provide one-stop global market access solutions!