TechLink International LLC
TechLink International provides essential FDA compliance services, including US Agent representation, Initial Importer services, and Registration & Listing for medical devices and cosmetics. They ensure efficient communication with the FDA and help foreign establishments navigate US import regulatio
TechLink International LLC specializes in guiding foreign establishments through the complexities of FDA compliance for importing products into the United States. They offer crucial services such as acting as the US Agent, which involves efficient communication with the FDA, and serving as the Initial Importer, a requirement for the release of medical devices. Their expertise extends to Establishment Registrations and Product Listings for medical devices, as well as compliance with the Modernization of Cosmetics Regulation Act (MoCRA), including handling adverse event reporting and assisting with record access. TechLink International acts as a vital liaison, ensuring foreign manufacturers meet all legal obligations and facilitating smooth market entry. As a US Agent, TechLink International is authorized to receive legal notifications and official documents on behalf of manufacturers or importers. They are committed to preventing penalties and fines by ensuring adherence to FDA regulations, thereby safeguarding market access and avoiding product recalls. Their services are designed to streamline the import process and ensure continuous compliance with US regulatory requirements.
About
**Who they are**
TechLink International LLC provides FDA compliance services, including US Agent representation, Initial Importer services, and Registration & Listing for medical devices and cosmetics. They focus on ensuring efficient communication with the FDA for foreign establishments navigating US import regulations.
**Expertise & scope**
* US Agent representation for foreign manufacturers required during Establishment Registration.
* Serving as the official correspondent to communicate efficiently with the FDA.
* Assisting the FDA in communications with foreign establishments.
* Responding to FDA inquiries concerning foreign establishment's devices imported into the United States.
* Assisting the FDA in scheduling inspections of foreign establishments.
* Providing Initial Importer services.
* Offering Registration & Listing services for medical devices.
* Providing services for Cosmetics MoCRA.
* Acting as an FCC Representative.
**Reputation / proof points**
* Operating since at least 2010, as indicated by copyright information.
TechLink International LLC provides FDA compliance services, including US Agent representation, Initial Importer services, and Registration & Listing for medical devices and cosmetics. They focus on ensuring efficient communication with the FDA for foreign establishments navigating US import regulations.
**Expertise & scope**
* US Agent representation for foreign manufacturers required during Establishment Registration.
* Serving as the official correspondent to communicate efficiently with the FDA.
* Assisting the FDA in communications with foreign establishments.
* Responding to FDA inquiries concerning foreign establishment's devices imported into the United States.
* Assisting the FDA in scheduling inspections of foreign establishments.
* Providing Initial Importer services.
* Offering Registration & Listing services for medical devices.
* Providing services for Cosmetics MoCRA.
* Acting as an FCC Representative.
**Reputation / proof points**
* Operating since at least 2010, as indicated by copyright information.
Additional information
TechLink International emphasizes that a US Agent must be a person or legal entity residing or maintaining a place of business in the United States. They cannot use a Post Office Box or an answering service as their address. The US Agent must be available during business hours to answer phone calls. TechLink International positions itself as a qualified expert team ready to work with regulatory authorities to solve problems, ensure compliance, and file required documentation accurately and in a timely manner for importers of FDA-regulated products.
Key Highlights
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Provides US Agent representation, Initial Importer services, and Registration & Listing for medical devices and cosmetics.
Source
“TechLink International provides essential FDA compliance services, including US Agent representation, Initial Importer services, and Registration & Listing for medical devices and cosmetics.”
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Ensures efficient communication with the FDA and helps foreign establishments navigate US import regulations.
Source
“They ensure efficient communication with the FDA and help foreign establishments navigate US import regulatio”
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Acts as a legal entity or person to efficiently communicate with the FDA on behalf of foreign manufacturers.
Source
“Generally speaking, the US Agent is a legal entity or a person in a position to communicate efficiently with the FDA.”
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Assists FDA in communications, responding to questions, and scheduling inspections for foreign establishments.
Source
“Assisting the FDA in communications with the foreign establishment, Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States, Assisting the FDA in scheduling inspections of the foreign establishment,”
Certifications & Trust Signals
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Operating since at least 2010, indicated by copyright information.
Source
“Copyright ©2010-2025 TechLink International. All Rights Reserved.”
Buyer Snapshot
Best for
- Foreign manufacturers requiring US Agent representation.
- Companies needing assistance with FDA establishment registration and listing.
- Businesses seeking support for medical device and cosmetic compliance.
How engagement typically works
- Direct communication and problem-solving with regulatory authorities.
- Proactive assistance with FDA inquiries and inspections.
- Tailored service packages based on client needs.
Typical deliverables
- US Agent designation and communication facilitation.
- FDA Establishment Registration and Device Listing support.
- Adverse event reporting and consumer call handling.
- Guidance on MoCRA compliance for cosmetics.
Good to know
- Best when requiring a dedicated US-based point of contact for FDA interactions.
HQ:
US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Annual Renewal Support:
Yes
Registration Support:
Yes
Inspection Support:
Yes
Product Type:
devices
Additional us_agent_fda Details
Product Types
Medical devices, Cosmetics
Registration Support
Yes
Recall Support
Yes
Inspection Support
Yes
Emergency Contact24x7
No
