The First Step to Entering the U.S. Market Begins with FDA Compliance

The U.S. market is known for its "high entry barriers and high trust." Whether you're a factory, cross-border brand, or trader, as long as your products are planned for sale in the United States, they must comply with FDA (U.S. Food and Drug Administration) regulatory requirements.

Completing FDA registration + FDA testing is a critical step to ensure legal market entry for your products.

I. Core Services We Provide

01｜FDA Establishment Registration (Required)

Applies to food factories, medical device companies, cosmetic companies, food contact material manufacturers, etc.

Factory/Facility FDA Registration

DUNS Number Application and Filing

U.S. Agent Service

Annual Renewal Reminder and Maintenance

02｜FDA Medical Device Registration/Listing/510(k)

Applies to Class I, II, and III medical devices:

Medical Device Product Classification Determination

Class I Exempt/Non-exempt Registration

Class II Product 510(k) Technical File Preparation

Premarket Listing (Listing)

Label/Instruction Manual Compliance Review

03｜Food, Food Additive Related FDA Registration

Food Facility Registration (FF&FR)

Food Additive Notification

Packaging Material (plastic, silicone, metal, coatings, etc.) Food-Grade FDA 21 CFR Testing

Label Compliance Review (Nutritional Label, Ingredients)

04｜Cosmetic MoCRA Registration (Mandatory from 2024)

Facility Registration

Product Listing (CPR) Filing

Formula Safety Review

Microbiological, Heavy Metal Testing

Label Compliance Review

05｜FDA Food Contact Material (FCM) Testing - 21 CFR

Applies to kitchenware, plastic, rubber, silicone, metal, ceramic, paper products, etc.:

Migration Testing

Material Safety Testing

Special Testing (e.g., BPA, Heavy Metals, Additive Analysis)

06｜Medical Device Safety and Performance Testing (FDA Recognized Standards)

Test standards matched according to product category:

ISO 10993 Biocompatibility

Electrical Safety UL/IEC 60601

Material Performance ASTM Series

Sterilization Validation

Package Integrity & Aging Validation

II. Why FDA Registration and Testing are Essential

01｜Function of FDA Registration:

Prerequisite for legal entry into the U.S. market

Avoid customs detention and return

Meet compliance requirements of U.S. distributors and e-commerce platforms

Enhance product credibility and professional image

02｜Function of FDA Testing:

Demonstrate product compliance with FDA regulations

Reduce product safety risks and compliance risks

Meet customer needs for factory audits, bidding, and export

III. FDA Application Process

Product classification confirmation → Determine if subject to FDA jurisdiction

Determine registration type → Medical Device/Food/Cosmetic/FCM

Document preparation and label review

Sample testing (if applicable)

Submit FDA system registration/510(k) application

Obtain FDA registration number/listing number/receipt

Our Advantages

15+ years of professional testing and certification experience

Deep expertise in FDA, CE, EAC, and other third-party testing fields.

Multidisciplinary team support in medical, food, cosmetics, and materials

Includes legal, technical, and standards engineers.

One-stop solution

Registration + Testing + Formula Review + Label Compliance + Technical Consulting.

Efficient timelines, transparent pricing

Suitable for factories, brand owners, and trading companies in various export scenarios.

Ensure Your Product Enters the U.S. Market Smoothly, Starting with FDA Compliance

We are committed to helping companies overcome regulatory barriers in the U.S. market, reduce compliance risks, and ensure your products enter the global market compliantly and stably.