The First Step to Enter the U.S. Market: Starting with FDA Compliance

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

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

I. Core Services We Provide

01｜FDA Establishment Registration (Required)

Applicable to food factories, medical device companies, cosmetics enterprises, food contact material manufacturers, etc.

• Establishment/Factory FDA Registration

• DUNS Code Application and Filing

• Agent Services (U.S. Agent)

• Annual Renewal Reminders and Maintenance

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

Applicable to Class I, II, III Medical Devices:

• Medical Device Classification Determination

• Class I Exempt/Non-exempt Registration

• Class II Product 510(k) Technical Documentation Preparation

• Premarket Listing (Device Listing)

• Labeling/Instructions Compliance Review

03｜Food, Food Additive Related FDA Registration

• Food Facility Registration (FFR)

• Food Additive Petition

• Food Contact Material (Plastics, Silicone, Metal, Coatings, etc.) FDA 21 CFR Testing

• Label Compliance Review (Nutritional Label, Ingredients)

04｜Cosmetics MoCRA Registration (Mandatory from 2024)

• Facility Registration

• Product Listing (CPR) Filing

• Formulation Safety Review

• Microbiological, Heavy Metal Testing, etc.

• Label Compliance Review

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

Applicable to Kitchenware, Plastics, Rubber, Silicone, Metal, Ceramics, Paper Products, etc.:

• Migration Testing

• Material Safety Testing

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

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

Matching test standards according to product categories:

• 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｜Role of FDA Registration:

• Prerequisite for legal entry into the U.S. market

• Avoid customs detention and rejection

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

• Enhance product credibility and professional image

02｜Role of FDA Testing:

• Demonstrate product compliance with FDA regulations

• Reduce product safety and compliance risks

• Meet factory audits, bidding, export requirements

III. FDA Application Process

• Product classification confirmation → Determine if under FDA jurisdiction

• Determine registration type → Medical Device/Food/Cosmetics/FCM

• Documentation 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

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

• Multi-disciplinary Team Support in Medical, Food, Cosmetics, and Materials

Includes legal, technical, and standard engineers.

• One-stop Solution

Registration + Testing + Formulation Review + Label Compliance + Technical Consultation.

• Efficient Turnaround, Transparent Pricing

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

Ensure Your Products Enter the U.S. Market Smoothly—Start with FDA Compliance

We are committed to helping businesses overcome regulatory barriers in the U.S. market, reduce compliance risks, and ensure your products reach the world compliantly and steadily.