Taiwan & the U.S. Market — Why FDA Compliance Matters
Taiwan is one of the United States' most important Asia-Pacific trading partners, with bilateral trade exceeding $150 billion annually. Taiwan is particularly significant as a medical device and precision equipment manufacturer — alongside substantial exports of food products, dietary supplements, and pharmaceuticals to the U.S. market.
Taiwan's TFDA (Taiwan Food and Drug Administration) regulatory approvals do not substitute for U.S. FDA registration. Taiwanese manufacturers must register separately with the FDA and designate a U.S. Agent to legally export FDA-regulated products to the United States.
Important: TFDA approval in Taiwan does not fulfil U.S. FDA requirements. Taiwanese medical device manufacturers, food companies, and pharmaceutical firms must register separately with the FDA and designate a U.S. Agent — regardless of TFDA compliance status.
Which Taiwan Products Require FDA Registration
The following Sri Lankan export categories require FDA registration and a designated U.S. Agent:
Medical Devices & Precision Equipment
Taiwan is a world leader in precision medical device manufacturing — dental equipment, diagnostic devices, surgical instruments, and medical imaging. All Taiwanese device manufacturers require annual CDRH establishment registration, device listing, and U.S. Agent designation. TFDA approval does not substitute for FDA registration.
Food, Processed Foods & Beverages
Taiwanese food manufacturers — including instant foods, condiments, beverages, and specialty snacks — require FDA Food Facility Registration and U.S. Agent designation. The popularity of Taiwanese food products in the U.S. market makes active FDA compliance essential.
Pharmaceuticals & APIs
Taiwanese pharmaceutical manufacturers and API suppliers exporting to the U.S. require CDER drug establishment registration, NDC Labeler Code, and U.S. Agent designation. Annual renewal is mandatory and TFDA approval does not substitute for FDA registration.
Cosmetics & Skincare
Taiwanese cosmetics and skincare brands exporting to the U.S. must comply with MoCRA (2023) — mandatory FDA facility registration, product listing, and U.S.-based Responsible Person designation. Taiwan has a growing beauty and skincare export sector targeting the U.S. market.
The U.S. Agent Requirement for Sri Lankan Exporters
Every Taiwan facility registering with the FDA must designate a U.S. Agent — a person or company physically located in the United States. This is a legal requirement under 21 CFR; without a valid U.S. Agent your FDA registration will be rejected.
The U.S. Agent acts as the FDA's domestic point of contact for your Sri Lankan facility. They receive all official FDA communications on your behalf, assist with inspection coordination, and ensure critical notices reach you in time. Choosing the wrong U.S. Agent is one of the most common and costly mistakes Sri Lankan exporters make.
Regovant LLC is a trusted FDA U.S. Agent for Taiwan exporters, physically based in Casper, Wyoming USA. Learn about our U.S. Agent services →
How to Get FDA Registered as a Sri Lankan Exporter
Identify Your Product Category
Confirm whether your products fall under food, dietary supplement, medical device, drug, or cosmetics — each has different registration requirements and renewal timelines.
Designate a U.S. Agent
Select a physically U.S.-incorporated regulatory firm as your U.S. Agent. This is required before registration can proceed. Ensure they cover your specific product category.
Register in FDA's FURLS System
Your U.S. Agent submits your facility registration through the FDA Unified Registration and Listing System (FURLS). For food facilities, this includes your D-U-N-S number, facility details, and product categories.
Receive Your FEI Number & Certificate
Upon successful registration, the FDA issues your FDA Establishment Identifier (FEI) number. Your U.S. Agent delivers your official Certificate of Registration — the document your U.S. importers will request.
Maintain Compliance & Renew
Food facilities renew every 2 years (odd-numbered years: 2025, 2027). Medical devices, drugs, and cosmetics renew annually. Your U.S. Agent handles renewal reminders and submissions.
FDA Registration Costs for Sri Lankan Companies
The FDA itself charges no government fee for food facility registration, medical device establishment registration, or MoCRA cosmetics registration. The cost you pay goes entirely to your service provider for handling the registration on your behalf.
Regovant's fixed pricing for Sri Lankan exporters:
- Food Facility Registration + U.S. Agent + Certificate: $300/year
- Medical Device Establishment + U.S. Agent + Certificate: $550/year
- Drug Establishment + NDC + U.S. Agent + Certificate: $550/year
- Cosmetic Facility Registration (MoCRA) + Certificate: $650/year
- Additional food facility (same owner): $150/year
Note for Taiwan exporters: Many Taiwan facilities export multiple FDA-regulated product types. Each distinct product category may require separate registration. Regovant can assess your full product range and advise which registrations are actually required.
Why Taiwan Exporters Choose Regovant
Regovant LLC serves Taiwan exporters across multiple FDA product categories. We understand the specific compliance challenges Taiwan manufacturers face when entering the U.S. market.
FDA Registration for Taiwanese Manufacturers — From $300/Year
Regovant handles FDA registration for Taiwanese medical device companies, food exporters, pharmaceutical manufacturers, and cosmetics brands. TFDA approval does not replace FDA registration — Regovant handles the complete U.S.-specific compliance process.