By Richie Lin    Photo：CANVA

In 2024, the U.S. medical devices market was valued at about US$180.02–190 billion, while another source estimated US$256.2 billion (a broader category including U.S. manufacturers) 【Fortune Business Insights】. Market size is projected to grow to around US$314.96 billion by 2032, at a 6–7% CAGR. For U.S. food & agricultural imports, the country imported about US$214.1 billion in 2024, spanning fresh produce, processed foods, meats, dairy, beverages, and more. Given the scale of these markets, many global companies continue to seek entry into the United States. However, before launching any marketing or sales campaigns, FDA approvals and compliance roles must be clearly understood. The FDA (U.S. Food and Drug Administration)—a federal agency under the U.S. Department of Health and Human Services—protects public health by ensuring the safety, effectiveness, and quality of food, drugs, and medical products. Within FDA regulations, two compliance roles are critical: Initial Importer (for medical devices) and FSVP Importer (for food products). Most important of all, both must have a U.S. physical address. Once FDA approvals are secured, the Importer of Record (IOR) takes charge of customs clearance and distribution. Although these roles sometimes overlap, they serve distinct legal and compliance functions. In summary, Initial Importer and FSVP Importer play the roles of ensuring products can meet FDA regulations, while Importer of Record is responsible for import customs clearance, paying duties, and distributing products.

1. Initial Importer

• Who it is: A term specific to FDA-regulated products (medical devices, drugs). Defined by the FDA as the first U.S. entity that takes imported products from abroad and distributes them in the U.S.
• Responsibilities:
  • Must register with FDA as an initial importer (for medical devices).
  • Ensure labeling, storage, complaint handling, and reporting compliance.
  • Not necessarily responsible for customs entry duties (that’s the IOR).
• Scope: FDA / product safety focused.

2. FSVP Importer (Foreign Supplier Verification Program)

• Who it is: A U.S. entity responsible under FSMA (Food Safety Modernization Act) for verifying that foreign food suppliers produce food meeting U.S. safety standards.
• Responsibilities:
  • Develop, maintain, and follow an FSVP (hazard analysis, supplier verification, corrective actions).
  • Must be a U.S.-based entity (cannot be a foreign company).
  • Identified on entry documents with FDA.
  • Liable if food is unsafe or non-compliant.
• Scope: FDA / food safety focused.

3. Importer of Record (IOR)

• Who it is: The legal entity or individual responsible to Customs (CBP in the U.S.) for the imported goods.
• Responsibilities:
  • Files import entry paperwork.
  • Pays duties, tariffs, and taxes.
  • Ensures customs compliance (HTS classification, valuation, admissibility, recordkeeping).
  • Liable for penalties if any false declarations.
• Scope: Customs and tariff focused.

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