Practical Insights for Navigating the U.S. Medical Device Market

Avoiding Channel Lock-In During U.S. Market Entry → Hybrid U.S. Distribution Models: Filling White Space Without Replacing Existing Distributors → When a Strategic Becomes Your Distributor: Protecting Future Exit Optionality → Direct-to-Patient Fulfillment and HIPAA: When a Business Associate Agreement Is Required → Selling to the Federal Government: When State Registration Still Applies → U.S. Subsidiary vs. Branch Operations → When a Foreign Manufacturer May Not Need Its Own U.S. Entity → Obtaining an EIN and Establishing U.S. Admin Infrastructure → Using Independent Contractors in a U.S. Launch → Insurance Readiness Before Clinical or Commercial Activity → Importer of Record vs FDA Initial Importer → What the FDA Initial Importer Is Actually Responsible For → Preparing to Import Medical Devices into the United States → When an Imported Medical Device May Be Detained at the Border → FDA and Customs Have Different Roles at Import → The Role of a Customs Broker in Medical Device Importation → FDA Affirmations of Compliance at Import → Importing Investigational Medical Devices into the United States → Temporary Imports for Trade Shows, Demonstrations, and Evaluation → Customs Clearance Is Not a Guaranteed Delivery Date → Returns, Repairs, and Re-Importation of Medical Devices → Hand-Carrying Medical Devices into the United States → Importing Medical Devices for Non-Clinical Testing in the United States → When U.S. Activities Create Federal Income-Tax Exposure → Permanent Establishment Risk Under U.S. Tax Treaties → U.S. Subsidiary vs. Branch: Income-Tax Considerations → Inventory in the United States and Federal Income-Tax Nexus → U.S. Personnel and Income-Tax Nexus → Transfer Pricing for U.S. Medical Device Operations → How Tax Treaties Affect U.S. Market Entry → No Corporate Income Tax Does Not Mean No Business Tax → Consignment Programs and Income-Tax Nexus → Clinical Studies and U.S. Tax Presence → FDA Establishment Registration Does Not Create a U.S. Legal Entity → Using a U.S. Address Does Not Necessarily Establish a U.S. Presence → When a 3PL Becomes More Than a Logistics Provider → The FDA U.S. Agent: What the Role Is—and Is Not → U.S. Agent vs. Initial Importer vs. Importer of Record → Selecting a U.S. Representative for More Than a Mailing Address → Using Multiple Initial Importers in the United States → Recall and Field-Action Communications Through a U.S. Representative → Representation Agreements: Defining Scope Before Problems Arise → Changing U.S. Agents Without Creating a Communication Gap → Commercial Representation Is Different from Regulatory Representation → When a Medical-Device Distributor Must Register with a State Board of Pharmacy → Prescription, OTC, and 510(k) Status Do Not Determine State Licensing by Themselves → DME Permits and Medical-Device Distributor Licenses Are Not the Same Thing → Direct-to-Patient Fulfillment Can Trigger Additional State Requirements → Practitioner-Only Distribution Exemptions and Their Limits → Virtual Manufacturers, Specification Developers, and State Licensure → Using a 3PL Does Not Automatically Eliminate Licensing Obligations → State Licensing Due Diligence Before Signing a Distribution Agreement → Why Medical Device Distributor Licensing Varies So Widely by State → State Definitions of “Medical Device” Do Not Always Match FDA → Why State Licensing Gaps Matter in Investor and Lender Due Diligence → Sales Tax Nexus for Medical Device Companies → Are Medical Devices Exempt from Sales Tax? → Prescription Device Exemptions and Documentation → Resale Certificates in Distributor and Dealer Channels → Direct-to-Patient Sales and Sales Tax Collection → Consignment Sales and the Point of Taxation → Drop Shipments and Sales Tax Documentation → Managing Exemption Certificates as Controlled Records → If Your Medical Devices Are Sales Tax Exempt, Must You Still Register? → Customs Does Not Collect State Sales Tax: Import Duty, Sales Tax, and Use Tax Are Different → When an Out-of-State Company Must Foreign-Qualify → Foreign Qualification Is Different from Regulatory Licensing → Does Shipping Product into a State Require Foreign Registration? → Inventory Held at a 3PL and Corporate-Nexus Risk → Consignment Inventory and Doing-Business Analysis → Annual Reports, Franchise Fees, and Ongoing State Maintenance → Penalties and Contract Risks of Operating Before Qualification →