CAFTA-DR for Medical Device Manufacturers: Dominican Republic Free Zone Guide

Why the DR Works for Medical Devices

The DR free zone sector produces approximately $1.4 billion annually in medical device exports — mostly U.S.-destined. Over 30 years of free zone operations have produced a workforce experienced in medical device assembly, quality systems, and regulatory documentation. Under Law 8-90, manufacturers receive full income tax exemption, duty-free input imports, and unrestricted capital repatriation.

CAFTA-DR Eligibility for Medical Devices

Devices classified under HTS Chapter 90 qualify for duty-free U.S. entry when the applicable rules of origin are satisfied. Most assembly operations meet the tariff shift requirement — components imported under one HTS classification assembled into a finished device under a different heading. Rules of origin analysis is required for each specific device type. See the CAFTA-DR guide for sector rules.

FDA Registration

DR-manufactured devices exported to the U.S. must comply with FDA foreign establishment registration and device listing requirements. ISO 13485 certification is standard in established DR medical device free zone parks. Class II and III devices require QSR compliance. Established parks have existing FDA-registered infrastructure.

U.S. Hospital Procurement Access

CAFTA-DR origin qualification can satisfy domestic preference requirements in certain U.S. government medical procurement. For Israeli and European manufacturers, this opens procurement channels previously unavailable from non-CAFTA sources. To assess your device category’s eligibility, submit an EGS mandate inquiry.