CBP looks at design specificity and intended use: instruments engineered exclusively for surgical or medical procedures — with sterile packaging, medical-grade materials, and clinical labeling — are classified under medical instrument HTS provisions. General-purpose cutting or gripping tools that happen to be used in a medical setting may instead fall under hand-tool chapters. A binding ruling is advisable for borderline products.

Foreign manufacturers must be registered with FDA and have their devices listed. Most surgical instruments are Class II devices requiring 510(k) clearance demonstrating substantial equivalence to a predicate device. Manufacturers are also expected to operate under a quality management system consistent with ISO 13485, which FDA recognizes as aligned with its Quality System Regulation.