Fizza Surgical exports premium surgical instruments from Sialkot, Pakistan to US hospitals, distributors, Group Purchasing Organizations (GPOs), and ambulatory surgical centers. Our instruments meet FDA Class I requirements for most general surgical instruments and are manufactured under ISO 13485:2016 quality management with CE marking.

Products Available for US Import

FDA Regulatory Pathway for US Import

Most Fizza Surgical instruments fall under FDA Class I — General Controls (21 CFR Part 880 for general surgical instruments), which are 510(k)-exempt. The manufacturer must be registered with FDA and devices must be listed. As the US importer, your company acts as the FDA-registered importer and assumes responsibility for compliance. We provide all manufacturer-level documentation (ISO 13485 certificate, CE Declaration of Conformity, material certificates) to support your import registration.

Shipping to the United States

We ship via DHL Express from Sialkot, Pakistan to any US destination — typically 5–7 business days door-to-door. Large orders can be shipped via air freight through major cargo carriers. We provide full commercial invoices, packing lists, and certificates of origin (Form A / GSP) — note that Pakistan is a US GSP beneficiary for most HS 9018.90 instrument categories, meaning 0% import duty for many instrument types.

Pricing and MOQ

Factory-direct pricing, 30–50% below US distributor prices. Minimum order: 10 pieces per instrument item. Full procedure sets available with MOQ of 1 set. Sample orders accepted for quality evaluation.