🎯 The concrete business: an export trading company for low-risk (Class I) American medical supplies — exam gloves, instruments, gauze, exam furniture — sold to private-clinic distributors in the UAE, Saudi Arabia, Kenya and Nigeria, where “FDA-grade” is the strongest word in the catalog.
Weeks 1–2: LLC/EIN/bank + product liability insurance quotes (~$1,500/yr). One hour with a regulatory consultant (~$300) to confirm your lane: pure traders of unmodified U.S. devices usually don’t need FDA establishment registration — manufacturers/relabelers do. Get that in writing.
Weeks 3–4: supply: open accounts with 3 U.S. wholesalers/manufacturers (search FDA’s device listing database by product; call the maker, ask “who distributes for export?”). Build a 30-item catalog with FOB prices.
Weeks 5–8: demand: USEAC healthcare specialist + Gold Key in the UAE (embassy finds distributor candidates); email 25 distributors from trade-show exhibitor lists (Arab Health, Medic East Africa). Learn the Certificate to Foreign Government (CFG) — the FDA paper (small fee, apply online) most countries ask for; your manufacturers often already hold them.
Weeks 9–12: first order against an irrevocable letter of credit. Your distributor handles their country’s registration (UAE MOHAP, Kenya PPB, Nigeria NAFDAC) — choose distributors who already hold licenses; that’s your #1 selection question.
| LLC + licenses + insurance | $2,000 |
| Regulatory consult (2 hrs) | $600 |
| Catalog/site + samples | $1,200 |
| Gold Key + Arab Health trip (STEP can refund much of it) | $4,000 |
| Working capital for first mixed pallet | $8,000 |
| Total | ≈ $12,000–16,000 |
1) LLC/EIN → 2) written regulatory opinion on your registration status → 3) per product: confirm it’s listed with FDA (maker’s job) + CFG if the country asks → 4) per shipment: commercial invoice, packing list, certificate of origin; screening list check → 5) destination registration = distributor’s job with your document support. Never touch prescription drugs or Class III devices as a beginner — that’s a different license universe (FDA 801/802 export rules).
1–3: Gold Key UAE meetings. 4–6: Arab Health exhibitor-list outreach. 7–8: Kenyan/Nigerian distributors from Medic East/West Africa lists. 9–10: U.S. medical-mission NGOs (they buy supplies for the same countries and pay upfront).
Gloves/commodities: 5–8% margin (volume game — fill containers). Instruments & exam furniture: 20–40%. A $20,000 mixed pallet at blended 18% = $3,600. Two pallets/month = $7,000+/month gross. NGOs pay list price — best margins of all.
Month 3: 30-item catalog, 3 supplier accounts, 25 distributor contacts. Month 6: first LC-backed pallet. Month 12: 3 repeat distributors in 2 countries; add refurbished equipment line (new rules — revisit consultant). Change-course rule: if distributors love the catalog but not prices, you’re too many middlemen deep — go closer to manufacturers or switch to the NGO channel.
① Overselling claims = federal “misbranding” → quote the manufacturer’s own labeling, never improvise medical claims. ② Cold-chain items → don’t start there. ③ Counterfeit-prone markets → serialized invoices, sell only through licensed distributors. ④ Payment → LC until trust, then EXIM-insured terms.