US market entry assessments for two South African exporters

The challenge

Two South African companies were considering the US market through a representation partner. One makes premium leather bags. The other makes medical devices, including a reloadable auto-injector.

Before committing money or signing a representation agreement, they needed to know what entry would really involve: duties, regulation, where they'd sit against US competitors, and whether the margins still worked once every cost was counted.

What we covered

• Customs and duties. Tariff classification, standard duty rates, and eligibility for duty-free entry under AGOA, including the origin and documentation rules.
• Regulation and labelling. FDA 510(k) pathways and timelines for the medical devices, the FTC leather guides for the bags, and California Proposition 65 labelling for both.
• Competitive landscape. Market size and growth, named competitors by price tier, and a recommended price band for each product.
• Margin simulations. Side-by-side models for holding stock in the US versus shipping on demand, and for direct-to-consumer, wholesale and partnership routes.
• Channel options. Marketplaces, wholesale, trade shows, pharmacies, hospital networks and licensing partners, each with its trade-offs.
• Risk register and next steps. Trade policy, currency, regulatory delay, insurer barriers and fulfilment risk, with clear next steps for each company.

Results

Both companies could weigh US representation on real numbers rather than optimism. Each assessment ended with the specific next steps, such as confirming production costs or starting an FDA pre-submission, needed before committing.