Multi-region, US FDA vs EU CE-mark MDR 2017/745 vs AU TGA. How does the multi-store work?
Three distinct regulatory regimes, three distinct catalogs, one Magento.
US FDA (21 CFR Part 820 quality system, FDA registration + 510(k) for Class II devices): products tagged with FDA registration number, 510(k) reference, Class I/II/III, predicate device. US store view in USD, ships with US HCPCS coding + DME billing handoff.
EU CE-mark under MDR 2017/745 (in force since May 2021, MDR transition extended to 2027/2028 for some classes): products tagged with CE certificate number, Notified Body ID (e.g. NB 0123 for TÜV SÜD), EUDAMED registration number, Basic UDI-DI. Different product attribute set than US. EU store view per locale (DE, FR, NL, IT) in EUR with VAT-included prices. EU customers see CE-marked SKUs only; FDA-only SKUs are hidden via attribute-driven catalog rules.
AU TGA (Therapeutic Goods Administration, ARTG listing required): products tagged with ARTG ID, sponsor name (the AU-registered entity). AU store view in AUD with GST. Most US-class-II devices need separate TGA conformity assessment.
Magento architecture: one product master, multiple website + store-view scopes. Each region’s catalog is filtered by attribute (fda_listed = 1, ce_marked = 1, artg_listed = 1) so a SKU shows up only in the regions where it’s legally sellable. Multi-source inventory (MSI) per warehouse: US warehouse for US store, EU warehouse for EU store, etc. Customer geo-routes via Cloudflare to the right store-view.
Shopify Markets handles the price-display side but cannot cleanly hide a SKU from one market based on regulatory class, Magento can.