Regulator Comparison
Side-by-side comparisons of major medical device regulatory pathways — curated for RA teams planning multi-market registration.
Compare FDA 510(k)/PMA with EU MDR CE marking — classification, timelines, costs, QMS requirements, and post-market obligations side by side.
FDA vs NMPAUnited States vs ChinaSide-by-side comparison of FDA and NMPA medical device registration — classification, CMDE review, MAH requirements, clinical trials, and timelines.
FDA vs PMDAUnited States vs JapanCompare FDA 510(k)/PMA with PMDA Shonin/Ninsho — classification, QMS (Ordinance 169 vs 21 CFR 820), clinical data requirements, and DMAL holder vs US Agent.
EMA vs NMPAEuropean Union vs ChinaCompare EU MDR CE marking with NMPA registration — Notified Bodies vs CMDE, UDI requirements, clinical evidence, and post-market surveillance.
FDA vs TGAUnited States vs AustraliaCompare FDA and TGA medical device pathways — ARTG registration, MDSAP recognition, classification differences, and post-market requirements.
FDA vs Health CanadaUnited States vs CanadaCompare FDA and Health Canada device regulation — MDL vs 510(k), MDSAP single audit, Class IV vs PMA, and cross-border regulatory strategy.
EMA vs MHRAEuropean Union vs United KingdomCompare EU MDR CE marking with UK UKCA marking — diverging requirements, transition deadlines, dual-market strategies, and Notified Body vs UK Approved Body.
FDA vs ANVISAUnited States vs BrazilCompare FDA and ANVISA medical device registration — BRH requirements, MDSAP pathway, INMETRO certification, and Portuguese labeling.
FDA vs CDSCOUnited States vs IndiaCompare FDA and CDSCO medical device pathways — Class A-D vs Class I-III, import license (MD-14), clinical investigation requirements, and Make in India impact.