Regulatory markets
Choose the market you are preparing to enter.
Each market has its own classification, evidence, registration and post-market requirements. Select a country or region to see the relevant routes and services.
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United States · FDA
510(k), De Novo, Pre-Sub, QMSR, cybersecurity and AI/ML.
View market requirements →🇪🇺European Union · EU MDR
Rule 11, CE marking, technical documentation, clinical evidence and PMS.
View market requirements →🇨🇦Canada · Health Canada
SaMD classification, MDL and MDEL applications, MDSAP and bilingual labelling.
View market requirements →🇬🇧United Kingdom · MHRA
GB registration, UK Responsible Person, UKCA strategy and post-market duties.
View market requirements →🇮🇳India · CDSCO
SaMD qualification, classification, licensing and post-market duties.
View market requirements →