SaMD
Software/AI products are classified by intended medical purpose, risk, decision impact and classification catalog/rules—not simply because they are software. Novel products can seek classification determination from NMPA.
China legal tool China law National framework
China Medical Device NMPA Classification & Registration
Pathway Diagnostic
Interactive China legal orientation tool. Review the result with the relevant legal guide and qualified counsel where facts or local implementation matter.
- 01Enter facts
- 02Get estimate
- 03Check assumptions
- 04Verify or escalate
Medical device classification / pathway
Legal authorityReview the legal-basis section and cited source before relying on the output.
Tool typeLegal assessment
ScopeNational framework first
Local checkLocal rules and authority practice may differ
Use the output safely
Verify before relying on the result.
- InputsConfirm dates, amounts, classifications and assumptions.
- AuthorityCheck the cited rule, effective date and territorial scope.
- EscalationSeek review for disputed facts, material exposure or imminent deadlines.
When the file needs review
Move from the tool to a verified legal route.
Use the output to organize the facts, then confirm the source, evidence, local implementation and available remedy before acting.