China legal tool China law National framework

China Medical Device
UDI Traceability Assessor

Interactive China legal orientation tool. Review the result with the relevant legal guide and qualified counsel where facts or local implementation matter.

Legal assessmentPRC lawAssumption-led estimate

01Enter facts
02Get estimate
03Check assumptions
04Verify or escalate

Compliance screen

Product is correctly mapped to the current NMPA UDI implementation batch/category?

Device Identifier (DI) assigned under an approved issuing-agency standard?

Production Identifier (PI) elements are encoded where required for the product?

UDI is applied to required packaging levels and remains readable throughout distribution/use?

NMPA UDI database information is submitted/updated before market supply as required?

Legal basis

Scope

UDI implementation has been phased by product category and risk; not every Class II device entered the regime on the same date.

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.

Read China legal guides Find qualified counsel ↗