Explore the medical device requirements currently available for China, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Route Dependent
Class I filing has no ordinary five-year certificate; Class II/III registration certificate is valid 5 years.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Late/non-compliant renewal conditions can require a new application or end marketing authorization.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Class II/III renewal is filed 6 months before expiry.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Substantial design/material/process/scope/use changes possibly affecting safety/effectiveness require change registration; other changes may be filed/reported.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Registration Agent But Foreign Manufacturer Remains Registrant
China domestic agent for overseas registrant
yes
Assists Foreign Registrant Lifecycle Duties
Can Be Separate
Can Be Separate
Allowed But Roles Remain Distinct
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Agent Change Filing
No If Only Agent Change
Beijing's 2026 implementation gives a practical 5-working-day notice and 30-working-day filing sequence; treat it as Beijing-specific until a national operational rule is confirmed.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which label and IFU elements, languages, symbols, and translation controls apply?
Chinese; imported-device label/IFU includes agent details
Chinese application dossier with permitted foreign originals/translations
Verified Official
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
