Explore the medical device requirements currently available for Taiwan, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Fixed Term
Medical-device licence generally follows a 5-year term; QMS compliance letter is a separate 3-year clock.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Expired licence cannot support ordinary marketing and may require a new application.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Apply for licence extension within 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?
Product name, label, materials/structure/spec/model, efficacy/use, manufacturer, site/country and licence holder have explicit change routes.
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?
Marketing Authorization Holder Or Registrant
Taiwan medical-device licence holder
yes
Local Licence Holder
Often Same Or Named Importer
May Be Separate
allowed
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Joint Licence Holder Transfer
No If Transfer Approved
Holder transfer is expressly listed and requires coordinated old/new/manufacturer evidence.
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 on smallest sales unit and Chinese instructions; importer details included
Chinese
Verified Official
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
