Explore the medical device requirements currently available for Singapore, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Indefinite With Annual Retention
Registered Class B/C/D devices remain on the Singapore Medical Device Register subject to annual retention and ongoing compliance.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Non-retention or cancellation ends active registration/listing.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Pay annual retention; dealer licences have separate annual renewal.
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?
Administrative, review and technical change-notification routes differ by class.
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?
Marketing Authorization Holder Or Registrant
Singapore registrant
yes
Local Registration Holder
Separate Importer Dealer Licence
Separate Wholesaler Dealer Licence
Allowed If Each Licence Is Held
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
GN24 Change Of Registrant
No If Change Approved
Effective only after HSA approval; the incoming registrant assumes regulatory obligations and system access.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
