Explore the medical device requirements currently available for Hong Kong, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Fixed Term Voluntary Listing
MDACS device listing is voluntary and 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 renewal may not be processed and the device may be delisted.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
LRP submits renewal at least 12 weeks and not more than 1 year 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?
Major changes require prior approval; minor changes are notified.
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?
MDIS Takeover Application
No If Takeover Approved
MDIS expressly supports takeover, distinct from ordinary change and renewal.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
