The free MDACS listing
Zero government fees, 12-week official review (up to 24 months in practice), 5-year validity — filed via an LRP on MDIS.
Free field guide · PDF
Hong Kong MDD Medical Device Listing2026 Field Guide
The free MDACS listing, the 2026 Stage C mandate, and the LRP — with the two pathways to listing.
- Government fees
- FREE
- 23 Mar 2026
- Stage C
- Listing validity
- 5 yrs
Sourced from MDD guidance and verified 2026 publications.
Download the free guide
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — MDD guidance and verified 2026 publications.
Two pathways to listing
CAB conformity assessment or reference-market approvals (8 jurisdictions) — plus the Expedited Approval Scheme for 2+ reference approvals.
The 2026 Stage C mandate
Since 23 March 2026, DH procurement requires an MDACS listing — and Hospital Authority tenders already prefer registered products.
Sources & scope
- asiaactual.com, Hong Kong Medical Device Registration (Sep 2026).
- mdd.gov.hk, official Overview of Hong Kong Medical Device Listing Process.
- qualtechs.com, Hong Kong Mandatory MDACS Listing for DH Medical Device Procurement Stage C.
This guide is market-access intelligence, not regulatory or legal advice. MDD timelines, guidance, and review practice change — professional review is required before business use.
Market Access Strategy Session
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A Market Access Strategy Session maps your MDD route — LRP appointment, CAB vs. reference-market pathway, and Stage C tender readiness.
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