From 23 March 2026, medical devices procured by the Hong Kong Department of Health must hold a valid MDACS listing. We help manufacturers get listed, stay compliant, and use Hong Kong as the gateway to the Greater Bay Area — with a distribution backbone that has served clinicians for over a decade.

DSK Medical Technology (HK) Limited runs a boutique, principal-level regulatory and market-access advisory practice. We work with device and life-science manufacturers entering Hong Kong and the Greater Bay Area, and with Chinese device makers going global via Hong Kong.

What makes us different: our group has spent eleven years actually getting devices into hospitals — 20+ international brand partnerships and 150+ hospital projects through our Shenzhen operation. When we advise you on a listing pathway or an access strategy, we know what happens after the certificate is issued, because distribution is our home ground.

Every engagement is led by the principal — supported by a curated network of RA specialists, clinical advisors and cross-border logistics partners as your project requires.

Medical device industry experience

International brand partnerships

Hospital projects delivered

International brand partnerships

Overseas manufacturers need a statutory Local Responsible Person in Hong Kong. We act as your LRP under the MDACS Code of Practice — so you can serve the market without setting up a local entity.

The Greater Bay Area "药械通" scheme lets specified medical devices reach designated GBA healthcare institutions ahead of full national registration. We map whether — and how — it fits your product.

Clinical evidence is increasingly the gatekeeper for device approval and adoption. We connect trial resources across Hong Kong and mainland China and keep the compliance picture coherent on both sides.

MDACS Regulatory Advisory

Listing & Compliance

Note: vetting of a complete listing application normally takes around 12 weeks — plan your tender calendar accordingly.

GBA Cross-Border Access

Clinical Trial Advisory

LRP Services

药械通 & Market Entry

Local Responsible Person

Evidence & Trials

Hong Kong's Medical Device Administrative Control System is transitioning from voluntary to mandatory. We guide manufacturers through the entire listing process under the Medical Device Division (MDD) framework.

① Clinical trial strategy & evidence-gap assessment

② Ethics committee application advisory in Hong Kong

③ Site and institution liaison across HK & mainland networks

④ Multi-centre coordination and document alignment

⑤ Post-trial: linking evidence to listing & procurement files

① Device classification assessment (Class II–IV general devices, Class B–D IVDs)

② Listing pathway strategy & recognised regulatory approvals review

③ Dossier preparation, documentation and QMS evidence (ISO 13485) advisory

④ Submission, query response and progress tracking

⑤ Stage C readiness check for DH tender & quotation eligibility

Your device, LRP, importer and distributor records appear in the public MDIS databases — we keep them accurate.

We also advise Chinese device makers on structuring HK operations for outbound market access.

We advise on trial strategy and compliance — trial conduct is delivered with our clinical partner network.

① Acting as your LRP with listing under MDACS

② Vigilance & adverse event reporting to the Department of Health

③ Record-keeping and recall coordination

④ Standing liaison with the Medical Device Division

⑤ Annual compliance health-check & renewal reminders

① Eligibility assessment against designated-institution product needs

② Application advisory for the GBA specified-device pathway

③ Hong Kong as a launchpad toward international certification

④ Dual-market strategy: GBA institutions + full NMPA route

⑤ Channel research & distributor matching through our mainland network