Shenzhen Operations & Hong Kong Advisory
HERO
WHO WE ARE
DSK is a dual-city medical device group. From Shenzhen, we have spent over a decade bringing international dental brands to Chinese clinicians. From Hong Kong, we advise device and life-science companies on regulatory affairs and cross-border market access.
REGULATORY & MARKET ACCESS (HK)
As Hong Kong's MDACS becomes mandatory, we help manufacturers get listed and stay compliant:
· MDACS listing — classification, pathway assessment, dossier preparation and submission, progress tracking
· LRP services — acting as your statutory LRP under COP-01: vigilance, adverse event reporting, record-keeping, recall coordination, DH liaison
· Cross-border access pathways — the GBA "药械通" scheme, and Hong Kong as a launchpad for international certification
· Clinical trial advisory — connecting trial resources across borders
Eleven years in dental devices. A Hong Kong-based regulatory team.
We bridge products — and the rules that move them — between China and the world.
Alongside our advisory practice, our Shenzhen operation has spent eleven years doing what regulators don't do — actually getting devices to clinicians.
DISTRIBUTION (SHENZHEN)
WHY DSK
POLICY ALIGNMENT
CTA
Premium international dental brands for Chinese clinicians — endodontics, imaging, magnification — backed by 11 years of hospital tendering experience and full-channel capability.
Founded 2015 · 20+ international brand partnerships · 150+ hospital projects · Dual operations in Shenzhen & Hong Kong
Our advisory practice aligns with the HKSAR First Five-Year Plan (2026–2030) on medical innovation and the Northern Metropolis life & health corridor.
Talk to us about your market entry — info@hkdsk.com
THE TEAM
One Team. Two Cities.
DSK's strength: every link in the chain is real and accountable.
Founder · Principal, HK Company
Over a decade in the medical device industry. Built the Shenzhen practice from scratch, representing 20+ international brands including NSK and KOMET across 150+ hospital projects. Having witnessed China's device industry shift from the channel era to the compliance era, he navigates both regulatory languages and business cultures with ease. Now based in Hong Kong, focusing on device regulatory and cross-border market access advisory, and serving as Local Responsible Person (LRP) for overseas manufacturers.
Shenzhen Operations Team
The Shenzhen company is the solid backbone of our advisory practice: a brand & business team maintaining 20+ manufacturer relationships, a bidding team with 157 hospital tenders completed, and a warehousing & logistics team ensuring clinical delivery. The Shenzhen team also provides on-the-ground support for cross-border projects — channel research, distributor matching and after-sales coordination.
Extended Expert Network
The HK company runs a boutique advisory model: founder-led, drawing on regulatory affairs (RA) specialists, clinical advisors, tax and legal counsel, and cross-border logistics partners as projects require. Clients get principal-level attention — with a network's execution power.