Intermediate2h 16m # Hong Kong Medical Device Registration: MDACS to Statutory CMPR The complete Hong Kong medical device registration course — MDACS listing from first principles, the Local Responsible Person role, both listing pathways, technical documentation, the mandatory March 2026 procurement transition, and the statutory CMPR regime taking shape behind it, built to full practical compliance. A manufacturer assumes MDACS listing is equivalent to statutory approval, describes it that way in investor material, and only learns the difference when a due diligence reviewer flags the misrepresentation. A company selects a Local Responsible Person on the lowest quoted annual fee alone, without checking real vigilance responsiveness, and discovers the gap the moment a genuine adverse event demands fast, capable execution within a 10-calendar-day reporting window. A team delays its listing application until months before the March 23, 2026 Stage C procurement deadline, betting on review capacity that the widely anticipated pre-deadline surge may not leave available. None of this is exotic — it's the ordinary, predictable cost of treating Hong Kong's administratively clever, transitional device framework as simpler than it actually is. This course teaches Hong Kong's medical device registration framework from first principles to full practical compliance. You'll learn exactly what MDACS is and why it exists, how the Medical Device Division currently operates, and what's known so far about the incoming statutory Centre for Medical Products Regulation. You'll go deep on device scope and the TR-003/TR-006 risk classification schemes, on the Local Responsible Person role and its real legal weight, and on both MDACS listing pathways — the reference country route built on an existing FDA, CE, TGA, or other recognized approval, and the full Conformity Assessment Body technical review route. From there, the course covers building a complete four-part technical documentation file, the actual MDIS application process from account setup through listing issuance, realistic timelines and fees across the full five-year listing lifecycle, and the mandatory Stage A/B/C procurement transition culminating in the binding March 23, 2026 deadline. You'll cover post-listing vigilance obligations in depth, bilingual labeling and advertising requirements, what's currently known and explicitly not yet confirmed about the statutory CMPR regime, how to prepare for that transition now, enforcement realities today versus tomorrow, a full walkthrough case study on a Class III connected device, common mistakes, and your own concrete action plan close out the course. Built on Krono's regulatory database and current guidance, covering the Medical Device Administrative Control System, the Department of Health's mandatory procurement rollout, and the Centre for Medical Products Regulation as they stood at the time of this course's production — including explicit treatment of device-specific statutory legislation that remains genuinely not yet enacted. This course contains the use of artificial intelligence for asthetic purposes. * Includes the ebook edition, free * 8 downloadable resources included ## What you'll learn * Choose and execute the right listing pathway — reference country route or Conformity Assessment Body route — for a specific device and evidence base * Build a complete, audit-ready four-part technical documentation file and navigate the MDIS application process from account setup through listing issuance * Navigate the mandatory Stage A/B/C procurement transition and the binding March 23, 2026 deadline with a defensible portfolio audit and submission plan * Run a durable post-listing compliance program: vigilance, distribution recordkeeping, complaint handling, and recall coordination within required timelines * Prepare proactively for the statutory CMPR transition and recognize the recurring, costly mistakes that undermine an otherwise sound MDACS compliance program ## Requirements * ·No prior Hong Kong regulatory background required — the course builds every concept from first principles * ·A working knowledge of your own device's classification and existing regulatory approvals is helpful but not required * ·Regulatory affairs professionals, quality leads, founders, and distributors bringing a medical device or IVD to the Hong Kong market will all benefit $199.00 One-time purchase · Lifetime access · No subscription Less than one hour with a compliance consultant. [First lesson free to preview: Hong Kong Medical Device Registration](#lesson-ba120a7e-c94c-4cde-9dc4-1862e7358aa0) * Explain what MDACS actually is, how it differs from a statutory approval regime, and what's currently known about the incoming statutory Centre for Medical Products Regulation * Correctly classify a device or in vitro diagnostic under the TR-003 or TR-006 risk-tier schemes and identify borderline scope questions with confidence * Appoint and manage a genuinely capable Local Responsible Person, understanding their legal weight and the real post-listing duties they carry Includes the ebook edition, free — read it in your [library](/profile/books) after purchase. Enroll — $199.00 Secure checkout via Paddle Not what you expected? Contact us within 14 days. Built from a regulatory graph already at work 1,506 users this week 661 guides 323 product types 9 markets ## Course content 153 lessons·1035 min total The Big Picture 7 lessons · 47 min * Hong Kong Medical Device Registration Preview6:46 * Why This Matters Right Now 6:46 * MDACS Today vs. the Statutory CMPR Tomorrow 6:46 * Who This Course Is Built For 6:46 * How This Course Is Structured 6:46 * The Real Cost of Treating This as Optional 6:46 * Knowledge Check: The Big Picture 6:46 The Legal & Regulatory Framework 8 lessons · 61 min Scope: What Counts as a Medical Device 8 lessons · 62 min Risk Classification: TR-003 and TR-006 7 lessons · 43 min The Local Responsible Person 8 lessons · 57 min The Two Listing Pathways 8 lessons · 54 min The Reference Country Route in Depth 8 lessons · 59 min The Conformity Assessment Body Route in Depth 8 lessons · 58 min Building the Technical Documentation File 8 lessons · 59 min The MDIS Application Process 8 lessons · 58 min Timelines, Fees & Listing Validity 8 lessons · 54 min The Mandatory Procurement Transition 8 lessons · 56 min Post-Listing Obligations 8 lessons · 58 min Labeling & Advertising Requirements 7 lessons · 43 min The Statutory CMPR Regime 7 lessons · 42 min Preparing for the Statutory Transition 7 lessons · 42 min Enforcement & Penalties 7 lessons · 42 min Full Walkthrough: A Class III Device End to End 8 lessons · 56 min Common Mistakes 7 lessons · 41 min Your Action Plan 7 lessons · 42 min What's Next 1 lessons · 0 min Enroll — $199.00