MDACS Medical Device Registration Hong Kong
LRP Consultant
Hong Kong remains one of Asia's most developed healthcare and medical technology markets. NexorTest delivers end-to-end MDACS listing Class II/III/IV and IVD listing, the Expedited Approval Scheme, Local Responsible Person (LRP) representation, Essential Principles and ISO 13485 compliance, and Conformity Assessment Body coordination all under one expert roof, and Stage C procurement ready.
Four Risk Based Classification
The MDD classifies general medical devices into four risk classes (IVDs into Class A-D) following IMDRF/GHTF principles. MDACS listing covers Class II-IV devices and Class B-D IVDs your class determines the pathway, documentation, and review.
Class I Devices
Low risk devices such as bandages, non powered instruments, and examination gloves. Outside MDACS listing scope no listing required, though they remain subject to general safety obligations.
- Not Listed
- Out of Scope
Class II Devices
Low to moderate risk devices such as thermometers, infusion sets, hypodermic needles, and many electro medical devices. Eligible for MDACS listing and the Expedited Approval Scheme.
- Listing Eligible
- Expedited Scheme
- 5 Year Validity
Class III Devices
Moderate to high risk devices including ventilators, orthopaedic implants, and many active therapeutic devices. Full Essential Principles evidence and robust QMS documentation required.
- CAB or Reference
- Clinical Evidence
- ISO 13485
Class IV Devices
Highest risk devices such as implantable defibrillators, heart valves, and life supporting implants. The most rigorous Essential Principles, clinical, and quality system review.
- Full Dossier
- Clinical Data
- Tracking
Three Routes to Your HKMD Listing Number
MDACS offers different pathways to market access. Choosing the right one based on your existing approvals and device class can remove the cost and months of a local conformity assessment.
Expedited Approval Scheme
For Class II/III/IV devices and Class B-D IVDs approved by two or more reference jurisdictions US FDA, EU, Health Canada, TGA, Japan PMDA, China NMPA, Korea MFDS, or Singapore HSA with a clean global safety record. Bypasses local CAB review by relying on reference approvals plus an Essential Principles checklist. Formalized by the MDD in January 2022.
Standard Route With Reference Approval
A single reference country marketing authorization (e.g. FDA, EU, or NMPA) plus an Essential Principles checklist supports a standard MDACS listing without a full local conformity assessment. Ideal where you hold one strong reference approval but not two.
Standard Route CAB Conformity Assessment
For devices without reference country approval, an MDD recognized Conformity Assessment Body (BSI, SGS, or TUV SUD) reviews your technical file, QMS, and clinical evidence against the Essential Principles before listing. The route for novel devices or those approved only in non reference markets.
Comprehensive Hong Kong Regulatory Services
From classification and LRP representation through adverse event reporting, NexorTest manages every aspect of your MDACS listing and post-market lifecycle.
MDACS Listing Application
Complete MDACS listing for Class II, III, and IV medical devices and Class B-D IVDs. We manage classification under TR-003/TR-006, pathway selection, dossier preparation, MDIS submission, and MDD query resolution end to end.
Expedited Approval Scheme
Priority review submissions that leverage two or more of your reference-country approvals FDA, EU, Health Canada, TGA, PMDA, NMPA, MFDS, or HSA. We assemble the reference evidence and Essential Principles checklist to bypass a local CAB review.
CAB Conformity Assessment
For devices without reference approval, we coordinate a Conformity Assessment Body (BSI, SGS, or TUV SUD) review of your technical file, QMS, and clinical evidence against the Essential Principles managing scope, timelines, and findings.
Local Responsible Person (LRP)
Independent in-country LRP services. NexorTest holds your HKMD listing neutrally, submits via MDIS, manages all MDD interactions, and lets you appoint or change distributors freely without losing control of your listing.
Essential Principles & ISO 13485
We build your Essential Principles of Safety and Performance checklist and align ISO 13485 evidence for both legal and physical manufacturers to MDD expectations the conformity backbone of every MDACS application.
Bilingual Labeling & IFU
English and Chinese labeling and Instructions for Use that meet MDD requirements home or lay use devices must be labeled in both languages. Discrepancy free translations that prevent the most common cause of MDD queries.
IVD Listing (Class B-D)
In Vitro Diagnostic listing under TR-006 and guidance note GN-06, including analytical and clinical performance evidence, reagent documentation, and Expedited Scheme submissions for IVDs already approved by reference authorities.
SaMD & Digital Health
Software as a Medical Device strategy under TR-007, where SaMD/SiMD are treated as active devices: software lifecycle and validation, cybersecurity risk assessment, AI/ML evidence, and a listing strategy aligned with MDD expectations.
Vigilance, Changes & Renewals
Post-market adverse event reporting (serious events within 10 days), change notifications via MD105, high risk device tracking and annual surveillance, and renewals submitted between 1 year and 12 weeks before your 5 year expiry.
Hong Kong's Trusted MDACS & LRP Specialist
We combine an on-the-ground Hong Kong regulatory team with global reference reliance expertise to deliver faster, more predictable MDACS listings and Stage C and CMPR readiness.
On-the-Ground Hong Kong Team
Bilingual (English/Cantonese/Mandarin) regulatory professionals who know the MDD, MDIS, and the guidance notes first hand not an offshore desk learning the system from a distance.
Expedited & Reference Reliance Specialists
We turn your existing FDA, EU, NMPA, or other approvals into an Expedited Approval Scheme submission that bypasses costly CAB review the fastest route to an HKMD number.
Independent LRP You Keep Control
We hold your listing as a neutral Local Responsible Person, so you can switch or add distributors anytime without your HKMD listing being held hostage by a single commercial partner.
Stage C & CMPR Transition Ready
We position you for the 2026 procurement mandate today and build the comprehensive technical file you'll need for the statutory CMPR regime avoiding the mandatory-registration backlog.
Transparent Fixed-Fee Packages
No hourly billing surprises. Our fixed fee scopes cover strategy, LRP, dossier, MDIS submission, and post-market support, with clear milestones the predictability incumbents rarely offer.
Six Steps to Your HKMD Listing
A proven, structured approach that minimizes MDD information requests and accelerates your path to the Hong Kong medical device market.
Classification & Pathway Strategy
We confirm your risk class under TR-003 (Class I-IV) or TR-006 for IVDs (Class A-D), verify MDACS scope, and select the optimal pathway Expedited, reference reliance, or CAB assessment based on your existing approvals.
Appoint Local Responsible Person
NexorTest is appointed as your independent LRP. We register your MDIS account and prepare the LRP business registration and authorization documentation required to submit on your behalf.
Dossier & Essential Principles
We compile the technical dossier: device description, classification rationale, Essential Principles checklist, ISO 13485 for legal and physical manufacturers, clinical/performance evidence, and bilingual labeling and IFU.
Reference Reliance or CAB Review
For Expedited/reference pathways we assemble the reference country authorizations. For devices without reference approval, we coordinate a Conformity Assessment Body (BSI, SGS, TUV SUD) review and certificate.
MDIS Submission & Query Management
We submit the listing application through MDIS and manage every MDD information request and clarification to keep the review moving and avoid an application being closed for resubmission.
HKMD Listing & Post-Market Surveillance
You receive your Hong Kong Medical Device (HKMD) listing number. We set up adverse event reporting and change notifications and manage renewals valid 5 years, renewed 1 year to 12 weeks before expiry.
MDACS Expertise Across Every Device Category
From implantables to digital health, our regulatory specialists cover the full breadth of medical technology entering the Hong Kong market.
- 🩺 Implantable Devices
- 🧬 In Vitro Diagnostics
- 💻 SaMD & Digital Health
- 🩻 Imaging & Radiology
- 🦴 Orthopaedics
- 💉 Infusion & Drug Delivery
- 🩸 Surgical Instruments
- 👁 Ophthalmics
- 🦷 Dental Devices
- 🏥 Electro-Medical Equipment
- 🧪 Laboratory Equipment
- 📱 Wearables & Remote Monitoring
Frequently Asked Questions for MDACS Hong Kong
What is MDACS medical device registration in Hong Kong?
MDACS (the Medical Device Administrative Control System) is the listing framework run by the Medical Device Division (MDD) of Hong Kong’s Department of Health. Established in 2004 as a transitional mechanism toward statutory regulation, it is the de facto gateway to the market. A Local Responsible Person (LRP) applies through the online Medical Device Information System (MDIS); on approval the MDD issues a Hong Kong Medical Device (HKMD) listing number valid for 5 years. Listing is technically voluntary, but since 23 March 2026 (Stage C) all applicable devices procured by the Department of Health must be MDACS-listed, making listing a commercial prerequisite. A statutory regime under the Centre for Medical Products Regulation (CMPR) is targeted for the end of 2026.
What are the MDACS device classification classes?
Hong Kong uses a four tier, risk based system aligned with IMDRF/GHTF principles. General medical devices follow TR-003 Class I (low risk), Class II (low moderate), Class III (moderate high), and Class IV (high risk). IVDs follow TR-006 and are classified Class A, B, C, and D. MDACS listing covers Class II-IV general devices and Class B-D IVDs, Class I general devices and Class A IVDs are outside the listing scope. SaMD and SiMD are treated as active medical devices under TR-007 and follow the same risk based rules.
What is a Local Responsible Person (LRP)?
A Local Responsible Person (LRP) is a Hong Kong based legal entity with valid business registration that acts as the official applicant and holder of an MDACS listing for a foreign manufacturer. Appointing an LRP is mandatory for any manufacturer without a Hong Kong entity. Only the LRP can submit via MDIS, and it is the sole point of contact with the MDD. Post-market, the LRP handles adverse event reporting (serious events within 10 calendar days), traceability records for the device lifetime or 7 years, complaint handling, recalls, and high risk device tracking. NexorTest provides independent LRP services so you keep full freedom over your distributors.
What is the Expedited Approval Scheme?
Formalized by the MDD in January 2022, the Expedited Approval Scheme offers priority review for eligible Class II-IV general devices and Class B-D IVDs. To qualify, a device must hold approvals from at least two recognized reference jurisdictions US FDA, EU, Health Canada, Australia TGA, Japan PMDA, China NMPA, Korea MFDS, or Singapore HSA and have a clean global safety record with no deaths, serious injuries, or active recalls. Qualifying devices bypass a local Conformity Assessment Body (CAB) review by relying on the reference approvals plus an Essential Principles checklist the fastest route to an HKMD listing number.
How long does MDACS listing take?
The MDD’s official target is to vet a complete application within 12 weeks of submission. In practice, review has often run several months and historically up to 12-24 months, depending on volume, device complexity, and MDD information requests. Devices qualifying for the Expedited Approval Scheme are reviewed on a priority basis and avoid the additional time of a local CAB conformity assessment the single biggest accelerator. Documentation completeness is the largest driver of timeline; NexorTest’s pre-submission review minimizes the information requests that pause the clock.
What documents are required for MDACS listing?
A listing application typically requires: the MDACS application form submitted via MDIS an Essential Principles checklist, conformity evidence (reference country marketing authorizations or a CAB certificate) a valid ISO 13485 certificate for both the legal and physical manufacturer, device description, intended use, and classification rationale under TR-003 or TR-006; labeling and IFU in English, Chinese, or both (home/lay use devices must be both); clinical and performance evidence appropriate to the class; and the LRP’s Hong Kong business registration certificate. NexorTest prepares and quality checks the full dossier and manages the MDIS submission.
Is ISO 13485 mandatory for MDACS listing?
Yes, in practice. The MDD requires a valid ISO 13485 certificate covering both the legal and physical manufacturer as evidence of conformity to the Essential Principles, submitted as part of the application. Equivalent QMS evidence such as MDSAP, or YY/T 0287 for some China origin devices, may be accepted. Hong Kong does not run a separate local GMP inspection conformity is shown through your QMS certification plus either reference country approvals or a CAB review. NexorTest provides ISO 13485 gap analysis and aligns your QMS evidence to MDD expectations before submission.
What is the cost of MDACS registration?
The MDD currently charges no government fee for inclusion of a device on the MDACS lists, so government cost is effectively zero. Budget instead for LRP representation, professional consulting fees for classification, dossier preparation, and MDIS submission and, for devices without two reference country approvals, Conformity Assessment Body (CAB) fees from BSI, SGS, or TUV SUD the largest cost component, scaling with device class and technical file scope. Note that fees are expected once the statutory CMPR regime replaces voluntary MDACS. NexorTest offers transparent fixed fee packages. Contact us for a free cost assessment.
Ready to Enter the Hong Kong Medical Device Market?
Get a free MDACS regulatory assessment from specialists in Hong Kong market access. Our experts will map your fastest route including the Expedited Approval Scheme to a Hong Kong Medical Device (HKMD) listing number.