Hong Kong Medical Device Registration Guide: MDACS Listing, Local Responsible Person, and Transition Planning

Why Hong Kong Matters for Medical Device Market Entry

Hong Kong regulates medical devices through the Medical Device Administrative Control System (MDACS), a voluntary listing framework administered by the Medical Device Division (MDD) of the Department of Health. Established in 2004, MDACS was designed as a transitional mechanism toward full statutory regulation and has since become the de facto gateway for medical device market access in Hong Kong.

While listing remains technically voluntary, the landscape has shifted dramatically. Since March 23, 2026, all applicable medical devices procured by the Department of Health must be MDACS-listed — a requirement known as Stage C of the Enhanced Medical Device Procurement Strategy. This means unlisted devices are now excluded from all government quotations and tenders. With Hong Kong's public healthcare system (managed by the Hospital Authority) serving the vast majority of patients, MDACS listing is effectively a prerequisite for commercial viability.

Hong Kong is also preparing a major regulatory overhaul. The government plans to establish the Centre for Medical Products Regulation (CMPR), expected to become operational by 2026–2027, which will transition MDACS from a voluntary system to a mandatory registration regime with full legislative backing. Manufacturers who secure MDACS listings now will be better positioned for the transition.

Regulatory Framework Overview

Governing Legislation and Guidance

Hong Kong currently has no specific statute governing medical devices. Instead, regulation operates through guidance documents and technical references issued under MDACS:

Key Principles

• Voluntary listing with commercial necessity: Class II–IV general medical devices and Class B–D IVDs may be listed voluntarily, but Stage C procurement rules make listing essential for public sector sales
• No government fees: MDACS listing is currently free of charge
• Reference country recognition: Devices approved by FDA, EU Notified Bodies, Health Canada, TGA Australia, PMDA Japan, NMPA China, MFDS South Korea, or HSA Singapore qualify for expedited pathways
• 5-year listing validity: Listings are valid for five years and must be renewed before expiry
• LRP-centric model: All post-market obligations fall on the Local Responsible Person, not the foreign manufacturer

Medical Device Classification in Hong Kong

General Medical Device Classification (TR-003)

Hong Kong classifies general medical devices into four classes using rules adapted from the Global Harmonization Task Force (GHTF) document GHTF/SG1-N15:2006, which aligns with the IMDRF framework:

Class I devices are outside the scope of MDACS listing and do not require registration.

IVD Classification (TR-006)

IVDs are classified separately into four classes:

Class A IVDs are outside MDACS listing scope.

The MDACS Listing Process

Step 1: Appoint a Local Responsible Person (LRP)

Foreign manufacturers without a legal entity in Hong Kong must appoint an LRP. The LRP must be:

• A legal entity incorporated in Hong Kong, or
• A natural or legal person with a valid Hong Kong Business Registration Certificate

The LRP is the sole point of contact between the manufacturer and the MDD. The LRP holds the listing and is legally responsible for all regulatory obligations in Hong Kong.

LRP responsibilities include:

• Submitting and maintaining device listing applications
• Maintaining distribution and traceability records (for at least the device lifetime or 7 years, whichever is longer)
• Operating a documented complaint handling system with public-facing contact methods
• Reporting adverse events within defined timelines (serious events within 10 calendar days)
• Coordinating product recalls and field safety corrective actions
• Arranging maintenance and service support where applicable
• Implementing tracking systems for specified high-risk devices, including annual surveillance reporting
• Maintaining records available for inspection by the MDD

The LRP's obligations are detailed in COP-01 Code of Practice for Local Responsible Persons.

Step 2: Prepare Technical Documentation

The application consists of four parts submitted through the Medical Device Information System (MDIS):

Part A — Manufacturer Information:

• Manufacturer's letter designating the LRP
• ISO 13485 certificate (or FDA Establishment Inspection Report) for both the legal manufacturer and physical manufacturer
• Manufacturer contact details in English and Traditional Chinese

Part B — LRP Information:

• Valid Hong Kong Business Registration Certificate
• LRP contact details in English and Traditional Chinese
• Documented procedures for complaint handling, adverse event reporting, and recall coordination

Part C — Device Information:

• Device name, model, and description
• Classification according to TR-003 or TR-006 with rule justification
• Intended purpose and indications for use
• Instructions for use (IFU) in English and Traditional Chinese
• Labels and packaging information
• Sterilization method (if applicable)
• Photographs of the device and packaging

Part D — Marketing Approvals and Essential Principles:

• Conformity Assessment Certificate from an MDACS-accredited Conformity Assessment Body (CAB), OR
• Evidence of approval from a recognized reference country (see Pathways below)
• Essential Principles Conformity Checklist
• Risk analysis documentation
• Clinical evidence or evaluation report

Step 3: Select the Appropriate Listing Pathway

Hong Kong offers two primary listing pathways:

Pathway 1: Reference Country Route (Most Common)

If the device holds approval from one of the following recognized regulatory authorities, the manufacturer can bypass local CAB review:

• United States (FDA 510(k) clearance, De Novo, or PMA approval)
• European Union (CE marking from a Notified Body)
• Australia (TGA inclusion)
• Canada (Health Canada Medical Device License)
• Japan (PMDA approval)
• China (NMPA registration certificate)
• South Korea (MFDS approval)
• Singapore (HSA registration)

This pathway requires submission of the reference country approval certificate as evidence of conformity, along with the Essential Principles checklist and supporting documentation.

Pathway 2: Conformity Assessment Body (CAB) Route

For devices without reference country approval, the manufacturer must engage an MDACS-accredited CAB to conduct a conformity assessment. CABs operating in Hong Kong include BSI, SGS, and TUV SUD. The CAB reviews the technical file, quality management system documentation, and clinical evidence against the Essential Principles of Safety and Performance.

Expedited Approval Scheme

Since January 2022, Hong Kong offers an Expedited Approval Scheme for selected Class II–IV general medical devices and Class B–D IVDs. Eligibility criteria are determined by the MDD on a case-by-case basis, typically for devices addressing unmet clinical needs or incorporating innovative technology.

Step 4: Submit Application via MDIS

The LRP submits the complete application through the online Medical Device Information System (MDIS). The MDD reviews the submission and may request supplementary information. If the information remains insufficient by the specified deadline, the application will be closed and must be resubmitted.

Step 5: Listing Approval

• Official review time: 12 weeks from submission of all required information
• Actual time: Can extend to several months depending on MDD workload and query response time
• Listing validity: 5 years from the date of approval
• Government fee: None (free of charge)

Upon approval, the device receives an HKMD listing number.

Step 6: Renewal and Changes

• Renewal: Must be submitted between 12 weeks and 1 year before expiry. Applications submitted less than 12 weeks before expiry will not be processed.
• Major changes: Require prior MDD approval before implementation
• Minor changes: Require notification to the MDD

Stage C: Mandatory MDACS Listing for Government Procurement

Hong Kong's Enhanced Medical Device Procurement Strategy is implemented in stages:

Under Stage C, all applicable medical devices (Class II/III/IV general medical devices and Class B/C/D IVDs) procured by the Department of Health must hold a valid MDACS listing. Suppliers must provide a copy of the valid listing certificate with HKMD listing number at the time of quotation or tender submission.

This requirement directly affects eligibility for:

• Hospital Authority procurement
• Department of Health direct purchases
• Government fund purchases

Manufacturers without MDACS listings are now excluded from all public healthcare procurement in Hong Kong.

Labeling Requirements

Labeling must comply with TR-005 Additional Medical Device Labelling Requirements. Key requirements include:

• Labels and IFUs must be in English and Traditional Chinese
• If only one language is provided, a supplementary statement must be included per GN-01
• Device name, manufacturer name, and LRP name must appear in both languages
• IFUs (user manuals) must be available in both English and Traditional Chinese
• Other documents (e.g., maintenance manuals) should preferably be bilingual but must be in at least one of the two languages

The Upcoming Mandatory Registration Framework

Hong Kong is preparing to replace MDACS with a statutory mandatory registration system. The key developments include:

Centre for Medical Products Regulation (CMPR)

• Expected to become operational by 2026–2027
• Will oversee registration, vigilance, and post-market surveillance of all medical devices
• Will have statutory enforcement powers not available under the current voluntary system

Implications of the Transition

• All devices will likely require registration to be sold in Hong Kong (not just those in public procurement)
• Enhanced documentation requirements: complete technical files, risk management documentation, design dossiers, and clinical evaluation reports
• Expanded LRP responsibilities: More formalized obligations with statutory backing
• Potential introduction of government fees: The current free-of-charge model is unlikely to persist under a mandatory system
• Grandfathering provisions: Existing MDACS listings may be transitioned to the new system, though the specifics have not been finalized

Transition Planning for Manufacturers

1. List now under MDACS: Existing listings are likely to receive preferential treatment during transition
2. Prioritize Class III/IV devices: Higher-risk devices will face the most scrutiny under the new framework
3. Ensure complete technical files: Begin preparing full technical documentation now, not just the abbreviated MDACS submission
4. Strengthen LRP relationships: The LRP role will become more demanding under the mandatory system

Greater Bay Area Opportunities

Hong Kong-listed medical devices can also access mainland China through the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Connect Scheme. Under this scheme, devices that are clinically urgent, already marketed in Hong Kong/Macao, and used by public hospitals in those regions may be included in an approved catalog for use in designated hospitals across Shenzhen, Guangdong, Zhuhai, and other major GBA cities. As of December 2025, 71 designated hospitals participate in the scheme.

This provides an indirect pathway to the Chinese market without going through the full NMPA registration process.

Practical Timeline and Cost Estimates

Typical Timeline

Cost Estimates

Comparison with Other Asian Markets

Key Takeaways

1. Stage C is now in effect: Since March 23, 2026, MDACS listing is mandatory for all Department of Health procurement — act now if your devices serve the public healthcare system
2. No government fees, but plan for the future: Listing is currently free, but fees are expected when the mandatory CMPR system launches
3. Reference country pathway is fastest: If you have FDA, CE, TGA, Health Canada, PMDA, NMPA, MFDS, or HSA approval, leverage it for expedited listing
4. LRP selection is critical: The LRP bears significant post-market obligations — choose an established entity with robust quality systems
5. Prepare for mandatory regulation: The CMPR transition means all manufacturers should begin building comprehensive technical files now
6. GBA Connect is a bonus: Hong Kong listing opens an indirect pathway to designated hospitals in mainland China's Greater Bay Area