Interactive Guide to Hong Kong Medical Device Listing

Navigating the Medical Device Administrative Control System (MDACS)

The MDACS Framework

Hong Kong's medical device regulation is managed by the Medical Device Division (MDD) through the Medical Device Administrative Control System (MDACS). While currently voluntary, listing your device is becoming a strategic necessity. Government procurement policies for hospitals and clinics increasingly prioritize or require MDACS-listed devices. This interactive guide breaks down the process into clear, manageable steps to help you navigate the system effectively.

The system is also evolving. A new central body, the Hong Kong Centre for Medical Products Regulation (CMPR), is being established, and a mandatory digital submission platform (MDIS) is being rolled out. Staying informed is key to a successful market entry.

The Application Process at a Glance

Classify Device

Determine the risk class (I-IV or A-D).

Appoint LRP

Designate a Local Responsible Person.

Prepare Dossier

Compile all required documentation.

Submit via MDIS

Use the new mandatory online portal.

Approval

Undergo MDD assessment to get listing.

The 5-Step Application Pathway

Follow these five essential steps to list your medical device in Hong Kong. This section provides the details and tools needed for each stage of the process, from initial classification to final submission. Accurate completion of each step is critical for a smooth review by the MDD.

Step 1: Classify Your Device

Classification is based on risk. General devices are Class I-IV, and IVDs are Class A-D. Listing is required for Class II-IV and B-D devices. Use the tabs below to see examples and understand the criteria based on Technical References TR-003 and TR-006.

Class	Risk Level	Examples	MDACS Listing Required
I	Low	Surgical retractors, Tongue depressors	No
II	Low-moderate	Hypodermic Needles, Suction equipment	Yes
III	Moderate-high	Lung ventilator, Bone fixation plate	Yes
IV	High	Heart valves, Implantable defibrillator	Yes

✨ Ask AI: Classification Assistant

Describe your medical device, and AI can suggest its likely MDACS classification.

Step 2: Appoint a Local Responsible Person (LRP)

Foreign manufacturers must appoint an LRP. This entity is your legal and operational representative in Hong Kong, handling everything from the application to post-market surveillance. Their responsibilities are extensive and critical for compliance.

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Manage application & dossier submission
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Handle complaints & product recalls
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Primary responsibility for adverse event reporting
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Maintain supply & transaction records
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Arrange for device maintenance and servicing
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Act as primary contact for the MDD

Step 3: Prepare Your Dossier

The application route depends on whether you have prior approval in a reference country (e.g., USA, EU, Canada, China, Japan, Australia, Korea, Singapore). Select your route below to see the required documents.

Application Route:

Abridged Route (with reference country approval)

Full Conformity Assessment (no reference approval)

Required Documents

QMS Certificate (e.g., ISO 13485)

LRP's Business Registration Cert.

Manufacturer's Designation Letter

LRP Documented Procedures

Application Form (MD101/MD102)

Essential Principles Conformity Checklist

Risk Analysis Report/Summary

Clinical/Performance Evaluation Report

Device Labelling (IFU, labels)

Marketing Approvals from Reference Countries

Step 4: Submit via the Medical Device Information System (MDIS)

The MDD has transitioned to a mandatory online portal, MDIS, for all submissions. Paper-based applications are being phased out. The chart below visualizes the key transition dates. It is crucial to register for an MDIS account and use the e-service for all applications.

MDIS Transition Timeline

Step 5: Assessment & Approval

After your LRP submits the dossier, the MDD will conduct a thorough assessment. Be prepared for an iterative process; the MDD may issue 'deficiency letters' requesting additional information or clarification. A complete and well-organized initial submission is key to minimizing delays. Upon successful review, the MDD will issue a listing number and certificate, and you can begin commercialization.

📋 Assessment Process

Initial review by MDD staff
Technical assessment of dossier completeness
Potential requests for additional information
Final decision and listing certificate issuance

Post-Market Obligations

Gaining listing approval is not the final step. The MDACSincludes robust post-market surveillance requirements to ensure ongoing device safety and performance. The LRP is responsible for managing these obligations, which include adverse event reporting, managing any changes to the device, and handling renewals.

Adverse Event Reporting Timelines

The LRP must report events based on their severity. The chart below visualizes the strict reporting deadlines from the moment the LRP becomes aware of the incident.

Managing Device Changes (GN-10)

The LRP must notify the MDD of any changes made to a listed medical device. The type of notification depends on the significance of the change.

Major Change

Affects device Safety, Quality, or Performance (SQP). Requires prior approval from MDD.

Action: Submit Change Application (MD105) at least 12 weeks before implementation.

Minor Change

Does not affect device SQP. Can be implemented before approval.

Action: Notify MDD by submitting Change Application (MD105) within 24 weeks of awareness.

Key Policies & Schemes

Understanding the specific schemes and policies within MDACS can provide significant advantages. This section covers the Expedited Approval Scheme for faster market access, the current fee structure, and a look at the future of medical device regulation in Hong Kong.

Expedited Approval Scheme

This scheme offers a faster review for eligible Class II-IV devices. Key criteria include:

Approval from 2+ reference countries.
No history of death or serious injury worldwide.
No active recalls or ongoing adverse events.

Fees & Timelines

No official fees are currently charged for medical device listing applications.

The MDD does not publish official processing timelines. A complete dossier is the best way to avoid delays.

Listing Renewal

Device listings are valid for 5 years. A strict renewal window applies:

Submit renewal application between 1 year and 12 weeks BEFORE expiry.

Late submissions are not processed, and a new application will be required.

Disclaimer

This guide and the integrated AI features are for informational purposes only and should not be considered as a substitute for professional regulatory advice. The information may not be fully up-to-date, and the AI-generated content is experimental. Always consult with qualified professionals and the official MDD for guidance.

Class	Risk Level	Examples	MDACS Listing Required
A	Low Individual & Public Health Risk	Clinical chemistry analyser, Plain urine cup	No
B	Moderate Individual and/or Low Public Health Risk	Vitamin B12, Pregnancy self-testing, Urine test strips	Yes
C	High Individual and/or Moderate Public Health Risk	Blood glucose self-testing, HLA typing, PSA screening, Rubella	Yes
D	High Individual & Public Health Risk	Tests for HIV, HCV, HBV, HTLV blood donor screening	Yes