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What are the standards for Class D medical device MDACS registration in Hong Kong?
Release time：2025-07-08 15:37:00 The author: source:
For Class D medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), the Medical Device Division (MDD) requires compliance with recognized international standards to demonstrate that the device meets the Essential Principles of Safety and Performance (EPs). Class D devices, being high-risk (e.g., implantables, life-support devices, high-sensitivity IVDs), are subject to the most stringent conformity requirements.

For Class D medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), the Medical Device Division (MDD) requires compliance with recognized international standards to demonstrate that the device meets the Essential Principles of Safety and Performance (EPs). Class D devices, being high-risk (e.g., implantables, life-support devices, high-sensitivity IVDs), are subject to the most stringent conformity requirements.

Below is a comprehensive guide to the applicable standards, how they are used in the MDACS process, and how you can demonstrate compliance.

✅ 1. Regulatory Foundation: Essential Principles (EPs)

All Class D devices must comply with:

  • GN-01: Essential Principles of Safety and Performance of Medical Devices

  • GN-02: Essential Principles for IVD Medical Devices (for in vitro diagnostics)

You are required to demonstrate compliance with these EPs by referencing internationally recognized standards.

✅ 2. Recognized International Standards

Hong Kong’s MDACS system is modelled on the GHTF/IMDRF framework, and accepts international consensus standards, especially those recognized in:

  • EU (CE marking under MDR/IVDR)

  • USA (FDA)

  • Canada (Health Canada)

  • Australia (TGA)

  • Japan (PMDA)

The table below outlines key applicable standards for Class D devices by category:

🔬 A. General Product Safety Standards

CategoryStandardDescription
General safetyISO 14971Risk management for medical devices
Quality systemISO 13485Quality management systems
BiocompatibilityISO 10993 seriesEvaluation of biological safety
Sterilization (ethylene oxide)ISO 11135Validation of EO sterilization
Sterilization (radiation)ISO 11137Validation of radiation sterilization
Sterility assuranceISO 11737-1/2Bioburden and sterility testing
Packaging validationISO 11607-1/2Packaging for terminally sterilized medical devices

⚡ B. Electrical & Electromedical Devices

CategoryStandardDescription
Electrical safetyIEC 60601-1General safety of electrical medical devices
EMC (electromagnetic compatibility)IEC 60601-1-2Electromagnetic disturbance and immunity
Software life cycleIEC 62304Medical device software development
Usability engineeringIEC 62366Human factors and usability
AlarmsIEC 60601-1-8Alarm systems in medical devices
Programmable systemsIEC 60601-1-4Programmable electrical systems in MDs

💉 C. Implantable Devices

Device TypeStandard
Active implantable medical devicesEN 45502 series
Orthopedic implantsISO 5832 series
Cardiovascular implantsISO 25539 series
Pacemakers/defibrillatorsISO 14708 series

🧪 D. In Vitro Diagnostic Devices (IVDs)

CategoryStandard
General requirements for IVDsISO 15189, ISO 13485, ISO 14971
Performance evaluationCLSI guidelines (EP series)
Sample collection devicesISO 18113 (labeling), ISO 23640 (stability)
Molecular diagnosticsISO 17822 series, ISO 15198
Calibration & traceabilityISO 17511

🔍 Note: Clinical performance and analytical performance data must also comply with international guidelines (e.g., CLSI, FDA, or EUDAMED-recognized data).

🌐 E. Software and Cybersecurity

CategoryStandard
Software lifecycle processesIEC 62304
Cybersecurity for networked devicesIMDRF N60 + FDA guidance
AI/ML softwareIMDRF AIWG or FDA Good Machine Learning Practices (GMLP)

📌 3. Use of Standards in MDACS Registration

You must:

  1. List each standard used in your Essential Principles Checklist.

  2. Provide objective evidence (e.g., test reports, certificates) to show conformity.

  3. Ensure all referenced standards are the latest or currently valid versions.

  4. Use equivalent international standards if device is already approved in a GHTF market (e.g., CE marked with EN standards under MDR).

📄 4. Documentation Linking Standards to Compliance

DocumentIncludes Standards?Notes
Declaration of Conformity✅Lists all applied standards and compliance status
Risk Management Report✅Must align with ISO 14971
Test Reports✅Must cite ISO/IEC standards used in testing
Clinical Evaluation✅May use GHTF-recognized clinical trial or literature standards
PMS / Vigilance Plan✅Align with ISO 20416 or ISO 13485 clause 8.2.1
Software Validation Report✅Must follow IEC 62304 and IEC/TR 80002-1 if applicable

✅ 5. Summary Table: Core Standards for Class D MDs in MDACS

PurposeStandardRequired
Risk ManagementISO 14971✅
QMSISO 13485✅
Clinical EvaluationMEDDEV 2.7/1 Rev 4 / IMDRF✅
Electrical SafetyIEC 60601-1✔️ If electrical
EMCIEC 60601-1-2✔️ If applicable
SoftwareIEC 62304✔️ If applicable
SterilityISO 11135 / 11137 / 11737✔️ If sterile
BiocompatibilityISO 10993 series✔️ If body-contacting
IVD performanceISO 15189 / CLSI / ISO 23640✔️ If IVD

🧩 Final Notes

  • You don’t need to test to every standard—only those relevant to your device type and risk profile.

  • Include the version number and year of each standard used.

  • Ensure all third-party test reports reference the correct standard and test method.

  • In case of non-standard approaches (e.g., novel device types), provide a rationale and equivalency evidence.

Would you like a customized checklist of standards tailored to your device (e.g., implant, ventilator, IVD, or software-based device)? I can generate that for your QA/regulatory team.

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Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


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