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What are the standards for Class C medical device MDACS registration in Hong Kong?
Release time：2025-06-25 15:41:45 The author: source:
For Class C medical devices under the Medical Device Administrative Control System (MDACS) in Hong Kong, applicants must demonstrate compliance with recognized international standards that ensure the device’s safety, quality, and performance. These standards are applied through the Essential Principles of Safety and Performance framework (as described in MDACS GN-03), which is based on guidelines from the Global Harmonization Task Force (GHTF).

For Class C medical devices under the Medical Device Administrative Control System (MDACS) in Hong Kong, applicants must demonstrate compliance with recognized international standards that ensure the device’s safety, quality, and performance. These standards are applied through the Essential Principles of Safety and Performance framework (as described in MDACS GN-03), which is based on guidelines from the Global Harmonization Task Force (GHTF).

Below is a complete overview of the applicable standards, how to use them, and how to present them in your MDACS submission.

🔹 1. Framework: Essential Principles of Safety and Performance (GN-03)

All Class C devices must demonstrate conformity with the Essential Principles (EPs) listed in Guidance Note GN-03. There are 13 general principles and specific principles depending on the device’s nature.

Examples of EPs include:

  • Device must not compromise health or safety (EP 1)

  • Must perform as intended (EP 2)

  • Must be designed and manufactured in line with ISO 13485 (EP 5)

  • Biological compatibility and safety (EP 9)

  • Protection against electrical hazards (EP 11)

  • Accurate measurement functions (EP 13)

📄 You must submit a completed checklist showing how each applicable principle is met and what standards/test reports support them.

🔹 2. Recognized International Standards for Class C Devices

The Medical Device Division (MDD) accepts internationally recognized standards—especially those from:

  • International Electrotechnical Commission (IEC)

  • International Organization for Standardization (ISO)

  • ASTM International

  • IMDRF / GHTF-endorsed standards

  • European harmonized EN standards

  • US FDA-recognized consensus standards

✅ Common Standards for General Class C Devices

AreaStandardDescription
QMSISO 13485:2016Quality management system for medical devices
Risk ManagementISO 14971:2019Risk management process throughout product lifecycle
Electrical SafetyIEC 60601-1:2005+A1:2012General safety for electrical medical equipment
EMCIEC 60601-1-2:2014Electromagnetic compatibility for medical devices
Software Life CycleIEC 62304:2006Medical device software development processes
Usability EngineeringIEC 62366-1:2015Usability of medical devices for safety
BiocompatibilityISO 10993 seriesAssessment of biological safety of materials
Sterilization (Steam)ISO 17665-1Requirements for sterilization of health care products
Sterile PackagingISO 11607-1/-2Packaging for terminally sterilized medical devices
Clinical EvaluationMEDDEV 2.7/1 rev.4 (EU MDR)Clinical evaluation guidance
Performance TestingASTM/ISO/IEC standardsDepends on device function (e.g., infusion, imaging)

✅ Examples for Specific Device Types

Device TypeRelevant Standards
Infusion pumpsIEC 60601-2-24 (Particular requirements for infusion pumps)
Surgical lasersIEC 60601-2-22 (Laser equipment safety)
Patient monitorsIEC 60601-2-49
Diagnostic X-rayIEC 60601-2-54
Implantable cardiac devicesISO 14708 series
Dialysis machinesISO 8637
Blood glucose metersISO 15197

🔹 3. How to Use Standards in Your MDACS Submission

✅ Step-by-Step:

  1. Match Each EP in GN-03 with one or more standards that demonstrate compliance.

  2. List the standards in your Essential Principles Checklist (required).

  3. Include test reports or certificates showing compliance with those standards:

    • Third-party test reports (e.g., IEC 60601)

    • Internal verification reports

    • CE test reports or FDA 510(k) summary if applicable

  4. Ensure alignment between your standards, device design, and labeling.

📋 Example from Essential Principles Checklist (EP vs. Standard):

EP No.DescriptionStandard UsedEvidence
EP 2Design & manufacturing safetyISO 13485:2016Valid QMS certificate
EP 5Biological compatibilityISO 10993-1/-5/-10Biocompatibility test report
EP 11Electrical safetyIEC 60601-1Test report from UL
EP 12Software validationIEC 62304Internal software validation report
EP 13Measurement accuracyISO 15197In-house calibration and accuracy report

🔹 4. Tips and Precautions

TipReason
✅ Use latest version of standardsOlder versions may not be accepted
✅ Choose reference market-recognized standardsAligns with CE/FDA/TGA documents
✅ Keep test reports complete and in EnglishMDD does not accept summaries or Chinese-only reports
✅ Include evidence of test house accreditation (e.g., CNAS, IEC/ISO 17025)Strengthens credibility of results
❌ Avoid claiming compliance without documentationUnsupported claims may lead to delays or rejection

📌 Summary Table: Key Standards for Class C MDACS

Standard CodeArea of ComplianceDevice Category
ISO 13485QMSAll
ISO 14971Risk managementAll
IEC 60601-1Electrical safetyPowered devices
IEC 60601-1-2EMCAll active devices
ISO 10993BiocompatibilitySkin/mucosal/blood contact
IEC 62304Software validationSoftware-based devices
ISO 17665SterilizationSterile devices
IEC 60601-2-24Infusion pump specificsInfusion devices

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