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For Class D medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, the technical documentation requirements are extensive and must demonstrate compliance with safety, performance, and quality standards for high-risk medical devices. These documents are reviewed by the Medical Device Division (MDD) under the Department of Health.
Below is a detailed breakdown of the technical documentation required and the preparation guidelines specifically for Class D devices, including general devices and IVDs:
📁 I. Overview: What is “Technical Documentation” for MDACS?
Technical documentation refers to the structured set of documents that:
Describe the design, manufacture, and intended use of the device
Demonstrate conformity to the Essential Principles (GN-01 or GN-02)
Provide clinical and risk-based evidence supporting safety and performance
Class D devices must include more robust evidence than lower-class devices due to their high-risk nature.
📚 II. Technical Documentation Checklist for Class D MDACS Application
| No. | Document | Description |
|---|---|---|
| 1️⃣ | Device Description | - Overview of the device - Intended use and indications - Classification rationale (per TR-003 / TR-006) - Variants and accessories |
| 2️⃣ | Design and Manufacturing Information | - Design drawings, schematics, or block diagrams - Manufacturing processes (esp. sterilization, packaging) - Critical suppliers (e.g., sterilizers, software developers) |
| 3️⃣ | Essential Principles Checklist | - A table matching applicable principles from GN-01 or GN-02 to evidence in the technical file - Cross-reference to supporting data (test reports, CER, etc.) |
| 4️⃣ | Declaration of Conformity | - Signed by the manufacturer - Lists standards complied with (ISO, IEC, etc.) - Includes device name, model, and version |
| 5️⃣ | Risk Management Report | - Compliant with ISO 14971 - Hazard identification, risk estimation, benefit-risk analysis - Residual risk evaluation and control verification |
| 6️⃣ | Clinical Evaluation Report (CER) | - Required for all Class D devices - Based on literature review, clinical trial data, post-market surveillance - Follow MEDDEV 2.7/1 Rev 4 or IMDRF guidance |
| 7️⃣ | Labeling and Instructions for Use (IFU) | - Must include: ▪️ Device name, model, batch/serial number ▪️ Manufacturer and LRP name/address ▪️ Indications, warnings, contraindications ▪️ Cleaning, sterilization, storage, disposal info - Language: English and/or Traditional Chinese |
| 8️⃣ | Post-Market Surveillance (PMS) Plan | - Complaint handling, vigilance reporting, recall SOPs - Risk trend analysis and reporting frequency |
| 9️⃣ | Stability / Shelf Life Data | - Real-time or accelerated aging data for shelf-stable or sterile products - Packaging validation if sterile |
| 🔟 | Test Reports (performance & safety) | - Biocompatibility (ISO 10993) - Electrical Safety (IEC 60601 series) - EMC (IEC 60601-1-2) - Sterilization (ISO 11135, 11137, 11737, 11607, etc.) - Software validation (IEC 62304) |
| 1️⃣1️⃣ | Clinical Evidence Summary | - Summary of studies used in the CER - Must include number of subjects, endpoints, and results - Evidence from GHTF markets is acceptable |
| 1️⃣2️⃣ | UDI Information (if applicable) | - If device uses a UDI system (e.g., GS1, HIBCC), include device identifiers and barcode format |
| 1️⃣3️⃣ | Sample Product Images | - Color photos of the device, labeling, packaging, and key components |
| 1️⃣4️⃣ | Software Description File (if applicable) | - Software architecture, intended use - Validation and verification summary - Cybersecurity safeguards (if connected) |
📑 III. Format and Submission Guidelines
| Requirement | Details |
|---|---|
| Language | All documents must be in English or Traditional Chinese |
| File Format | PDF format only; files uploaded via MDIS |
| File Size Limit | Follow MDIS portal guidance (generally <10MB per file) |
| File Naming | Use clear file names, e.g., Risk_Management_Report_ISO14971.pdf |
| Referencing | Label all sections to match Essential Principles checklist |
| Confidentiality | Sensitive documents should be clearly marked “Confidential” (MDD respects IP rights but full content must still be submitted) |
🔎 IV. Additional Notes for Special Device Types
🔬 For IVD Devices:
Include analytical performance data:
Sensitivity, specificity, accuracy
Linearity, detection limits, reproducibility
Include clinical performance data from comparative studies
Address specimen types, sample handling, cross-reactivity, etc.
🔌 For Devices Containing Software:
Software BOM (Bill of Materials)
Risk classification (per IEC 62304)
Traceability matrix for requirements vs testing
Cybersecurity control documentation
♻️ For Sterile Devices:
Sterilization validation (method, cycle data, residuals)
Packaging integrity testing
Shelf-life real-time/accelerated data
Batch release test summary
✅ V. Summary Table
| Category | Mandatory for Class D |
|---|---|
| Device description | ✅ |
| Risk management | ✅ |
| Clinical evaluation | ✅ |
| Labeling & IFU | ✅ |
| PMS & vigilance | ✅ |
| Design & manufacturing | ✅ |
| Safety/performance test reports | ✅ |
| UDI data | ✔️ If applicable |
| Software validation | ✔️ If applicable |
| Sterilization & packaging | ✔️ If applicable |
📌 Final Advice
Use the MDACS Device Submission Guide as your master reference.
Maintain a Technical Documentation Index (TOC) for quick navigation during submission and MDD queries.
Prepare documents in advance of submission, especially for Class D, since MDD may take 3–9 months to review.
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Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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