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The technical documentation for a Class C medical device submitted under the Medical Device Administrative Control System (MDACS) in Hong Kong is a core part of the application. It must demonstrate that the device is safe, effective, and compliant with the Essential Principles of Safety and Performance as outlined in MDACS guidance documents GN-02 and GN-03.
Below is a detailed overview of the technical documentation structure and requirements for Class C devices.
📦 Technical Documentation Requirements for Class C Medical Devices
Your submission should follow the Common Submission Dossier Template (CSDT), as specified in Guidance Note GN-02. The MDD requires both hard copy and electronic copy (on USB or CD-ROM).
🔹 1. Device Description and Product Overview
| Content | Requirements |
|---|---|
| Device name, model(s), catalog numbers | Must match those used in reference markets |
| Intended purpose / indications for use | In clear, concise terms |
| Device class justification | Based on GN-01 (confirm Class C) |
| Photographs or illustrations | Label views, physical appearance |
| Principle of operation | Include diagrams if needed |
| Variant details | All versions must be covered or individually listed |
🔹 2. Labeling and Instructions for Use (IFU)
| Content | Requirements |
|---|---|
| Device labeling (primary, secondary packaging) | Must be in English or Chinese |
| Instructions for Use (IFU) | Must match intended use and show how to use safely |
| Any promotional brochures | Optional, but helpful |
| Symbols used | Must comply with recognized standards like ISO 15223-1 |
🔹 3. Design and Manufacturing Information
| Content | Requirements |
|---|---|
| Device specifications | Including materials, dimensions, tolerances |
| Engineering drawings / block diagrams | Especially for electrical/electronic devices |
| Software description (if applicable) | Version, architecture, risk classification per IEC 62304 |
| Manufacturing process overview | Describe critical steps, sterilization (if applicable) |
🔹 4. Essential Principles and Methods of Compliance
| Content | Requirements |
|---|---|
| Essential Principles Checklist | Completed per GN-03 |
| Supporting standards | List of applicable recognized standards (e.g., IEC 60601, ISO 10993, ISO 13485) |
| Test reports and data | Electrical safety, EMC, biocompatibility, performance testing, etc. |
📌 Tip: Use GN-03’s checklist template and reference exact clauses of test reports.
🔹 5. Risk Analysis and Control
| Content | Requirements |
|---|---|
| Risk Management File | As per ISO 14971:2019 |
| Hazard identification | Must include foreseeable misuse |
| Risk evaluation and control measures | Should match actual design features and IFU warnings |
| Residual risk acceptability | Demonstrated via summary or matrix |
🔹 6. Product Verification and Validation
| Content | Requirements |
|---|---|
| Pre-clinical testing | Bench, mechanical, software, environmental, etc. |
| Sterilization validation | If sterile, include method and SAL evidence |
| Shelf life testing | Aging data, packaging validation |
| Biocompatibility | Required for patient-contacting components per ISO 10993 series |
| EMC and electrical safety | IEC 60601-1, IEC 60601-1-2 for active devices |
| Software validation | If applicable, per IEC 62304 |
🔹 7. Clinical Evidence
| Content | Requirements |
|---|---|
| Clinical evaluation report (CER) | May include: |
Literature review
Post-market data
Equivalence rationale |
| Clinical investigation | Required for novel or high-risk features |
| Equivalence claim | Must compare:Intended use
Design
Technical characteristics
Performance and safety |
🔹 8. Reference Market Regulatory Approval
| Content | Requirements |
|---|---|
| Copy of CE certificate (MDR), FDA 510(k)/PMA, TGA ARTG, etc. | Must be valid and for the exact model |
| Free sale certificate or registration letter | From reference country authorities |
| Device listing / approval numbers | If available (e.g., FDA Device Listing Number) |
🔹 9. Quality Management System Documentation
| Content | Requirements |
|---|---|
| ISO 13485 certificate | For the manufacturer, issued by accredited body |
| Scope of certification | Must cover product category |
| Manufacturing site address | Must match on all forms and certificates |
| Quality manual excerpt (optional) | To support overall system control and traceability |
🔹 10. Declaration of Conformity (DoC)
| Content | Requirements |
|---|---|
| Manufacturer’s declaration | Confirming compliance with GN-03 Essential Principles |
| Signed and dated | By authorized person of the manufacturer |
| Standards referenced | Include key harmonized standards used in testing |
| Format | PDF preferred (paper original also needed) |
🗂 Document Format and Organization
| Format | Requirement |
|---|---|
| Paper submission | One complete set of printed documents |
| Digital submission | One USB or CD-ROM, files in PDF or DOC format |
| Language | English or Chinese only |
| Folder organization | Clear sections, use document index or contents page |
| File naming | Match printed document headings (e.g., "Section 3_Risk Analysis.pdf") |
✅ Summary Table: Class C MDACS Technical Dossier
| Section | Key Documents |
|---|---|
| 1. Device Description | Device overview, model list, photos |
| 2. Labeling & IFU | Packaging, labeling, instructions |
| 3. Design & Manufacturing | Specs, drawings, software details |
| 4. Essential Principles | GN-03 checklist + standards/test data |
| 5. Risk Analysis | ISO 14971-compliant report |
| 6. Verification & Validation | Test reports, performance data |
| 7. Clinical Evidence | CER, equivalence, investigations |
| 8. Market Approval | CE, FDA, TGA, etc. |
| 9. QMS | ISO 13485 certificate |
| 10. DoC | Signed by manufacturer |
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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