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What materials are needed for Class C medical device MDACS registration in Hong Kong? How to prepare the application documents?
Release time：2025-06-25 15:38:33 The author: source:
To register a Class C medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must prepare and submit a comprehensive set of materials that demonstrate your device’s safety, performance, and regulatory compliance. The materials must follow the structure laid out by the Medical Device Division (MDD) under the Department of Health.

To register a Class C medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must prepare and submit a comprehensive set of materials that demonstrate your device’s safety, performance, and regulatory compliance. The materials must follow the structure laid out by the Medical Device Division (MDD) under the Department of Health.

📦 Materials Required for Class C MDACS Registration

The submission consists of three categories of documents:

  1. Administrative Forms

  2. Technical Documentation (Dossier)

  3. Supplementary Declarations and Certificates

🔹 1. Administrative Forms

FormPurposeWho Submits
MD100LRP registrationLocal Responsible Person (LRP)
MD101Manufacturer registrationManufacturer (via LRP)
MD102Device listing applicationLRP

✅ Download from: https://www.mdd.gov.hk

🔹 2. Technical Documentation (Dossier)

This should follow the format outlined in GN-02 and demonstrate compliance with the Essential Principles of Safety and Performance (GN-03).

📁 A. Device Overview

  • Device name, model(s), variant(s)

  • Intended use and indications

  • Device classification rationale (confirm Class C)

📁 B. Design and Manufacturing Information

  • Device specifications and materials

  • Engineering drawings, photos

  • Manufacturing process overview

📁 C. Reference Market Approval Documents

  • Regulatory approval certificate(s) from at least one reference market:

    • CE Certificate (MDR/IVDR)

    • FDA 510(k) or PMA approval

    • TGA ARTG entry

    • Health Canada MDL

    • PMDA approval (Japan)

📁 D. Quality Management System Documents

  • ISO 13485 certificate (valid and issued by an accredited CB)

  • Description of QMS implementation at manufacturing site

📁 E. Essential Principles Checklist

  • Use the checklist from GN-03

  • Demonstrate how the device complies with each applicable principle

📁 F. Risk Management File

  • Risk analysis and risk evaluation (compliant with ISO 14971)

  • Summary of risk control measures and residual risks

📁 G. Clinical Evidence

  • Summary of clinical evaluation report

  • Clinical investigation data or literature reviews (if applicable)

  • For well-known devices, equivalence-based evidence may suffice

📁 H. Product Labeling & IFU

  • Outer and inner packaging labels

  • Instructions for Use (IFU) or user manual

  • Labels and IFU must be in English or Chinese

📁 I. Declaration of Conformity

  • Signed by the manufacturer’s authorized representative

  • Must state compliance with recognized standards and Essential Principles

📁 J. Product Description Brochure

  • Optional but helpful in providing a visual understanding of the product

🔹 3. Supplementary Declarations and Certificates

  • Letter of Authorization from the manufacturer appointing the LRP

  • Business Registration Certificate of the LRP (Hong Kong-registered entity)

  • Summary of changes if any variation of a previously approved model is submitted

🛠️ How to Prepare the Application Documents

✅ Step-by-Step Document Preparation Workflow

StepAction
1️⃣Collect regulatory approvals from reference market(s)
2️⃣Obtain valid ISO 13485 certificate for the manufacturer
3️⃣Complete and sign Forms MD100, MD101, and MD102
4️⃣Build the technical dossier according to GN-02 structure
5️⃣Fill in the Essential Principles Checklist (GN-03)
6️⃣Translate IFU and labels to English or Chinese (if not already)
7️⃣Prepare Declaration of Conformity signed by the manufacturer
8️⃣Compile hardcopy and digital copy (on USB/CD)
9️⃣Organize documents with section dividers and a document index
🔟Submit full package to:

Medical Device Division (MDD)
Room 3101, 31/F, Hopewell Centre, 183 Queen’s Road East, Wan Chai, Hong Kong

📋 Document Formatting Tips

  • All files should be clearly labeled and indexed

  • Use section headers and a table of contents

  • USB/CD file names must match printed document titles

  • Ensure consistency across forms, technical specs, and labeling

  • Include version control and revision dates on documents

⚠️ Key Precautions

ItemWhy It Matters
✅ Reference market approvalWithout this, MDACS will not accept the application
✅ Labeling languageMust be in English or Chinese to be valid
✅ Manufacturer authorizationLRP cannot submit without formal appointment
✅ Technical completenessMissing documents will delay the review or cause rejection
✅ Respond to MDD queries promptlyDelays in response slow down the 4–6 month review window

📌 Summary: Material Checklist

CategoryDocumentRequired
FormsMD100, MD101, MD102✅
AuthorizationLRP appointment letter✅
CertificatesCE/FDA/TGA + ISO 13485✅
TechnicalDossier per GN-02✅
ComplianceEssential Principles Checklist (GN-03)✅
SafetyRisk Analysis (ISO 14971)✅
ClinicalEvaluation report / summary✅
LabelingIFU + labels in English or Chinese✅
LegalDeclaration of Conformity✅
Submission FormatPrinted + USB/CD✅

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Contact Us：

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


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