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Applying for Class D medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong involves a structured set of regulatory procedures managed by the Medical Device Division (MDD) of the Department of Health (DoH). Class D includes the highest-risk medical devices (e.g. implantable devices, life-supporting equipment, and critical in vitro diagnostic devices), so the process is rigorous.
✅ Full Procedure for Class D Medical Device MDACS Registration
🔹 Step 1: Determine Device Classification
Use the official guidance:
GN-01 (General Medical Devices)
GN-02 (IVD Devices)
✅ Confirm your device is Class D, which typically includes:
Life-sustaining or life-supporting devices
Implantables
High-risk IVDs (e.g. HIV, HBV tests)
🔧 Document your classification rationale to justify your submission to MDD.
🔹 Step 2: Appoint a Local Responsible Person (LRP)
The manufacturer must appoint a Local Responsible Person (LRP) in Hong Kong.
LRP must be:
A company legally registered in Hong Kong
Authorized by the manufacturer via a Manufacturer Authorization Letter (MAL)
Registered with MDD as an LRP under MDACS
LRP is responsible for:
Submitting and maintaining the registration
Communicating with MDD
Handling adverse events, recalls, FSCA
📝 Submit LRP registration form and supporting documents (e.g. HK Business Registration, MAL).
🔹 Step 3: Prepare Technical Documentation
Build a full technical dossier demonstrating compliance with Hong Kong MDACS and international regulatory standards (GHTF, IMDRF, ISO).
Required documentation includes:
| Section | Key Documents |
|---|---|
| Regulatory Approvals | CE Certificate (MDR), FDA 510(k)/PMA, TGA, etc. |
| QMS Evidence | ISO 13485:2016 certificate (valid and in scope) |
| Device Details | Model list, product description, photos |
| Risk Analysis | ISO 14971-compliant risk management file |
| Clinical Data | Clinical Evaluation Report (CER) or performance data |
| Performance & Safety Tests | Biocompatibility, electrical safety, EMC, sterilization |
| Labeling | IFU, primary and secondary labeling (ENG / Traditional Chinese) |
| Essential Principles Checklist | Per GN-01 or GN-02 |
| Declaration of Conformity | Manufacturer’s signed statement |
| PMS and FSCA SOPs | Post-market surveillance procedures (especially for Class D) |
📎 Ensure all documents are up to date and properly formatted (PDF preferred).
🔹 Step 4: Register and Apply via MDIS
Use the Medical Device Information System (MDIS) portal:
Website: https://mdis.mdco.gov.hk
Steps:
LRP logs into MDIS
Select: “Apply for Listing of Medical Device”
Fill in the form with device and manufacturer info
Upload all required documents
Submit application
✅ Ensure each file is labeled clearly and matches the section (e.g., “ISO13485_certificate.pdf”)
🔹 Step 5: Application Review by MDD
The MDD reviews applications in two stages:
| Review Type | Duration | Notes |
|---|---|---|
| Administrative Check | 2–4 weeks | Checks completeness of submission |
| Technical Review | 3–6 months | Reviews safety, performance, clinical, QMS, etc. |
MDD may issue Request for Clarification (RFC) if any issue arises.
📬 You must respond to RFCs within 10–30 calendar days depending on the request.
🔹 Step 6: Listing and Approval
Once approved:
The device is listed under MDACS
A Listing Number (e.g., MD-xxxxxx) is issued
MDD issues a Letter of Acceptance
📌 Listing is valid for 5 years, renewable before expiration.
🔹 Step 7: Post-Market Compliance Obligations
After listing, the manufacturer and LRP must comply with:
| Obligation | Regulation |
|---|---|
| Adverse Event Reporting | GN-10 |
| Field Safety Corrective Actions | GN-11 |
| Change Notifications | Any changes in design, label, manufacturing |
| Renewals | Every 5 years |
| QMS Maintenance | Valid ISO 13485 required |
| FSCA and Recalls | Must report immediately via MDIS |
| Document Retention | At least 5 years for Class D devices |
📌 Use internal SOPs for complaint handling, AEs, and periodic technical updates.
📑 Summary of the Full MDACS Class D Registration Procedure
| Step | Action |
|---|---|
| 1 | Classify the device under GN-01 or GN-02 |
| 2 | Appoint and register a Local Responsible Person (LRP) |
| 3 | Prepare technical documentation and QMS evidence |
| 4 | Submit application via MDIS portal |
| 5 | Respond to MDD clarification requests |
| 6 | Receive listing approval and Listing Number |
| 7 | Comply with post-market obligations and periodic updates |
⏳ Total Estimated Timeline
| Stage | Duration |
|---|---|
| Preparation & LRP registration | 1–2 months |
| Submission & administrative review | 2–4 weeks |
| Technical review & clarification | 3–6 months |
| Listing approval | 1–2 weeks |
⏱ Total average time: 4–8 months, depending on complexity.
Would you like editable templates for:
The MDACS application form
Essential Principles checklist (GN-01/GN-02)
Risk and PMS templates for Class D
Let me know your product type and I can tailor them for you.
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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