The procedures and steps for registering a Class D medical device under Hong Kong’s Medical Device Administrative Control System (MDACS) are systematic and aligned with international regulatory practices. Below is a detailed, step-by-step guide tailored specifically to Class D medical devices—the highest-risk category, which includes life-sustaining, implantable, or critical devices.

🧾 Overview of Class D Medical Device Registration under MDACS (Hong Kong)

• Regulator: Medical Device Division (MDD), Department of Health (DoH), Hong Kong

• System: Voluntary registration under MDACS (but functionally required for public hospitals)

• Device Class: Class D (highest risk)

• Application Mode: Online submission via the MDACS Device Information System (MDIS)

✅ Step-by-Step Procedures for Class D MDACS Registration

🔹 Step 1: Determine Device Classification

Use the official guidance document TR-003 (for general devices) or TR-006 (for IVDs) to determine your device’s classification.
Class D includes:

• Implantable defibrillators

• Heart valves

• Dialysis systems

• Ventilators

• Cardiovascular stents

• Devices in direct contact with the CNS, heart, or circulatory system

👉 Refer to: TR-003

🔹 Step 2: Appoint a Local Responsible Person (LRP)

A Local Responsible Person (LRP) is required if the manufacturer is not based in Hong Kong.
LRP must:

• Be a legal entity registered in Hong Kong

• Represent the manufacturer in front of MDD

• Handle application submission, surveillance, and incident reporting

👉 LRP is a critical point of contact throughout the device lifecycle.

🔹 Step 3: Prepare Documentation (Technical & Regulatory)

You must compile a comprehensive dossier for Class D devices. This includes:

👉 Use the Essential Principles Checklist (GN-01) to demonstrate compliance with safety/performance standards.

🔹 Step 4: Submit Application via MDIS

Since April 2024, all applications must be submitted through the Medical Device Information System (MDIS):

• The LRP creates an account on MDIS: https://www.mdd.gov.hk

• Uploads documentation and submits the MD-1 form online

• No government application fee at this stage (as MDACS is still voluntary)

💡 Note: Paper applications have been phased out since October 2024.

🔹 Step 5: Application Review by Medical Device Division (MDD)

Once submitted, MDD performs the following:

• Verifies completeness of documentation

• Checks overseas approvals and certificates

• May request supplementary information

• May reject incomplete/inaccurate submissions

• May conduct on-site assessment (rare, but possible)

🕒 Expected Review Time:

• Approximately 12–24 weeks, but may vary depending on complexity and completeness

🔹 Step 6: Device Listing Approval

If approved, MDD issues a Listing Certificate and the device is included in the official MDACS Medical Device List.

📌 Key Details:

• Validity: 5 years (renewable)

• Listing includes: device name, LRP, manufacturer, intended use, and classification

🔹 Step 7: Post-Market Surveillance & Compliance

After listing, the LRP must maintain compliance through:

📋 Summary Table

📎 Tips for Success

• Ensure all overseas regulatory approvals are current and valid (e.g., CE, FDA, TGA).

• The Declaration of Conformity should reference MDACS’s Essential Principles.

• Submit Chinese and English labeling/IFU.

• Ensure your LRP is trained in post-market surveillance responsibilities.

• Consider pre-submission consultation with MDD for high-risk innovations.

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