The Class D medical device registration process under the Medical Device Administrative Control System (MDACS) in Hong Kong is a structured and voluntary system administered by the Medical Device Division (MDD) of the Department of Health (DoH). Class D represents the highest-risk category of medical devices (e.g., implantables, life-support equipment, high-risk IVDs), and the application requires a robust technical file, compliance with essential principles, and overseas regulatory approval.

Below is a step-by-step guide to the registration process for Class D medical devices under MDACS:

✅ Overview of the Registration Process

🔷 Step-by-Step Procedure

Step 1: Classify the Device

• Use GN-01 (for general MDs) or GN-02 (for IVDs) to determine the classification.

• Class D includes:

  • Devices that support or sustain life

  • Devices implanted into the human body

  • IVDs for detecting serious infectious diseases (e.g., HIV, HBV, blood grouping)

✅ Action: Document your classification rationale for submission.

Step 2: Appoint a Local Responsible Person (LRP)

• Only a Hong Kong-registered entity can act as the LRP.

• The LRP is responsible for:

  • Submitting the application

  • Communicating with MDD

  • Handling post-market obligations

✅ Action: Formalize a contract between the manufacturer and LRP. Register the LRP under the MDACS framework (LRP application).

Step 3: Prepare Technical Documentation

Prepare a full technical file covering all applicable standards and requirements.

Key Documents Include:

✅ Tip: Follow IMDRF/GHTF documentation structure for Class D.

Step 4: Submit Application via MDIS Portal

• The MDIS (Medical Device Information System) is the online submission platform.

• The LRP must log in and:

  • Fill out the device registration form

  • Upload required documents (PDF format)

  • Pay any applicable administrative fees (note: MDACS is voluntary and currently free in most cases)

✅ Action: Keep digital copies organized and ensure each document is clearly labeled (e.g., “ISO13485_certificate.pdf”).

Step 5: Application Review by MDD

• MDD will conduct:

  • Administrative screening (completeness of submission)

  • Technical review (compliance with essential principles)

• MDD may request:

  • Additional data or clarifications

  • Updated documents (if expired or unclear)

✅ Typical Review Timeline:

• 3 to 6 months for Class D devices

• Longer if the product is novel, or technical files are incomplete

Step 6: Device Listing and Certificate

If approved:

• The device is listed on the MDACS website

• A Listing Number is issued (e.g., MDXXXXX)

• A Letter of Acceptance is sent to the LRP

✅ Note: This is not a marketing authorization under law but serves as recognition of compliance and facilitates hospital tenders and private procurement.

Step 7: Post-Market Obligations

Once the device is listed, you must:

📌 Summary Flowchart of the MDACS Class D Registration Process

text复制编辑[1] Device Classification → [2] Appoint LRP → [3] Prepare Dossier → [4] Submit via MDIS →
[5] MDD Review & Clarification → [6] Approval & Listing → [7] Post-Market Compliance

✅ Optional (but Recommended) Preparations

Would you like a downloadable Class D MDACS registration checklist, editable document templates, or a sample MDIS submission package structure? I can generate them based on your specific device type (general or IVD).

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