Preparing for Class D medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) requires a comprehensive understanding of the regulatory framework and careful preparation of technical, administrative, and quality documentation. Since Class D devices pose the highest risk (e.g., implantables, life-support devices, high-sensitivity IVDs), the pre-submission preparation must be rigorous to avoid delays or rejection.

Below is a detailed guide to the preparation steps and required items before applying:

✅ 1. Confirm Device Classification as Class D

🔍 Use these references:

• GN-01 (for general medical devices)

• GN-02 (for IVDs)

• TR-003 / TR-006 (technical references for classification)

Class D includes:

• Implantable or life-sustaining devices (e.g., pacemakers, defibrillators)

• In vitro diagnostics for high-risk conditions (e.g., HIV, blood group typing)

✅ Action: Document rationale for Class D classification.

✅ 2. Appoint a Local Responsible Person (LRP)

The LRP is the only party permitted to submit MDACS applications on behalf of foreign manufacturers.

LRP responsibilities:

• Acts as the regulatory liaison with the Department of Health (DoH)

• Maintains the technical documentation in Hong Kong

• Coordinates vigilance reporting, recalls, and post-market surveillance

✅ Action: Ensure your chosen LRP is a legally registered entity in Hong Kong and has experience with MDACS.

✅ 3. Obtain Regulatory Approval in GHTF Market(s)

Hong Kong’s MDACS requires that your device is already registered or approved in one or more GHTF/IMDRF markets, such as:

✅ Action:

• Prepare Certificate of Free Sale or equivalent

• Collect copies of registration certificates

✅ 4. Ensure Manufacturer Has ISO 13485 Certification

The manufacturer must hold a valid ISO 13485:2016 certificate for the product and manufacturing site(s), issued by a recognized Notified Body or Certification Body.

✅ Action:

• Ensure certificate is valid and in English

• Include the certificate in the submission package

✅ 5. Compile Complete Technical Documentation

You will need to prepare a technical dossier that demonstrates compliance with the Essential Principles of Safety and Performance.

✅ Action:

• Organize documents in PDF format

• Use clear filenames (e.g., Risk_Management_ISO14971.pdf)

✅ 6. Prepare Labeling and Instructions for Use (IFU)

All labeling must be available in English and/or Traditional Chinese and must include:

• Device name, model

• Manufacturer and LRP details

• Intended use and indications

• Warnings, contraindications

• Sterility, shelf life, lot/serial number

• CE or FDA regulatory statement (if available)

✅ Action:

• Design and finalize product packaging artwork

• Confirm labeling complies with GN-07

✅ 7. Draft Essential Principles Checklist

The checklist demonstrates how your device meets each applicable Essential Principle in GN-01 (MDs) or GN-02 (IVDs).

✅ Action:

• Fill out the official Essential Principles Checklist

• Cross-reference each principle to supporting evidence in the tech file

✅ 8. Create the Manufacturer’s Declaration of Conformity

This is a formal declaration from the manufacturer that the device:

• Meets all applicable Essential Principles

• Complies with relevant standards

• Is safe and effective for its intended use

✅ Action:

• Use official MDACS format for the declaration

• Ensure it is signed and dated by authorized person

✅ 9. Register for and Access the MDIS Portal

The application is submitted through the Medical Device Information System (MDIS) online platform.

✅ Action:

• Ensure LRP is registered on MDIS

• Organize all documents in a format ready for upload

• Validate PDF file sizes and naming conventions

✅ 10. Prepare Vigilance and Complaint Handling SOPs

Post-market surveillance obligations require the LRP to:

• Monitor adverse events

• Respond to field safety actions

• Maintain complaint logs

✅ Action:

• Draft or review internal SOPs for:

  • AE reporting (based on GN-10)

  • FSCA and recalls (based on GN-11)

  • Complaint management

✅ 11. Schedule Internal Review of Submission Package

Before submission:

• Perform an internal audit or third-party pre-review

• Check for missing items, inconsistencies, or outdated documents

• Prepare cover letter summarizing device, classification, and GHTF approvals

📌 Summary Checklist: Pre-Application Preparation for Class D MDACS

Would you like an editable checklist, document templates, or a submission timeline tracker tailored for your specific Class D device? I can generate that for your regulatory team upon request.

Contact Us：

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