Before applying for Class C medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, it’s essential to carry out comprehensive preparations to ensure a smooth application process and avoid delays or rejections.

Here is a detailed guide on all the necessary preparations, including regulatory, technical, and administrative readiness:

✅ 1. Confirm Device Classification as Class C

Hong Kong’s MDACS classifies medical devices based on risk level, following the GHTF framework.

📌 Actions:

• Refer to MDACS GN-01 Guidance Document

• Assess based on:

  • Intended use

  • Invasiveness

  • Duration of use

  • Active/implantable components

🔍 Example Class C devices:

• Infusion pumps

• Diagnostic ultrasound machines

• Surgical lights

• Certain patient monitoring systems

If unsure, consult with a regulatory expert or LRP.

✅ 2. Obtain Reference Market Approval

Your Class C device must be approved or registered in at least one reference market before applying.

✅ Accepted reference markets:

📎 Prepare:

• Valid certificate

• Device listing number

• Free sale certificate (if available)

✅ 3. Appoint a Local Responsible Person (LRP)

If the manufacturer is not based in Hong Kong, you must appoint a Local Responsible Person (LRP) to represent the device legally.

🔹 LRP Requirements:

• Hong Kong-registered company

• Authorized in writing by the manufacturer

• Responsible for:

  • Application submission

  • Post-market surveillance

  • Communication with the MDD

📄 Prepare:

• Form MD100 for LRP registration

• Authorization Letter signed by the manufacturer

✅ 4. Register the Manufacturer with MDD

Before listing the device, the manufacturer must be listed in the MDACS database.

📋 Prepare:

• Form MD101

• Valid ISO 13485 certificate

• Manufacturer's full contact details

• Device production site information

• Manufacturer’s Declaration of Conformity

✅ 5. Prepare the Technical Documentation

This is the most critical step. Documentation must show that the device complies with the Essential Principles of Safety and Performance (GN-03).

🔍 Must Include:

• Device description and classification rationale

• Labeling and Instructions for Use (IFU)

• Risk analysis per ISO 14971

• Clinical evaluation or equivalence

• Biocompatibility, electrical safety, EMC, and performance test reports

• Software documentation (if applicable)

• Essential Principles Checklist (GN-03)

• CE/FDA approval documentation

• Manufacturer’s Declaration of Conformity

📎 Structure must follow GN-02 (Common Submission Dossier Template)

✅ 6. Ensure Labeling & IFU Are HK-Compliant

Labels and Instructions for Use must be:

• In English or Chinese

• Aligned with the reference market usage

• Include:

  • Device name and model

  • Intended use

  • Warnings, contraindications

  • Manufacturer and LRP info

  • Sterility, expiration, and batch number (if applicable)

✅ 7. Plan for Application Packaging & Delivery

MDACS does not support online submission. Applications must be submitted physically.

📁 Prepare:

• One printed copy of all forms and dossier documents

• One electronic version (USB flash drive or CD-ROM)

• A table of contents with labeled sections

📬 Deliver to:

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

✅ 8. Internal Review and Audit

Before submission, conduct an internal audit to ensure:

• No missing sections in the dossier

• All forms are signed and dated

• All test reports and certificates are current and valid

• The device model matches the one approved in the reference market

✅ Summary Checklist: Pre-Submission Preparation for Class C MDACS

Contact Us：

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