To apply for Class C medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, several key conditions must be satisfied. These conditions ensure that the device meets the safety, performance, and regulatory standards acceptable by the Medical Device Division (MDD) of the Department of Health.

Below is a detailed summary of the mandatory conditions you must meet before applying:

✅ 1. Correct Classification: Class C Medical Device

Your product must be classified as a Class C device under MDACS based on risk level.

🔸 Definition of Class C

• Medium- to high-risk general medical devices

• Examples: anesthesia machines, dialysis equipment, infusion pumps, diagnostic X-ray machines

📘 Use MDACS Guidance Document GN-01 to determine the class:

GN-01: Classification System for General Medical Devices

✅ 2. Approval in at Least One Reference Market

Before applying, your device must have valid regulatory approval or clearance from at least one reference market.

🔸 Accepted Reference Markets:

📌 Attach proof of approval (certificate, license, listing number, etc.) with your application.

✅ 3. Appointment of a Local Responsible Person (LRP)

If the manufacturer is not located in Hong Kong, a Local Responsible Person (LRP) must be appointed.

🔸 LRP Requirements:

• A legally registered company in Hong Kong

• Officially appointed via a signed letter of authorization

• Responsible for:

  • Submitting and maintaining registration

  • Communicating with the MDD

  • Handling adverse event reporting and post-market surveillance

📄 Must register using Form MD100

✅ 4. Manufacturer Listing Under MDACS

The manufacturer must be registered in MDACS before listing the device.

Required Documents:

• Form MD101 (Manufacturer Listing Form)

• Valid ISO 13485 certificate

• Manufacturer’s contact details and facility address

• Declaration of Conformity (DoC)

✅ 5. Technical Documentation Prepared per GN-02/GN-03

You must submit a complete technical dossier that demonstrates conformity with the Essential Principles of Safety and Performance.

🔸 Core contents:

• Device description and design

• Risk management file (per ISO 14971)

• Clinical evidence or performance data

• Essential Principles checklist (GN-03)

• Labeling and Instructions for Use (in English or Chinese)

• Proof of reference market approval

• Declaration of Conformity (DoC)

📄 Technical documentation format must follow GN-02

✅ 6. Labeling and IFU in English or Chinese

All packaging labels, product markings, and instructions for use must be in English or Chinese, or both.

🔍 Ensure:

• Content is consistent with reference market use

• No misleading claims

• Proper usage warnings and contraindications included

✅ 7. Compliance with Post-Market Obligations

The applicant (LRP) must be able to handle:

• Adverse event reporting (Form MD151)

• Change notifications (e.g., manufacturer change, label update)

• Recalls or corrective actions if required

• Keeping records of sales and distribution for audit

✅ 8. No Online Submission—Only Physical Application Accepted

MDACS currently requires:

• Hardcopy documents (forms and dossier)

• Electronic version (on USB flash drive or CD-ROM)

All materials must be submitted to:

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

✅ Summary Table: Conditions to Be Met

Contact Us：

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