To apply for Class C medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must follow a formal application process managed by the Medical Device Division (MDD) under the Department of Health. This process involves document preparation, form submission, and physical delivery to the authority.

📝 How to Apply for Class C MDACS Registration

✅ Step 1: Confirm Classification as Class C

Use the MDD's GN-01 guidance to classify your device:

• Class C includes medium- to high-risk devices, such as infusion pumps, anesthesia equipment, diagnostic imaging devices.

🧠 Reference: GN-01 Classification Guidance

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

If the manufacturer is not based in Hong Kong, an LRP must be appointed to submit the application and fulfill all post-market duties.

📌 Requirements for LRP:

• Must be a Hong Kong-registered entity

• Authorized by the manufacturer via a signed appointment letter

• Must register with the MDD using Form MD100

✅ Step 3: Register the Manufacturer

The manufacturer must be listed under MDACS using Form MD101.

📋 Include:

• Manufacturer contact info

• ISO 13485 certificate

• Scope of manufacturing

• Signed Declaration of Conformity

✅ Step 4: Prepare the Technical Dossier

Structure the technical file as outlined in GN-02, demonstrating compliance with the Essential Principles (GN-03).

📁 The dossier must include:

• Device description

• Intended use

• CE/FDA/TGA/Health Canada/PMDA regulatory approval (at least one)

• ISO 13485 certificate

• Essential Principles Checklist

• Risk analysis (ISO 14971)

• Clinical evidence or equivalence data

• Labeling and IFU (English/Chinese)

• Declaration of Conformity

✅ Step 5: Submit the Application (Form MD102)

Complete Form MD102 for medical device listing and gather all required supporting documentation.

📎 Submission format:

• Printed forms (MD100, MD101, MD102) and dossier

• Electronic copy (on USB drive or CD-ROM) of the entire package

📋 Create a table of contents and clearly label all sections.

✅ Step 6: Submit the Application to MDD

There is no online submission system—you must physically submit the application.

📍 Where to Submit:

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

📞 Tel: +852 3107 8451
🌐 Website: https://www.mdd.gov.hk

✅ Step 7: MDD Review and Listing Decision

The MDD will:

• Review classification and completeness

• Evaluate safety and compliance

• Issue a Listing Certificate and assign a Listing Number if approved

⏱ Review time: Around 4–6 months

📍 Summary: Where & How to Apply

🛠️ Need Help?

I can provide:

• Downloadable templates for MD100/101/102

• Technical dossier structure (Word/Excel)

• Sample Essential Principles Checklist

• List of qualified LRP service providers in Hong Kong

Contact Us：

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