To handle Class C medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must comply with a defined set of regulatory, technical, and administrative requirements established by the Medical Device Division (MDD) of the Department of Health.

Here is a comprehensive breakdown of all requirements for handling Class C medical device registration under MDACS:

✅ 1. Device Classification Requirement

You must first determine and justify that the product is a Class C medical device, as per MDACS classification rules.

🔹 Class C refers to medium to high-risk general medical devices (e.g., anesthesia machines, infusion pumps, diagnostic X-ray systems).

📘 Reference: GN-01: Guidance Notes on Classification System for General Medical Devices

✅ 2. Reference Market Approval Requirement

The device must already be approved, registered, or licensed in at least one reference market:

Accepted reference markets:

• United States (e.g., FDA 510(k), PMA)

• European Union (e.g., CE mark under MDR/IVDR)

• Canada (e.g., Health Canada MDL)

• Australia (e.g., TGA ARTG listing)

• Japan (e.g., PMDA approval)

📌 You must provide supporting certificates and regulatory approvals as part of your application.

✅ 3. Local Responsible Person (LRP) Requirement

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

🔐 The LRP must:

• Be a legally registered entity in Hong Kong

• Register with the MDD using Form MD100

• Be authorized by the manufacturer to act on its behalf (with a formal appointment letter)

• Be responsible for:

  • Submitting the application

  • Communicating with MDD

  • Performing post-market surveillance and adverse event reporting

📄 Supporting documents:

• LRP appointment letter

• Business registration certificate of the LRP

✅ 4. Manufacturer Listing Requirement

The manufacturer must be registered under MDACS using Form MD101, with:

• Manufacturer’s name, address, contact details

• Copy of valid ISO 13485 certificate

• Declaration of Conformity (DoC)

• Scope of manufacture (relevant to the submitted product)

✅ 5. Technical Documentation Requirements

You must compile a technical dossier to demonstrate that the device complies with the Essential Principles of Safety and Performance (GN-03).

📑 Required documents include:

✅ 6. Application Form Requirement

You must submit Form MD102 (Application for Listing of a Medical Device) including:

• LRP and manufacturer information

• Product name, classification, model numbers

• Intended use and reference market approval

• List of supporting technical documents

📎 Attach both printed copies and electronic files (USB or CD).

✅ 7. Language Requirements

All documents must be in English or Chinese.
If originally in another language (e.g., Japanese or German), certified translations are required.

✅ 8. Post-Listing Obligations

Once the device is listed, the LRP is responsible for ensuring ongoing regulatory compliance.

📌 Required actions:

• Adverse event reporting (Form MD151)

• Change notifications (e.g., updates to labeling, manufacturer, design)

• Document retention

• Market surveillance and recall actions if necessary

✅ 9. Submission Requirement

Send the full application package (Forms + supporting documents) to:

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

✅ 10. Fees and Timeframe

• MDACS listing is currently free of charge.

• Typical processing time: 4–6 months (varies depending on application quality and completeness).

✅ Summary Checklist of Key Requirements

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