To apply for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you must follow a structured process administered by the Medical Device Division (MDD) of the Department of Health. Here's a step-by-step guide to how and where to apply:

📝 How to Apply for Class IV Medical Device Registration (MDACS)

✅ Step 1: Appoint a Local Responsible Person (LRP)

• The LRP must be a legal entity in Hong Kong.

• The LRP is responsible for:

  • Submitting the application.

  • Acting as the point of contact with the MDD.

  • Handling post-market obligations.

✅ Step 2: Confirm Device Eligibility

• The device must be:

  • Class IV (highest risk class under MDACS).

  • Approved in at least one Reference Country:

    • USA (FDA), EU (CE), Australia (TGA), Canada (Health Canada), or Japan (PMDA/MHLW).

✅ Step 3: Prepare Required Documents

• Administrative documents (e.g., Form MD4, Authorization Letter, Reference Market Certificate).

• Technical documentation (e.g., risk analysis, CER, ISO 13485, labeling, IFU).

• See the full list of required documents or request a checklist.

✅ Step 4: Complete Form MD4

• This is the official application form for listing Class II/III/IV devices.

• Must be signed and submitted by the LRP.

✅ Step 5: Submit the Application

📦 Prepare:

• One hard copy of the full application.

• One digital copy (USB or CD-ROM).

📬 Submit to:

Medical Device Division (MDD)
Department of Health
Units 2–3, 11/F, Energy Plaza
92 Granville Road
Tsim Sha Tsui East, Kowloon
Hong Kong

⏳ Processing Time & Fee

• Processing time: Varies; typically 2–6 months depending on completeness.

• Application fee: Currently free (no government fee under voluntary MDACS).

📌 Notes

• Listing under MDACS is voluntary, but required for public hospital procurement and tenders.

• Device listing is non-expiring, but updates must be submitted for any changes (e.g., design, labeling, manufacturer).

Would you like a sample filled Form MD4, authorization letter template, or help preparing your document set?

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