Requirements for Class IV Medical Device Registration under Hong Kong MDACS

Class IV devices are considered highest-risk medical devices under the Medical Device Administrative Control System (MDACS) in Hong Kong. While MDACS is voluntary, listing is required for participation in public hospital tenders and is often seen as a mark of compliance with international safety and performance standards.

🔷 Key Requirements for Class IV Medical Device Registration

1. Local Responsible Person (LRP)

• A Hong Kong-based entity or individual must be appointed as the LRP.

• The LRP is the official liaison with the Medical Device Division (MDD) and is responsible for:

  • Submitting the application

  • Holding technical documentation

  • Handling post-market surveillance and incident reporting

• Must register with MDD using Form MD1 before submitting device applications.

2. Reference Country Approval

The device must be approved or authorized in at least one of the following "Reference Countries":

• European Union (CE marking under MDR)

• United States (FDA 510(k) or PMA)

• Australia (TGA listing)

• Canada (Health Canada MDL)

• Japan (PMDA or MHLW approval)

You must submit:

• Valid approval certificate(s)

• Declaration of conformity to applicable standards

• Copy of labeling and Instructions for Use (IFU)

3. Technical Documentation

The device must have complete technical documentation covering:

4. Administrative Documents

You must submit:

• Form MD4 (Application for listing Class II/III/IV device)

• LRP’s business registration certificate

• Letter of authorization from the manufacturer to the LRP

• Product brochures and photos of the device and packaging

5. Labeling and Packaging

• Labels must be in English or Chinese (or both)

• Must include:

  • Device name

  • Model/Reference number

  • Manufacturer’s name and address

  • Instructions for use (IFU)

  • Batch/serial number

  • Expiry date (if applicable)

  • Warnings/precautions

6. No Government Fee (Currently)

• There is currently no application fee for device listing under the voluntary MDACS program.

7. Post-market Obligations

Once listed, the LRP must:

• Report adverse events or incidents to MDD

• Manage product recalls or safety actions

• Update MDD if:

  • There are significant changes to the device

  • New approvals or withdrawals happen in reference countries

📌 Summary Checklist

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