In Hong Kong, medical devices are regulated under the Medical Device Administrative Control System (MDACS) managed by the Medical Device Division (MDD) of the Department of Health. While MDACS is a voluntary registration system, registration is often required for procurement by public hospitals (Hospital Authority) and may become mandatory in the future.

Here’s how to handle Class IV (highest risk) medical device registration under MDACS:

✅ Step-by-Step Guide to Class IV Medical Device Registration

1. Appoint a Local Responsible Person (LRP)

• If the manufacturer is outside Hong Kong, you must appoint a Local Responsible Person (LRP) with a Hong Kong business address.

• The LRP acts as the official representative and handles communication with MDD.

2. Determine Classification

• Ensure the device is accurately classified as Class IV according to the MDACS rules, which align with GHTF/IMDRF guidelines.

• Class IV includes devices that:

  • Sustain or support life

  • Are implanted

  • Present a high risk to the patient if they fail

3. Prepare Supporting Documentation

Provide documentation proving prior market approval in one or more of the following Reference Markets:

• Australia (TGA)

• Canada (Health Canada)

• European Union (CE mark under MDR/IVDR)

• Japan (PMDA/MHLW)

• USA (FDA – PMA or 510(k) depending on the device)

You’ll typically need:

• Proof of reference market approval (e.g. CE certificate, FDA approval letter)

• Technical documentation (e.g. device description, risk management, test reports)

• Instructions for Use (IFU)

• Label samples

• Declaration of Conformity

• Quality system certification (e.g., ISO 13485)

4. Submit the Application to MDD

The application includes:

• Completed application form [MD-APP Form]

• Application fee (currently free but may change in future)

• All supporting documents listed above

Applications are submitted to the Medical Device Division either electronically or in hard copy.

5. Undergo Evaluation

MDD will:

• Review your application and documents

• Request additional information if needed

• Issue a Listing Certificate if approved

6. Maintain Listing

Once approved:

• Ensure that post-market surveillance is in place

• Adhere to reporting obligations (e.g., adverse events)

• Notify MDD of any changes (e.g., labeling, manufacturer address)

📝 Additional Considerations

• Listing Number: Once approved, your device is assigned a Listing Number, which may be required by hospitals and distributors.

• Voluntary Nature: While registration is not legally mandatory yet, it is practically required for market access, especially for high-risk (Class IV) devices.

• Timelines: Review times vary, but expect several weeks to a few months, depending on complexity and completeness of the application.

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