In Hong Kong, medical device registration is overseen by the Medical Device Division (MDD) of the Department of Health, under the Medical Device Administrative Control System (MDACS). Though registration is voluntary (as of now), it is strongly recommended, especially for public procurement and private healthcare institutions.

Here’s how to handle Class A (low-risk) medical device registration under MDACS:

✅ Step-by-Step Process for Class A Medical Device Registration under MDACS:

1. Determine Classification

Ensure your product falls under Class A per the Guidance Notes GN-01:

• Class A typically includes non-sterile, non-measuring, and non-reusable surgical instruments, e.g., tongue depressors, wheelchairs (manual), thermometers (non-electronic), etc.

2. Appoint a Local Responsible Person (LRP)

If you're a foreign manufacturer, you must appoint a Local Responsible Person (LRP) based in Hong Kong to act on your behalf.

• The LRP must be registered with the Medical Device Division.

• Responsibilities include: product registration, communication with MDD, complaint handling, and vigilance reporting.

3. Prepare Required Documents

For Class A devices, the document requirements are lighter than for Class B–D. You'll generally need:

• Product Description and intended use

• Manufacturer’s details

• Labeling and Instructions for Use (IFU)

• Conformity assessment evidence, e.g.,:

  • CE Declaration of Conformity

  • FDA 510(k) clearance

  • ISO 13485 certificate of the manufacturer

• Device classification rationale

Reference: Guidance Notes GN-02 – Device Listing Requirements

4. Submit Application to MDACS

• Submit the application form MD-TRF for listing of Class A Medical Device.

• Applications are submitted by the LRP to the Medical Device Division.

5. Review and Listing

• The MDD will review your application.

• If all criteria are met, your device will be listed on the Medical Device Administrative Control System (MDACS) website.

⏳ Typical timeline: 1–3 months for Class A if documentation is complete.

🔍 Key Points

📌 Tips

• Use reference country approvals (EU, US, Canada, Australia, Japan) to support your application.

• Even if Class A devices are not subject to rigorous review, maintaining quality documentation and post-market surveillance is important.

• MDACS listing increases your credibility in the market and is often required for hospital tenders.

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