To apply for Class B medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, certain conditions and eligibility criteria must be met by both the device and the applicant (Local Responsible Person, or LRP).

✅ Conditions and Eligibility Requirements

1. 🔍 Device Classification

• The device must be correctly classified as Class B based on MDACS rules, which align with GHTF/IMDRF guidelines.

  • Class B includes low-to-medium risk devices (e.g., hypodermic needles, surgical drapes, IV catheters, etc.).

  • You must provide a risk classification justification in the application.

2. 🏷️ Prior Regulatory Approval

• The device must already be approved/listed in at least one Reference Market:

  • 🇪🇺 CE Mark (MDD or MDR)

  • 🇺🇸 US FDA 510(k) or PMA

  • 🇨🇦 Health Canada (MDL or MDALL)

  • 🇦🇺 TGA (ARTG inclusion)

  • 🇯🇵 Japan PMDA/MAH approval

• If no reference market approval is available, the applicant must submit a full technical documentation package, including safety, performance, and clinical data.

3. 🏭 Quality Management System

• The manufacturer must operate under a certified QMS, typically:

  • ISO 13485:2016 certified by a recognized body

• The QMS certificate must be valid and relevant to the product’s scope.

4. 📦 Proper Labeling and IFU

• Product labels and Instructions for Use (IFU) must be provided in:

  • English or Chinese (or both)

• Labeling must include:

  • Device name/model

  • Manufacturer name and address

  • LRP information

  • Expiry/manufacture date

  • CE/FDA symbols and regulatory marks (if applicable)

5. 👤 Appointed Local Responsible Person (LRP)

• A Hong Kong-based LRP must be appointed by the manufacturer.

• The LRP must:

  • Be registered with the MDD (submit Form MD-TR)

  • Submit and sign the registration (Form MD1)

  • Handle post-market obligations (adverse event reporting, recalls, etc.)

  • Act as the point of contact between the manufacturer and the Department of Health

6. 📄 Availability of Supporting Documentation

• Required documents must be complete, valid, and consistent, including:

  • Regulatory certificates (e.g., CE, FDA)

  • ISO 13485

  • Declaration of Conformity

  • Device description and classification

  • Labeling, packaging, and IFU

  • Manufacturer's business license (if available)

7. 💰 Payment of Application Fee

• A fee of HK$500 per application must be submitted by cheque payable to:

  “The Government of the HKSAR”

8. 📬 Physical Submission

• Application must be submitted in hard copy to the MDD in Wan Chai.

• No email or online submissions are accepted.

📌 Summary of Key Conditions

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