For Class B medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, the Medical Device Division (MDD) adopts internationally harmonized standards and principles, primarily those from the Global Harmonization Task Force (GHTF) / IMDRF framework.

Here’s a detailed overview of the applicable standards and expectations for Class B medical devices:

✅ 1. Classification Standard

• Devices are classified under GHTF/IMDRF risk-based rules.

• Class B refers to low-to-medium risk devices (e.g., infusion sets, surgical gloves, wound dressings).

📌 Refer to:

• Guidance Notes GN-01: “Definition of Medical Device”

• GN-06: Classification Rules

✅ 2. Essential Principles of Safety and Performance

MDACS follows the GHTF Essential Principles model (similar to EU MDR General Safety & Performance Requirements).

These principles cover:

• General requirements (e.g., safe design, intended use, performance)

• Design and manufacturing

• Labeling and IFU

• Protection against risks (biological, mechanical, radiation, etc.)

📌 Reference:

• GN-02: “Essential Principles of Safety and Performance of Medical Devices”

✅ 3. Quality Management System (QMS) Standards

• Manufacturer must comply with ISO 13485:2016.

• Certification must be issued by a recognized certification body.

✅ 4. Risk Management Standard

• ISO 14971:2019 – Application of risk management to medical devices.

• Risk management report should be part of the technical documentation.

✅ 5. Labelling & IFU Requirements

• Should follow GHTF/SG1/N70:2011 or equivalent.

• Must be in English or Chinese.

• Must include:

  • Manufacturer name & address

  • Product name/model

  • Intended use

  • Warnings/precautions

  • Expiry or manufacture date

  • Batch or serial number

📌 Also see: Guidance Note GN-03 – “Labelling Requirements for Medical Devices”

✅ 6. Product Standards

Depending on the device type, compliance with relevant product-specific international standards is expected. Common ones include:

Note: Standards should be declared in the Declaration of Conformity and test reports provided if available.

📌 Summary Table

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