Medical Device Classification in Singapore: A Risk-Based GHTF Approach

Medical Device Classification in Singapore: A Risk-Based GHTF Approach

The classification of medical devices (MD) and In Vitro Diagnostic (IVD) devices in Singapore is overseen by the Health Sciences Authority (HSA). The system is based on the guidelines established by the Global Harmonization Task Force (GHTF), which ensures a risk-based approach to regulation.

General Medical Device (MD) Classification

Medical devices are categorized into four classes, ranging from the lowest to the highest risk:

• Class A (Lowest Risk): Generally non-sterile, non-measuring devices with minimal potential for harm.
• Class B (Low to Moderate Risk): Devices that pose a low to moderate risk to the patient and user.
• Class C (Moderate to High Risk): Devices that pose a moderate to high risk, often due to longer-term contact with the body or more serious consequences if failure occurs.
• Class D (Highest Risk): Devices that pose the highest risk, typically life-sustaining implants or devices with major public health implications.

Factors Determining Risk Classification

The HSA's classification system considers multiple factors to determine the risk level, including:

• Intended Use: The primary purpose of the device.
• Degree of Invasiveness: Whether the device penetrates the body.
• Duration of Contact: How long the device is intended to be in contact with the patient.
• Delivery Method: How the device is introduced or used.
• Effectiveness of Risk Management: The degree to which risks can be mitigated during design and manufacturing.

In Vitro Diagnostic (IVD) Classification

IVD products are also classified from Class A (lowest risk) to Class D (highest risk). The risk level for IVDs is determined by:

• Intended Use: The purpose of the diagnostic test (e.g., general screening vs. critical diagnosis).
• Importance of Information: The impact of the test result on the individual and public health.
• Expertise of User: Whether the test is intended for professional use or self-testing (home use).

Example: A simple pregnancy test may be Class B, while an HIV blood test is Class D due to the severe public health implications and critical nature of the diagnostic information.

Special Classification Cases

1. Software as a Medical Device (SaMD)

Stand-alone software is classified based on its functionality and relationship to other devices:

• Influencing Other Devices: If the software influences the use of another medical device, its classification is determined by the intended use of the combined products.
• Independent Software: If the software is independent, it is classified according to Singapore's general rules, often as an active device.

2. Aesthetic and Telehealth Devices

• Telehealth Devices: Risk can range from Class A to Class C, depending on the monitoring function. For example, an app that only displays physiological factors is Class A, one that measures a single parameter is Class B, and one that performs continuous measurement (e.g., irregular heart rate) is Class C.
• Aesthetic-Related Purpose: Only high-risk devices intended for the modification of appearance or anatomy are regulated. These include:
  • Any implant for the modification or fixation of any body part.
  • Injectable dermal or mucous membrane fillers.
  • Instruments used for the removal or degradation of fat by invasive means.