D-class medical device registration with the Health Sciences Authority (HSA) in Singapore refers to the regulatory process for registering low-risk medical devices that are intended for use in healthcare settings.

What is a D-Class Medical Device?

In the context of medical devices, Class D refers to devices that are generally considered low-risk. These devices are typically non-invasive and non-sterile, and they do not present a significant risk to the user or patient when used according to their intended purpose.

Key Features of D-Class Medical Devices:

• Low-Risk: The risks associated with the device are minimal.
• Non-Invasive: These devices typically do not enter the body or perform procedures that could cause injury or harm.
• Non-Sterile: Devices that do not require sterilization for their intended use.
• Limited Regulatory Oversight: Compared to higher-risk devices (Class A, B, and C), Class D devices generally require less stringent review and fewer clinical data.

Examples of D-Class Medical Devices:

• Diagnostic equipment (e.g., blood glucose meters).
• Rehabilitation devices (e.g., wrist supports).
• Patient monitoring systems for non-invasive monitoring.

Why Register D-Class Devices with HSA?

• Compliance: Registration ensures that the device complies with Singapore’s medical device regulations and standards set by HSA.
• Market Access: Once approved, the device can be marketed and sold in Singapore, ensuring that it meets safety and performance standards.
• Consumer Safety: Even for low-risk devices, regulatory oversight ensures that they do not harm users and perform as expected.

D-Class Registration Process:

The registration process for D-class devices is typically simpler and faster than for higher-risk devices. It involves:

1. Preparation of Documentation: You need to provide documentation such as product descriptions, risk management files, and manufacturing details.
2. Application Submission: Submit the application through HSA’s online portal, MedReg.
3. Review and Evaluation: HSA evaluates the device’s safety, performance, and compliance with local regulations.
4. Approval and Issuance of Certificate: If the device meets HSA’s requirements, a registration certificate is issued, allowing the device to be marketed in Singapore.

Post-Registration Obligations:

After registration, you are required to:

• Monitor the device’s performance.
• Report any adverse events or issues to HSA.
• Ensure the device complies with local standards and regulations.

In summary, D-class medical device registration in Singapore HSA is a simplified regulatory process designed to ensure that low-risk devices meet safety and quality standards before they are introduced into the Singapore market.