Understanding Risk Classification and Grouping Criteria for Medial Device Registration in Singapore

In Singapore, medical device risk classification is governed by the Health Sciences Authority (HSA) and follows a four-tier system: Class A (Low Risk), Class B (Low-Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk). Classification is determined by the device's intended use, duration of contact with the body, and degree of invasiveness, as outlined in the GN-13 guidance. Accurate classification is the most critical step in the regulatory process, as it dictates the registration route (Full, Abridged, or Expedited), the complexity of the technical dossier (CSDT), and the applicable HSA fees. Misclassification can lead to submission rejection or significant market entry delays.

Risk Classification: Your First Gatekeeper

Every registration begins with determining the risk class of your device, guided by:

GN-13 – Risk Classification for General Medical Devices
GN-14 – Risk Classification for In Vitro Diagnostic (IVD) Medical Devices

Here’s what it means:

Class A Devices: Registration not required — must be declared under the Class A exemption list (per GN-22) within the manufacturer/importer licence.
Class B, C & D Devices: Registration is required. Once a device is deemed higher risk, the registration process must be initiated via HSA.

Grouping Criteria — Structuring Your Submission

For Class B, C, and D devices, grouping defines how related products can be bundled into one registration.
Refer to:

GN-12-1 – General Grouping Criteria
GN-12-2 – Device-Specific Grouping Criteria

This helps streamline submissions, reducing administrative effort and improving efficiency.

Documentation & Submission

After classification and grouping are set, documentation follows:

GN-15: General guidance for all registrations
GN-17: For General Medical Devices (ASEAN CSDT format)
GN-18: For IVD Medical Devices (ASEAN CSDT format)

All product registration submissions are conducted via HSA’s SHAREs platform, requiring a CRIS Company Account and a Registrant Account before proceeding.

In short:

Risk Classification determines if registration is needed.
Grouping Criteria define how your submission is structured.

Together, they shape the regulatory roadmap that ensures your medical devices meet HSA’s compliance standards.

If you are planning to register a medical device or set up as a medical device dealer in Singapore, understanding the Medical Devices Registration is your first step toward compliance success.

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