Understanding Risk Classification and Grouping Criteria for Medial Device Registration in Singapore
At ISOGuruSG, we know that navigating Singapore’s Health Sciences Authority (HSA) requirements can feel complex especially when it comes to medical device registration.
Two key steps form the foundation of this process: Risk Classification and Grouping Criteria. Understanding these from the start ensures a smoother, compliant, and more efficient registration journey.
Risk Classification: Your First Gatekeeper
Every registration begins with determining the risk class of your device, guided by:
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GN-13 – Risk Classification for General Medical Devices
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GN-14 – Risk Classification for In Vitro Diagnostic (IVD) Medical Devices
Here’s what it means:
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Class A Devices: Registration not required — must be declared under the Class A exemption list (per GN-22) within the manufacturer/importer licence.
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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:
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GN-12-1 – General Grouping Criteria
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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:
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GN-15: General guidance for all registrations
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GN-17: For General Medical Devices (ASEAN CSDT format)
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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:
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Risk Classification determines if registration is needed.
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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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