Grouping Medical Devices — Overview
What is device grouping?
Device grouping is a Singapore-specific mechanism that allows related medical devices to be submitted and registered together under a single application, rather than as separate individual registrations.
Grouping is a pre-submission decision that must be made before preparing any Class B, C, or D registration application. It affects:
- The scope and structure of the registration dossier;
- Application fees (grouped devices pay a single application fee);
- Annual charges and renewal obligations;
- The scope of any future change notifications — changes to one device in a group may require notification across the whole group.
Why grouping matters
Submitting related devices under the correct grouping type is beneficial when:
- Multiple product variants (e.g. different sizes of the same implant) share the same design, intended purpose, and manufacturing process;
- A system of components is only safe or effective when used together;
- Multiple IVD assay kits share the same technology and risk profile.
Choosing the wrong grouping type (or failing to group when grouping is available) results in unnecessary application fees, duplicated dossier content, and more complex ongoing maintenance.
Grouping types at a glance
| Grouping type | Best for |
|---|---|
| Single | One standalone device with no variants |
| Group | Multiple variants of the same device (different sizes, colours, configurations) with the same intended purpose and manufacturing process |
| Family | Multiple devices with the same intended purpose that are closely related but with some design variation |
| System | Two or more devices that are sold, marketed, and used together as an integrated system |
| IVD Test Kit | IVD components (calibrators, reagents, controls) that form a single complete test kit |
| IVD Cluster | Multiple IVD assays with the same intended use intended to run on different analyser platforms |
| IVD Analyser | Multiple models of an IVD analyser that share the same core functionality |
The grouping tool
HSA provides an online Medical Device Grouping Tool to help applicants determine the appropriate grouping type:
hsa.gov.sg/medical-devices/registration/identifying-md-grouping
Use this tool before preparing any dossier. The grouping decision will be reviewed by HSA during the registration process — incorrect grouping identified at evaluation stage can significantly delay an application.
Grouping and dental devices
Dental devices have a specific set of Dental Grouping Terms (DGT) published by HSA that define how dental device families and groups should be described and bounded. See hsa.gov.sg/medical-devices/registration/grouping/dental-grouping-terms.