Grouping Types
Single
A Single registration covers exactly one medical device — one model, one configuration.
Use when: The device has no variants and is not part of a system or family.
Example: A specific model of infusion pump with one configuration.
Group
A Group registration covers multiple variants of the same device that differ only in minor, pre-specified ways (size, colour, configuration) but share the same:
- Intended purpose;
- Design principles and materials;
- Manufacturing process; and
- Performance and safety characteristics.
Use when: You have a device available in multiple sizes or configurations that are otherwise identical in design and function.
Example: A range of orthopaedic screws available in lengths of 20mm, 25mm, 30mm, 35mm, and 40mm — same design, same materials, different lengths.
HSA's guidance on groups: hsa.gov.sg/medical-devices/registration/grouping/group
Family
A Family registration covers multiple medical devices that share the same intended purpose and are closely related in design, but have more variation than a Group allows — for example, devices in the same product range that differ in design features as well as dimensions.
Use when: Multiple product lines share the same core design concept and intended purpose but differ in more substantive ways than pure size variation.
Example: A range of endoscopes with the same intended purpose (upper GI examination) but in different configurations (different diameters, working lengths, or accessory channel sizes).
HSA guidance: hsa.gov.sg/medical-devices/registration/grouping/family
System
A System registration covers two or more medical devices that are sold, marketed, and intended to be used together as an integrated system, where the components are not intended to be used independently for the same purpose.
Use when: The components work together as an inseparable unit and are always supplied and used together (e.g. a device and its dedicated accessories or software that together achieve the intended purpose).
Example: A blood glucose monitoring system — the meter, test strips, and lancing device that together constitute the system.
HSA guidance: hsa.gov.sg/medical-devices/registration/grouping/system
IVD Test Kit
An IVD Test Kit groups together the individual components that make up a complete IVD test kit: the primary reagent(s), calibrators, controls, and any other components supplied as part of the kit, where all components are manufactured by the same manufacturer and are intended to be used together.
Use when: Registering a complete IVD kit that consists of multiple components sold together.
Example: An HIV test kit consisting of the test strip/membrane, the buffer reagent, and the positive/negative controls.
HSA guidance: hsa.gov.sg/medical-devices/registration/grouping/ivd-test-kit
IVD Cluster
An IVD Cluster groups multiple IVD assays that have the same intended use but are intended to run on different analyser platforms or in different formats (e.g. different sample tube types, or adapted for different laboratory settings).
Use when: The same test methodology has been adapted for multiple platforms but all variants are substantively the same assay.
Example: A Hepatitis C antibody assay adapted for three different open-architecture laboratory analysers.
HSA guidance: hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
IVD Analyser
An IVD Analyser grouping covers multiple models of an IVD instrument (the analyser itself, not the assays it runs) where the models share the same core design, technology, and intended use.
Use when: Registering a range of analyser models that are essentially the same instrument in different sizes or throughput configurations.
Example: A haematology analyser available in a standard-throughput and high-throughput model.
HSA guidance: hsa.gov.sg/medical-devices/registration/grouping/ivd-analysers
Hearing aids
Hearing aids have a dedicated grouping approach. See: hsa.gov.sg/medical-devices/registration/grouping/hearing-aids
Dental grouping terms (DGT)
Dental devices use defined grouping terminology published by HSA. See: hsa.gov.sg/medical-devices/registration/grouping/dental-grouping-terms