Singapore’s Health Sciences Authority (HSA) is finalizing guidance on medical devices classification for registration purposes. In July, the HSA issued two documents: GN-12-1: Guidance on Grouping of Medical Devices for Product Registration – General Grouping Criteria; and GN-12-2: Guidance on Grouping of Medical Devices for Product Registration – Device Specific Grouping Criteria, and asked ‘stakeholders’ to submit feedback on the documents by August 31st.
GN-12-1 explains how a collection of devices may be incorporated into a single product registration. The updated guidance clarifies and expands grouping criteria for a family. GN-12-2 clarifies grouping criteria for certain specific device types. These device types have been noted to possess certain specific attributes and thus similar technical characteristics that allow them to be grouped into one product registration submission.
The HSA will apply grouping criteria outlined in the documents immediately after incorporating stakeholders’ comments. The guidance documents can be found at: Singapore HSA Guidance Documents on Medical Device Classifications for Product Registration