The Health Sciences Authority (HSA) Singapore has published the latest guidance document on the grouping of medical devices for product registration, with details on device specific grouping criteria, in January 2022.
Under the section for device specific grouping of Class B dental medical devices, a description for dental abrasives has been included. A dental abrasive is a device intended to remove excess material or to smooth roughened surfaces of restorations, intra oral appliances and tooth structure for prophylactic and/or treatment applications. Further explanation can be found in the guidance document.
The section on In vitro fertilization (IVF) has more information on the criteria for device specific grouping of IVF media, whereby IVF media products indicated for the same cell types can be grouped in one application.
A new section on device specific grouping for IVD analysers has been added as well.
More details can be found in “Medical Device Guidance – GN-12-2: Guidance on Grouping of Medical Devices for Product Registration – Device Specific Grouping Criteria (Revision 2), January 2022”: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gn-12-2-r2-guidance-on-grouping-specific-(2022-jan)-pub.pdf