Singapore HSA Proposes New Medical Device and IVD Grouping Criteria
The Health Sciences Authority (HSA), Singapore’s medical device market regulator, has issued new draft guidance expanding grouping criteria for medical and in vitro diagnostic devices submitted for registration.
The guidance comprises two documents, one on general grouping criteria applicable to all devices submitted for HSA registration and the second on grouping criteria for specific device types with similar characteristics. Following a comment period, the HSA plans to implement these proposals October 1, 2015.
General device grouping updates
Regulators in Singapore utilize grouping for purposes of device registration as well as for listing in the Singapore Medical Device Register (SMDR), a prerequisite for the legal sale of a device in the country.
The guidance lists the following six grouping categories for HSA registration and SMDR listing purposes:
1.Family: group of devices all from the same product owner, and that all share the same risk classification, intended purpose and manufacturing process
2.System: group of devices from the same product owner that are meant to be used together for a single or common intended purpose
3.IVD test kit: an in vitro diagnostic device with components from the same product owner, and that are intended to be used together for a specific intended purpose (excluding instruments needed to perform an IVD test)
4.IVD cluster: a group of IVD reagents from the same product owner that area all classified as Class A or B, and that share common test methodology
5.Group: two or more devices sold in a single package, and that share a single intended purpose
6.Single: a single device that cannot be assigned to any other device family, system, IVD test kit, IVD cluster or group.
Grouping for specific types of devices
The second part of the new HSA guidance covers new grouping for particular device types; devices that fall into these groups share similar technical characteristics, meaning that Singapore market registrants may group more than one such device into a single submission to regulators.
Groups covering specific device types include the following:
1.Dental group terms (DGT): Class A and B dental medical devices from the same product owner and whose intended purpose falls within a single DGT descriptor
a.Examples: dental composite adhesive kits, dental cusps, dental cement kits
2.Class B hearing aids: Class B hearing aids from the same product owner and sharing the same design type, and that use the same amplification and communication technologies
a.Examples: behind-the-ear hearing aids, in-hear hearing aids
3.Immunochemistry (IHC) IVD reagents: collections of IVD reagents containing antibodies, and that all come from the same product owner; fall under Class B or C classification; are based on IHC methodology, and that fall under a qualifying IHC IVD grouping category
a.Examples: IHC IVD reagents for selective therapy, pathogen markets, immune disorders or hematologic disorders
4.Fluorescence in situ hybridization (FISH) probes IVD reagents: FISH IVD reagents that come from the same product owner; fall under Class B or C classification; are based on FISH methodology; and that fall under a qualifying FISH probe IVD grouping category
a.Examples: pre-natal testing, genetic testing for inheritable diseases, pathogen identification
5.In vitro fertilization (IVF) media: Groups of IVF media from the same product owner, and that are intended to be used together for an IVF procedure
a.Examples: IVF media for Oocyte or sperm handling, IVF media for zygote handling