HSA issues updated guidance on Grouping of Medical Devices for Registration
The Singapore Health Sciences Authority (HSA) has issued updated Guidance on the Grouping of Medical Devices for Registration (GN12-2 revision 2). This concerns:
- Dental Medical Devices of Class B only which wish to apply for registration using dental grouping terms. Applicants may group their dental devices using GN-12-1 or this latest version of the guidance, GN-12-2-r2. Please note that this is not applicable to Class C or Class D dental devices.
- Device-specific grouping of In Vitro Fertilization Media where IVF media products must fulfill the following criteria for grouping in order to submit an application for a single registration:
- From same product owner
- Indicated for the same cell type(s) e.g., all models for oocyte handling or all models for both oocytes and sperms handling.
For more information, please refer to GN-12-2-r2: Guidance on Grouping of Medical Devices for Product Registration – Device Specific Grouping Criteria Revision 2 (pub Jan 2022).
Please note another regulatory guidance update from the HSA: GN-15 revision 8 of Guidance on Medical Device Product Registration which expands the type of approvals from the US Food and Drug Administration and the European Union EC Certificate Notifying Bodies. Click here to read more on GN-15 revision 8.
Registering medical devices in Singapore:
To learn more about registering medical devices in Singapore click here.
To learn more about the medical device market in Singapore click here.
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