Grouping medical devices as IVF media
IVF media medical devices with the same product owner that are compatible when used together, and are intended to be used for an IVF procedure and falls within the same IVF Grouping Category.
IVF media grouping requirements
You can group in vitro fertilisation (IVF) media from the same product owner, which are intended to be used together for an IVF procedure category as listed below under one application:
IVF media grouping requirements
IVF media grouping category (closed list) | Examples of media types (non-exhaustive list) |
|---|---|
IVF media of oocyte handling |
|
IVF media for sperm handling |
|
IVF media for zygote handling (processing/media for maintenance of zygotes, etc.) |
|
IVF media for in vitro embryo handling |
|
IVF media grouped together using a specific IVF media grouping, but are of different proprietary or brand names, will be listed separately on the Singapore Medical Device Register (SMDR).
Addition of new models
You can add new IVF media products to an existing SMDR IVF media device listing if the new models:
Fulfil the same device-specific grouping criteria
Have the same device proprietary name
Please submit a Change Notification to make such additions.
A new product registration application has to be submitted for new devices with different proprietary names from those already registered.
