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 category

(closed list)

 Examples of media types

(non-exhaustive list)

IVF media of oocyte handling
  • Oocyte obtaining
  • Oocyte processing
  • Oocyte in vitro maturation
  • Oocyte polar body biopsy
  • Oocyte cryopreservation
  • Oocyte storage
  • Oocyte thawing
  • Oocyte transport

IVF media for sperm handling
  • Semen/sperm obtaining
  • Semen/sperm processing (e.g. gradient, swim up, immobilisation, washing)
  • Semen/sperm cryopreservation
  • Sperm storage
  • Sperm thawing
  • Sperm transport

IVF media for zygote handling (processing/media for maintenance of zygotes, etc.)
  • IVF with insemination
  • IVF with Intracytoplasmic Sperm Injection (ICSI)
  • Zygotes maintenance
  • Zygote intrafallopian transfer (ZIFT)

IVF media for in vitro embryo handling
  • In vitro embryo obtaining
  • In vitro embryo culture and assessment
  • In vitro embryo biopsy
  • Assisted hatching
  • In vitro embryo cryopreservation
  • In vitro embryo storage
  • In vitro embryo thawing
  • In vitro embryo transport
  • Embryo transfer (ET)

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.