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Medical Devices-Asia and ROW Regulatory News-Oct. 2023

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  • The intended purpose of the product taking into account the way the product is designed and/or presented. If the intended purpose fits the MD definition in the First Schedule of Health Products Act (HPA), then it would be subject to control as a medical device in Singapore.
  • The primary mode of action by which the intended purpose is achieved.
  • 80272 EQUIPMENT – Class I and II Medical Software Notification
  • 80273 EQUIPMENT – Medical Software Family Registration
  • 80274 EQUIPMENT – Medical Software Registration
  • 80298 IVD – Class II product notification with non-embedded software (SaMD) for dedicated use
  • 80299 IVD – Product registration with non-embedded software (SaMD) for dedicated use
  • To include software (SaMD) for dedicated use as an accessory in IVD product processes.
  • To change the version (new indications and functionalities) of software (SaMD) for dedicated use that is regulated as an accessory in IVD product processes.