Singapore: New Revision of the Medical Devices Product Classification Guide

On October 2nd, 2023, the Health Sciences Authority of Singapore (HSA) issued a second revision of GL-06: Medical Device Product Classification Guide. This guidance document is applicable to all medical device dealers namely registrants, manufacturers, importers, and distributors. The main highlights of the updated guidance document include the following:
  1. To include Eye drops or Eye Irrigation Solution (with primary mode of action is physical: lubricating or physical washing) as Medical Device. For example:

    a. Lubricating or moisturising eye drops for relief of dry, irritated eyes.
    b. Eyes drops or irrigation solution for relief of irritated eyes via physical wishing of eyes surfaces.

  2. To include Eye Drops (with primary mode of action via osmosis) as Non-Medical Device. For example: eye drops intended for temporary relief or corneal edema.
  3. To include Emergency Eye Washes as Non-Medical Device. For example: those intended solely for washing of chemical spills / splash.
  4. To include Emergency Skin Washes as a Non-Medical Device (emergency washes for chemical spills/splash).
For further information, please refer here. If you have any queries regarding this announcement, please contact us or click the button below.

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