Oct 2, 2015

The Health Sciences Authority, Singapore’s medical device market regulator, has published a new risk classification tool for medical devices and IVDs.

The online tool utilizes the HSA's GN-13 rules for medical devices and GN-14 rules for IVDs, both of which are based on guidelines from the Global Harmonization Task Force, the predecessor organization of the International Medical Device Regulators Forum (IMDRF).

The HSA has made the new tool available for “general guidance” only, and recommends verification of classification results with a particular device’s owner, and/or with the HSA's Medical Device Branch for clarification. 


  • Stewart Eisenhart