Singapore’s HSA‘s last update on GN-14 was made in 2018. Now, a new draft was announced on May 2. This document outlines and revises the risk classification of IVD medical devices in Singapore. For example, IVD medical devices that recognize the existence of blood or blood components, organs, or cell tissues that are Class D, also now include any related “derivatives”.
There are also new amendments with respect to software. For example, if the software is implanted into an IVD medical device, it will have the same classification as the IVD medical device. If the software is NOT embedded into a medical device, it will be classified on its own based on this updated GN-14 document.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.