Singapore’s Health Science Authority (HSA) recently announced regulatory updates pertaining to the two Special Access Routes GN-26 and GN-27. GN-26 allows licensed healthcare providers to import unregistered medical devices to use on their patients. GN-27 allows licensed importers to import unregistered medical devices for use in public health institutes (PHIs). Starting from April 1, 2022, for unregistered Class D medical devices that are either unregistered implants or new technologies and state-of-the-art products for clinical use, PHIs are now required to complete the Clinical Justification Review Form, which will be reviewed by the Ministry of Health. The update also stipulates that once a GN-27 license for a medical device expires, the medical devices that are already in use can no longer be used and distributed until a new application for the remaining units is filed. This update is part of the HSA’s continuous effort to ensure the safety and efficacy of unregistered medical devices used by licensed healthcare providers and PHIs.
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.