On May 19, Singapore’s Health Sciences Authority (HSA) started a public consultation on a proposed exemption to the existing regulatory requirements for Artificial Intelligence – Software as a Medical Device (AI-SaMD) that is developed in the public healthcare sector.
Under the Health Products (Medical Devices) Regulations 2010, AI-SaMD products developed in-house by individual healthcare service licensees for their own use are not required to obtain product registration and manufacturer licensing. The exemption is not given to AI-SaMDs that are developed by agencies like the Ministry of Health Office for Healthcare Transformation (MOHT), Synapxe, and other public healthcare clusters, which limits their usage across institutions.
To facilitate a wider adoption of AI devices in the public healthcare sector, the HSA is proposing a new exemption that will allow Class A and B AI-SaMD products created by the MOHT, Synapxe, and other public healthcare clusters to be used in public healthcare without full registration, as long as they meet standards regarding clinical governance, internal governance, and pre-notification to the HSA. This program will operate for 12 months, with the possibility of extensions, and involve post-market surveillance and mandatory yearly self-declaration of compliance with ISO 13485 standards.
Drugs will also be eligible for a 10% reimbursement premium if any of the following criteria apply: use of domestic active pharmaceutical ingredients (API), successful completion of safety clinical trials with globally published results, or the US FDA’s first-to-file Paragraph IV certification with approved marketing authorization.
The NHIA points out that these changes are intended to ensure public access to quality and affordable medicines, to spur local production, and to increase production capacity.
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.