The Singapore Health Sciences Authority (HSA) has broadened its Singapore Health Product Access and Regulatory E-System (SHARE) to cover Class 2 Cell, Tissue, and Gene Therapy Products (CTGTP) as well as dealer licensing and certification applications. Starting February 10, 2025, stakeholders can use SHARE to better handle their regulatory submissions. SHARE was originally introduced in October 2024 to enable CTGTP registration. With the new extension, the platform now enables users to submit applications for CTGP dealer licenses, apply for Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) certificates for CTGP, and also monitor the status of their certification and licensing.
Singapore’s Medical Devices Cluster (MDC) recently released a draft guideline titled “Best Practice Guide on Medical Device Cybersecurity” and is now seeking public opinion. The proposed guide will serve to recommend actions that will help better secure medical devices and associated processes throughout their Total Product Life Cycle (TPLC). At the pre-market stage, manufacturers should develop built-in cybersecurity measures during product development. In the post-market stage, management includes dealing with risks throughout their TPLC, specifically maintenance, support for aging devices, and legacy system risk mitigation. Comments and feedback on the draft should be filed by May 13, 2025 through the official online portal. The period for stakeholder input begins on March 10, 2025 and closes on May 12, 2025. All required submissions and responses should be made through the designated template available on the official online portal.
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.