From July 14, 2025, Singapore’s Health Sciences Authority (HSA) will enforce a revised version of the guidance document GN-21 to streamline medical device change reporting. Low-risk changes such as label designs, new barcodes, and supplier changes do not need to be reported. Class A devices are now completely exempt from all change submissions. Also, new guidance explains what needs to be done regarding AI-enabled devices, especially when a new application or notice needs to be filed. Other changes include a new requirement (Change Type 6E) for submitting Unique Device Identification (UDI) data, and the elimination of requirements for marketing history for new model additions.
Indonesia’s Ministry of Health has released new regulations specifying the requirements and process for listing medicines and health-related products within Indonesia’s national E-Katalog, the nation’s e-procurement center. The new scheme covers multiple types of prescription and over-the-counter drugs, natural and quasi drugs, health supplements, vaccines, and processed food for special medicinal purposes. To be eligible for listing, manufacturers have to satisfy administrative criteria such as having valid marketing authorization, business category code registration, and agreement of cooperation with approved wholesalers. The new system also emphasizes the use of local content, as products need to meet minimum requirements on the number of domestic components. The new framework aims to simplify the public procurement process and advance the utilization of domestically manufactured medicines.
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.