Singapore’s Health Sciences Authority (HSA) has officially opened its new electronic Common Technical Document (eCTD) portal for test submissions. This represents an important move towards the process of digitalizing regulatory submissions for therapeutic products. The eCTD Specification Package version 1.0 will be... Read More
Singapore has quickly become a regional leader in digital health innovation thanks to its strong regulatory frameworks for emerging technologies, including mobile health applications, connected wearables, and AI-enabled devices. As healthcare delivery increasingly makes the transition to digital platforms over the years, the Singaporean Health Sciences... Read More
Singapore’s Health Sciences Authority (HSA) has strengthened international regulatory collaboration through two Memoranda of Understanding (MOUs) signed during the 16th International Conference on Medical Regulation 2025. On September 4, the HSA signed an MOU with Australia’s Therapeutic Goods Administration (TGA) to facilitate... Read More
On July 21, 2025, Singapore’s Health Sciences Authority (HSA) published updated guidance for the risk classification of Software as a Medical Device (SaMD) and qualification of Clinical Decision Support Software (CDSS). The HSA wants to achieve three goals with the updated guidance:... Read More
Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have... Read More
On July 30, 2025, the Singapore Health Sciences Authority (HSA) made some amendments to the regulatory guidance for the registration of therapeutic products. One of the major updates is changes to the submission checklists for New Drug Applications (NDA), Generic Drug Applications... Read More
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.... Read More
The Health Sciences Authority (HSA) is moving Singapore medical device submissions to a new e-platform known as the Singapore Health Product Access and Regulatory E-System (SHARE) effective on July 14, 2025. The new system simplifies application procedures and improves user experience throughout... Read More
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... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More