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
In the Asia-Pacific (APAC) region, regulators are taking important steps to shape the future of artificial intelligence (AI) in medical technology. With that progress comes recognition of the usefulness and transformative potential of AI, and the necessity for new levels of oversight.... Read More
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... Read More
The Singapore Health Sciences Authority (HSA) has published updated guidance for its Change Management Program (CMP) Pilot for Software as a Medical Device (SaMD). This program aims to make the regulatory pathways for post-market changes to SaMD more efficient, balancing patient safety with... Read More
Artificial intelligence is transforming healthcare in Asia: improving the quality of care, facilitating operational efficiency, and increasing patient access. For example, the National University Health System (NUHS) in Singapore uses AI to accurately predict how long patients will stay in the hospital,... Read More