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
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
The Singapore government has recently been advocating for a newly launched Cybersecurity Labelling Scheme for Medical Devices that will help raise the bar for protection of healthcare data against cyber threats. Launched on October 16, the scheme labels medical devices based on their cybersecurity provisions assessed... Read More
In October 2024, Singapore’s Health Sciences Authority (HSA) updated its Guidance on Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers. From October 1, 2024, evidence demonstrating GMP compliance is mandatory for all new or generic drug applications and minor variations... Read More
In late September, Singapore’s HSA outlined a new eCTD portal program for drugs that will start in early 2025. This is an eCTD portal version 1.0, better than the previous .9 version. This new program will be in a voluntary test phase... Read More