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
Over the last 20 years, Western medical device makers have had a boom in device exports to Asia. During that time, most Asian countries’ populations have gotten wealthier, seen more government investment in healthcare, seen new, more and advanced healthcare insurance programs... Read More
Recently, the Singapore Medical Devices Cluster promulgated a draft regulation for a Change Management Program (CMP) for SaMD products – for industry feedback. The discussion for this proposed regulation is from August 26 to October 21. Singapore, being a very advanced healthcare... Read More
Recently, Singapore’s HSA (the Therapeutics Products Branch, Health Products Regulation Group), updated many drug regulations. For new drug applications (NDAs), generic drug applications (GDAs), and major variation applications (MAV-1), companies can expect to receive their first evaluation feedback earlier than before. In addition,... Read More
The Health Science Authority (HSA) of Singapore has released a new guideline to streamline the approval process for next-generation medical devices, which allows manufacturers to leverage data from previously registered devices. Medical devices often undergo enhancements based on real-world feedback and share... Read More
In late March, Singapore’s HSA promulgated a number of updates for the registration of drugs. First, from April 2024, the HSA will look at a pilot program to use e-labeling for pharmacy-only and generally listed therapeutic products – in addition to RX... Read More