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
In late March, the Philippines FDA (PFDA) has extended the registration date for Class B,C and D medical device registration for devices that were not already on the registrable medical device list. Now, these medical devices do not need to be registered until... Read More
Singapore is an important drug market in Asia. Not because of the market size which is rather small, but because it is the second best overall healthcare market in Asia, after Japan. Getting drug approval and being successful in the Singapore market... Read More
Singapore has the second best healthcare system in Asia after Japan. Thus, as a healthcare leader, Singapore constantly updates its regulations to adapt to new technologies. Singapore is working towards enhancing the cybersecurity and regulatory compliance of medical devices. With the increasing... Read More
According to Singapore’s Regulation 23, when a drug company wants to register a new drug, the Health Sciences Authority (HSA) needs to determine if there is a patent in force. According to the Singapore’s Patent Act 1994, the HSA requires the drug... Read More
Submission of applications to the Japanese authority now mandates usability engineering. The international standard IEC 62366-1, governing usability engineering in medical device development, transitioned into a JIS standard in 2019 and was updated as JIS T62366-1:2022 in February 2022. JIS T 62366-1... Read More