As the use of artificial intelligence (AI) takes hold in Asia’s healthcare industry, researchers are collecting detailed health profiles of citizens and using the data to test treatments, monitor adverse drug reactions in patients, detect the risk of cognitive issues in children... Read More
Manufacturers of medical devices will be required to take specific actions to eliminate or mitigate potential risks associated with the use of their products already on the market in Singapore, under new regulations published by the country’s Health Sciences Authority (HSA). The... Read More
With computer software increasingly central to the operations of many medical devices, Singapore’s medical authority is developing guidelines designed to ensure the quality of devices sold in the country which employ softwares. A draft of the guidelines released in late January by... Read More
This article was originally published on MedTech Intelligence. Driven by an aging population with growing needs for new medical technologies—and more means to pay for them—governments and hospitals in China, Japan, Singapore, Thailand and Korea are joining forces to purchase an increasing... Read More
Spiraling trade tensions between the U.S. and China are injecting uncertainty into what was already a complex environment for MedTech manufacturers. Accelerating steps, some medical technology firms have already been starting to move their operations to other countries in the region. Directly... Read More
This article was originally published on Medtech Intelligence. Precision medicine, an emerging toolkit of ways to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective, has grown unevenly outside... Read More
In a draft guidance released in September 2019, Singapore’s Health Sciences Authority is seeking feedback from medical device industry stakeholders on the development of new regulations on next-generation sequencing (NGS) in vitro diagnostic devices. The proposed new regulations are limited to devices that... Read More
Seeking to ease access among patients in Singapore to urgently needed life-saving therapies, the Health Sciences Authority (HSA) in September 2019 announced a faster route to the approval of such critical imports. Under the new regulations, licensed hospitals or clinics, retail pharmacies,... Read More
As electronic labeling of pharmaceuticals and therapeutic products becomes more prevalent, Singapore’s Health Science Authority this summer issued guidelines to ensure the labeling systems provide needed information to consumers and regulators. The electronic labels—often dependent on USSD codes that link to labels... Read More
A growing number of Association of Southeast Asian Nations (ASEAN) member states are coming into compliance with medical device requirements they first pledged to work towards in 2015. Under the ASEAN Medical Device Directive (AMDD), the 10 ASEAN nations agreed to bring... Read More