Changes made by manufacturers to software used for medical purposes already on the market in Singapore must be made known to regulators, even if they are considered insignificant, according to new guidance from the country’s Health Sciences Authority (HSA). The direction from... Read More
To ensure that equipment used to analyze in vitro diagnostic (IVD) tests meet Singapore’s current standards for health and safety, regulators in October issued guidance to manufacturers clarifying how best to adhere to the requirements. The Health Sciences Authority (HSA) guidance, designed... Read More
With the use of clinical decision support software (CDSS) proliferating among medical providers, Singapore’s HSA has issued guidance on which types of the software technology are subject to the country’s increasingly strict regulations. The HSA guidance is informational and does not impose... Read More
Advertisements for medical devices are about to come under increased scrutiny in Singapore, with regulators of the wealthy island nation tightening restrictions to ensure the truthfulness of claims made in marketing the healthcare products. New guidance released in September by the city-state’s... Read More
With the use of standalone software as a medical device (SaMD) rising rapidly in Singapore, the country’s health authorities in July unveiled a draft roadmap of regulatory guidelines on software or mobile apps which have a medical purpose and invited public consultation... Read More
Advances in the use of artificial intelligence (AI) are fueling significant improvements in the field of radiology in Singapore, South Korea, and Australia, a new study has found. Eight in ten radiologists surveyed by health data firm Royal Phillips this year... Read More
Eight months after Singapore first announced its plans to establish a Unique Device Identification (UDI) system for medical devices, the country’s health regulatory authority has released draft guidance on how the system will work. According to the guidance, when the system is... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
Moving to clarify and speed the process of registering medical devices in Singapore, the country’s Health Sciences Authority (HSA) has instituted an interactive tool that applicants can use to smooth the entry of products into its strictly regulated market. The tool uses... Read More
The combination of a relatively low–cost workforce and increasingly reliable quality and ethical standards is turning the Asia-Pacific region into a hub for clinical trials. With pharmaceutical firms under growing pressure to provide innovative new products at reasonable prices, the region is becoming more... Read More