As part of Singapore’s ongoing efforts to guarantee the safety of medical devices that enter its markets, the country’s health regulatory authority has released draft guidance on labeling requirements for key categories of devices. The guidance builds on labeling regulations already in... Read More
Contact us today for a free consultation with an Asia regulatory affairs consultant to discuss your specific needs. This article was originally published on MedTech Intelligence. 3-D printing has revolutionized product customization and digital manufacturing in various industries. In many instances, it... Read More
Government health authorities in Singapore have finalized regulatory guidelines on the manufacture, sale, and distribution of medical devices made using 3D-printing technology. The guidelines, first released in draft form earlier this year, are designed to ensure the products, which are increasingly used... Read More
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