Cybersecurity risks are now heightened by medical devices which are connected via the Internet and Intranet in hospitals and home networks. The Cybersecurity Agency Scheme for Medical Devices rates each device according to its cybersecurity risk. This scheme includes four designations of... Read More
Although Singaporean medical practitioners were allowed to import unregistered medical devices for use on their patients with approval from the HSA, there have not been specific guidelines on this issue until this August. According to this recently issued guideline from the Health... Read More
Last month, Singapore’s HSA provided a draft guideline on LDTs. This guideline stated that LDTs used as IVDs or for RUO are not classified as LDTs. LDTs are tests that are only developed and used by labs at their own sites. Labs... Read More
Singapore’s cybersecurity head, Mr. David Koh, said it will increase its cybersecurity approach via a new labeling plan and reinforce its operational technology platforms. Devices that track personal data and have the ability to collect, store, and process such data would be... Read More
As software as a medical device (SaMD) gains significant traction in Singapore, the HSA has recently issued Guidelines on the Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software. This guideline, which references the International Medical Device Regulatory Forum’s (IMDRF)... Read More
Digital healthcare trends are flourishing in Asia due to its aging population, shortage of healthcare personnel, increasing consumer demand, and technological innovation. According to statistics from Graphical Research, the digital health market in Asia Pacific is expected to grow by 33% from 2020... Read More
Singapore’s Health Science Authority (HSA) recently announced regulatory updates pertaining to the two Special Access Routes GN-26 and GN-27. GN-26 allows licensed healthcare providers to import unregistered medical devices to use on their patients. GN-27 allows licensed importers to import unregistered medical... Read More
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guarantee the safety of medical devices that enter its markets, the country’s health regulatory authority has released draft guidance on labeling requirements for key categories of devices.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