Many global health authorities have already adopted eCTD drug submissions. Singapore too plans to implement this system in the fourth quarter of 2024. To ease the use of eCTD in Singapore, the HSA will broadcast an eCTD regulatory guidance over the next... Read More
By March 3, 2023, Singapore’s HSA has requested industry comments on proposed device labeling for cybersecurity. The draft cybersecurity labeling scheme for medical devices (CLSMD) was initiated in late 2022 by the HSA, MOH, and Integrated Health Information Systems. Today, more medical... Read More
Many drug companies doing clinical studies and product registration in Asia are now looking to add Western CDx’s to make the use of their drug products more effective. Precision or personalized medicine will grow in Asia via CDx’s in the future. CDx... Read More
In January, Singapore’s MOH updated GN-26 and GN-27 SAR for non-registered medical devices. Doctors, medical institutions, and labs can now more easily import non-registered Class D devices that are new or have new indications, or are new implants. Certain categories of non-registered... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
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