To learn more about how PBM can help you register your drug products in Singapore, please contact us. Introduction An island nation of 5.4 million people, Singapore is considered one of the most developed pharmaceutical hubs in Asia. With its current market size... Read More
In the past, API regulations in Singapore have been governed by the Poisons Act 1938 and the Medicines Act 1975. Under the Medicines Act, wholesalers and importers of APIs are recommended to apply for GMP certification, and under the Poisons Act, they... Read More
Singapore’s HSA‘s last update on GN-14 was made in 2018. Now, a new draft was announced on May 2. This document outlines and revises the risk classification of IVD medical devices in Singapore. For example, IVD medical devices that recognize the existence... Read More
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 medical 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... Read More
PBM can help you develop the best regulatory and reimbursement strategies in Asia. Please contact us to learn 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... 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