News & Articles

In the ever-evolving healthcare landscape, managing change notification to registered medical devices is critical to maintaining their safety and performance in accordance with Essential Principles Checklist of Standards claims. With regulations becoming stricter, manufacturers and stakeholders need a clear understanding of the necessary procedures involved in handling updates, modifications, and post-registration changes. This article breaks […]

The medical device sector in Singapore has experienced remarkable growth, driven by the nation’s favourable business environment, robust intellectual property protections, and expanding healthcare demands. However, navigating the high standards and stringent regulatory requirements can be challenging. A thorough understanding of the medical device registration process, together with guidance on HSA registration and regulatory support, […]

In the world of healthcare, regulatory compliance is the foundation upon which patient safety and industry integrity are built. That is why when it comes to introducing a medical device to the Singaporean market, there are stringent demands of regulatory compliance to ensure utmost safety, reliability and efficacy.  In this blog, we delve into the […]

This is a rather short article to share about the definition and published list of borderline medical device that might be supportive for your regulatory intelligence exercise. A borderline medical device might have some features of a medical device which is to diagnose ,treat or prevent a symptoms or diseases  and possibly  contain  agent or […]