Blog Category: Resources

medical device

Singapore Medical Device Registration: Class C Devices

Introduction Singapore’s medical device regulatory framework is considered one of the most transparent and robust systems in the Asia-Pacific region. Managed by the Health Sciences Authority (HSA), the regulatory process aims to ensure the safety, efficacy, and quality of medical devices entering... Read More

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Singapore Medical Device Registration: An Overview

Overview of Singapore’s Medical Device Registration Process The Health Sciences Authority (HSA) of Singapore is responsible for overseeing the registration of medical devices to ensure their safety, efficacy, and quality before they can be marketed and used within the country. The registration... Read More

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Regulation of Software as a Medical Device in Taiwan

Introduction Software as a Medical Device (SaMD) is an evolving sector within the medical device industry, providing essential tools for healthcare applications such as diagnostics, treatment planning, patient monitoring, and telemedicine. Taiwan’s regulatory framework for SaMD is overseen by the Taiwan Food... Read More