South Korea has long stood at the forefront of technological advancement in Asia, with a robust healthcare system and a rapidly growing digital health ecosystem. In line with its reputation as a global innovator, South Korea has recently introduced several major regulatory... Read More
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
Malaysia has developed a robust and evolving regulatory system to govern the safety, efficacy, and quality of medicinal products. At the core of this system is the 1984 regulation – Control of Drugs and Cosmetics Regulations (CDCR). These regulations set the legal... Read More
Malaysia’s healthcare sector continues to grow rapidly, supported by a robust regulatory environment aimed at ensuring the safety, quality, and performance of medical devices. Central to this framework is the Medical Device Act 2012 (Act 737. Under this Act, all medical devices... Read More
The Drug Master File (DMF) system in Japan serves as a critical regulatory mechanism enabling pharmaceutical manufacturers, both domestic and foreign, to confidentially register the quality and manufacturing data of drug substances, intermediates, and related materials with Japan’s review authority. Managed by... Read More
Navigating regulatory landscapes can be daunting, especially when dealing with proprietary drug substance information. For pharmaceutical companies planning to register therapeutic products in Singapore, understanding the requirements of a Drug Master File (DMF) is essential. In August 2024, Singapore’s Health Sciences Authority... Read More
Introduction Regenerative medicine is an innovative and rapidly evolving field that leverages genes, cells, and their derivatives to reconstruct or repair human body structures and functions, ultimately aiming to treat or prevent diseases. This field has the potential to revolutionize healthcare by... Read More
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
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
Definition of Combination Products in Taiwan Combination products are classified based on the “Key Points for Combination Product Determination.” These products fall into two main categories. The first category includes a single product that integrates pharmaceuticals and medical devices, where the components... Read More