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
Singapore has a well-structured and rigorous regulatory framework for drug registration, which is overseen by the Health Sciences Authority (HSA) under the Health Products Act (HPA). The HSA is responsible for evaluating, approving, and regulating therapeutic products before they can be supplied... Read More
China’s pharmaceutical and medical device markets are rapidly growing, attracting global attention for their potential. However, navigating the regulatory landscape requires a thorough understanding of the local norms and practices, especially when it comes to compliance with Chinese GMP standards. These regulations... Read More
Entering the medical device market in Indonesia requires a solid grasp of the regulatory framework that governs it. The process of registering a medical device can be intricate due to the various steps and guidelines that must be adhered to. However, with... Read More