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
Entering a new international market comes with its own set of challenges and intricacies. The Thai FDA registration process and the Thailand medical device classification process are pivotal points that every manufacturer needs to comprehend and adhere to before entering into the... Read More
Japanese medical technology market entry requires a meticulous process. Japan has a well-structured regulatory framework to ensure the safety, quality, and efficacy of medical devices marketed within its borders. A deep understanding of this regulatory landscape is crucial for manufacturers aiming to... Read More
Entering the pharmaceutical market in China requires a robust understanding of the country’s regulatory framework. China’s drug regulations overview is a complex landscape that is governed by various laws and administrative regulations. For pharmaceutical companies, both local and international, comprehending these regulations... Read More
Japan’s pharmaceutical market has grown in global prominence and has become an essential location for drug development and sales. Understanding the unique Japan drug registration is crucial for international pharmaceutical companies aiming to tap into this market. The Unique Landscape of Drug... Read More