For entry into the Taiwan market, all medical devices require pre-market approval. The medical device market is growing in Taiwan, but getting into the nation requires strict adherence to regulations set forth by the Taiwan Food and Drug Administration (TFDA). Manufacturers must register their products with the Taiwan Food and Drug Administration (TFDA) to sell […]
Read More →Regulatory oversight is crucial for ensuring the safety and efficacy of Software as a Medical Device (SaMD) solution. Understanding global regulations is essential for developers to navigate risk classification, quality management, post-market surveillance, and international standards, thereby ensuring compliance and fostering innovation in healthcare digitalization. SaMD presents a range of advantages that are reshaping the […]
Read More →For medical device companies looking to enter the Singapore market, the registration process can be complex and time-consuming. However, it is a necessary step to ensure compliance with regulatory requirements and bring products to market. The medical device industry in Singapore has seen significant growth in recent years. The market is driven by a number […]
Read More →Medical device regulations vary from country to country, and this is not different in Japan. To register your medical device in Japan, you need to look for these top 6 considerations to make your registration process easy. Japan is a global economic powerhouse with one of the largest medical device markets. In terms of US […]
Read More →Medical device registration is a mandatory requirement in Myanmar for companies seeking to market and distribute medical devices. The process involves submitting detailed documentation, including technical specifications, safety data, and evidence of compliance with local regulations. Myanmar offers tremendous business opportunities for U.S. exports of medical devices, equipment, and supplies. Myanmar’s private health sector depends […]
Read More →The medical device market has grown significantly in recent years. Recent estimates suggest that the global market for medical devices will reach $612.7 billion by 2025. However, competition is fierce, and medical device companies of all sizes have questions about where and how to register their device. The information in this article was last updated […]
Read More →The Medical Device Control Division (MDCO) from the office of the Food and Drug Administration (FDA) in Thailand (also known as the Thai FDA) oversees Medical device regulations. Recently the Thai FDA has made many changes in regulatory requirements and the approval process for medical devices. This article was last updated in March, 2023. Medical […]
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