To learn more about Japan’s PMDA, please click here. The Pharmaceuticals and Medical Devices Agency (PMDA) is the governing body for medical device approval in Japan. It holds the reins of the industry and dictates the rules of the game. One critical... Read More
To learn more ahout medical device labeling requirements in Japan, please click here. The labyrinth of medical device labeling requirements, especially in international markets like Japan, can be daunting. Comprehending and complying with these prerequisites form a critical part of the Japanese... Read More
To learn more about Japan’s medical device regulatory framework, please click here. The global medical device industry is a dynamic, rapidly evolving sector, responsible for developing and distributing critical healthcare equipment worldwide. From diagnostic tools to surgical instruments, medical devices play a... Read More
To learn more about Japan’s CDx market, please click here. The concept of one-size-fits-all medical treatment is gradually being replaced by more precise approaches. This transition has been primarily facilitated by the rise of companion diagnostics. One country at the forefront of... Read More
A Japan companion diagnostic test provides vital information about a patient’s likely response to a particular drug, optimizing therapeutic efficacy, and minimizing adverse reactions. Therefore, venturing into Japan’s CDx market is an attractive prospect for many international In Vitro Diagnostics (IVD) and... Read More
To learn more about medical device sourcing in Asia, please click here. Medical device sourcing in Asia has become increasingly popular due to the region’s low labor costs and skilled workforce. However, sourcing medical devices in Asia presents unique challenges that must... Read More
To learn more about Asian medical device procurement, please click here. Asia has become a key player in the global medical device industry. With this growth, Asia medical device sourcing has become an essential aspect of many healthcare organizations’ supply chain strategies.... Read More
To learn more about China’s NMPA, please click here. China’s National Medical Products Administration (NMPA) is responsible for regulating medical devices and drugs in China. Its classification system is an important part of the regulatory process for these products. In this blog... Read More
As global demand for medical devices continues to increase, businesses are expanding their operations to tap into the booming Asian market. Exporting medical devices to Asia comes with its unique set of challenges, particularly in the realm of regulatory compliance. In this... Read More
For more information on China GMP, please refer to this article. The pharmaceutical industry is highly regulated worldwide, ensuring that the products manufactured meet stringent quality and safety standards. One such standard is the Good Manufacturing Practice (GMP), which outlines the requirements... Read More