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
To learn more about China’s drug approval process, please refer to our webcast. The process of getting a new drug approved in China can be complex and time-consuming. It involves multiple stages of testing and review by regulatory agencies to ensure the... Read More
To learn more about China’s NMPA registration process, please click here. China’s NMPA (National Medical Products Administration) is responsible for China’s medical device regulations. Medical device and In Vitro Diagnostics companies that intend to market their products in China must go through... Read More
To learn more about China’s NMPA registration for medical devices, please click here. Medical devices play a crucial role in modern healthcare, and the Chinese market represents a significant opportunity for companies seeking to expand their sales and manufacturing operations. However, the... Read More
To learn more about China’s clinical evaluation report, please click here. Clinical Evaluation Reports (CERs) are vital for the approval process of medical products in China. Manufacturers must comply with the specific guidelines set forth by China’s National Medical Products Administration (NMPA)... Read More