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 post, we will provide an overview of China’s NMPA... 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
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 for the production of pharmaceuticals. In China, the GMP is particularly... Read More
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 drug’s safety and efficacy. In this article, we’ll provide a comprehensive guide to... Read More
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 the Chinese NMPA registration process. However, the process can be challenging... Read More
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 process of registering medical devices with the Chinese NMPA can be complex and... Read More
Clinical Evaluation Reports (CER) play a crucial role in the registration of medical products in China. Manufacturers must meet China’s NMPA requirements for clinical evaluation reports to obtain regulatory approval to market their products. A CER report will be used when a... Read More