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
By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on Medtech Intelligence. The incidence of breast cancer in Asian countries is still small compared to in the United States, but it has tripled in the past three... Read More
By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on MedTech Intelligence. Atrial fibrillation (AF), a life threatening heart disorder, is on the rise among Japan’s aging population, providing opportunities for manufacturers of innovative devices that aim... Read More
By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on MedTech Intelligence. To succeed in Asia, you must know the region, which involves performing extensive primary market research to determine the size and growth rate of your... Read More
By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on MedTech Intelligence. With government support, Chinese companies are investing billions of dollars into genetics research and funding promising new companies at home and abroad. Other Asian economic powerhouses... Read More