Continuing its efforts to encourage innovation in the medical device market while raising standards, China is considering revoking its requirement that medical devices be tested only in testing centers certified by the National Medical Products Administration (NMPA). But it is uncertain whether... Read More
Seeking to bolster enforcement of its pharmaceuticals market while still accelerating the entrance of innovative drugs and vaccines, the Chinese government has drafted structural changes to its drug and vaccine standards. The draft changes to the Drug Administration Law and the Vaccine... Read More
Seeking to speed the integration of its medical device industry with the international market, China’s National Medical Products Administration (NMPA) is implementing a pilot system for identifying medical devices. The Unique Medical Device Identification system is a set of alphanumeric and linear... Read More
As China pushes the development and use artificial intelligence to ease its chronic shortages of doctors and healthcare facilities, it is moving rapidly to lay down a regulatory framework for the emerging field. In March, China’s National Medical Products Administration established a... Read More
Several months ago, the State Council began to work on setting up the pilot Beijing MAH system for medical devices. Shanghai, Shenzhen and Tianjin have already set up their own pilot MAH systems in 2017 and 2018. Prior to the implementation of... Read More
Beginning to put teeth to its promise of increased scrutiny of how medical devices are manufactured and sold, the Chinese government in April began requiring device firms to submit internal audits to regional regulators. The new requirement issued by the National Medical... Read More
As the number of diabetes patients continues to rise in China, so does the prevalence of end-stage kidney disease—and the demand for dialysis treatment. According to a report released in April by the National Institute of Health Data Science at Peking University,... Read More
Seeking to encourage pharmaceutical companies to market urgently needed new drugs already approved in the United States, China’s National Medical Products Administration (NMPA) is waiving the requirement for clinical trials on 30 such therapies. The list published by the NMPA on March... Read More
China is expected to update its list of medicines covered by government medical insurance plans in June, dropping some drugs with low clinical value for innovative treatments that are urgently needed. Authorities are also likely to adjust the prices it pays manufacturers... Read More
This article was originally published on MedTech Intelligence. Driven by rising obesity, lack of exercise and excessive alcohol use, heart disease has become a major health threat in China. That is propelling a need for more diagnostic tests, new devices to treat... Read More