China’s National Medical Products Administration (NMPA) in May published adjustments to its guidelines for clinical trials of medical devices. The changes affect the process of gaining approval for clinical trials of new devices under new requirements, instituted early this year, which mandate... Read More
A growing number of Chinese cities are joining its successful bulk drug purchasing program, which has put pressure on pharmaceutical firms to cut prices since it first went into effect last year. That is likely to decrease market share for individual firms,... Read More
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
Thailand’s Food and Drug Administration is tightening requirements and raising fees for the registration of new drugs. The changes were published in Thailand’s Government Gazette in April as Drug Act (No. 6) B.E. 2562 and go into effect in October, 2019. They... Read More
Easing the path to market for medical devices used in emergencies, Malaysia’s Medical Device Authority (MDA) in April exempted certain devices from registration requirements. The changes, included in a first edition guidance document, “Notification on Medical Devices for Special Access” apply to... 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