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
Local representatives of foreign medical products firms in Hong Kong will be required to strengthen their procedures for handling, storing and delivering medical devices under new guidelines being proposed by the government. The draft rules on local responsible persons (LRPs), who serve... 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
Moving to give patients faster access to new medicines, the Indian Health Ministry will waive a requirement that new drugs undergo clinical trials in India if they have already been approved in certain other markets. The New Drugs and Clinical Trials Rules,... Read More
Pacific Bridge Medical has just received a verbal message from Hong Kong’s MDCO that a mandatory registration system for medical devices will be put to the Hong Kong Legislative Council later this year and implemented in late 2019 or early 2020. This... Read More