Tightening government control over the sale of medical devices, Korea is now setting up an authorized period of time that devices can be offered for sale before their registration needs to be renewed. Under the new rule published by Korea’s Ministry of... Read More
Changes to pharmaceutical registration regulations in China that go into effect on July 1 are designed to bolster safety requirements for clinical trials, encourage the development of generic drugs, limit fraud in clinical data and expedite the pharmaceutical approval process in China.... Read More
If a foreign medical device company does not have its own office in China and does not want to let their distributor register their product there, registration can be done by an independent third-party company (agent) located in China. In all three cases,... Read More
Driven by the urgent need to develop more and better ventilators and other devices to treat Covid-19 patients, South Korea plans to bolster private-sector medical device research in Korea with an infusion of government cash and expertise. The research and development project aims... Read More
As part of its continuing effort to align its regulatory approach to drug registration and regulation with international practices, China is proposing modifications to the way it categorizes pharmaceuticals. The draft plans would be the first restructuring of registration classifications of chemical... Read More
Medical devices marketed and distributed in Singapore have long been subject to strict requirements that mandate any safety hazards associated with their use be reported to government authorities. Now a new online system makes reporting of what is known in Singapore as... Read More
Spurred by the coronavirus crisis, China is moving for the first time to permit first-time medical diagnoses to be conducted online. The move by China’s National Development and Reform Commission (NDRC) is part of a major new push to move many healthcare... Read More
Regulations on in-vitro diagnostic (IVD) products in South Korea that took effect in May establish a broad set of registration requirements as part of a push to improve oversight of their safety and quality. The regulations, the first in South Korea to... Read More
China’s punishing experience with COVID-19 is likely to push forward deep reforms already underway in the nation’s healthcare system, shifting medical diagnosis and treatment away from large hospitals, furthering digitalization and telehealth, etc. That is the conclusion of a new report by... Read More
Moving to better ensure the safety of medical devices available in China, the National Medical Products Administration (NMPA) in April announced it will implement random inspection regimens on the manufacture, management, distribution, and delivery of such devices already on the market. Under... Read More