Korea’s Food and Drug Administration (KFDA) and Indonesia’s National Agency of Drug and Food Control (NADFC) recently signed a memorandum of understanding (MOU) on safety and quality standards. This is the first inter-country MOU signed by the Indonesian NADFC. Prior to this... Read More
India’s Ministry of Health (MOH) has renewed its effort to bring a long-pending bill on medical devices to Parliament. The Ministry recently met with the Federation of Indian Chambers of Commerce and Industry (FICCI), the Association of Indian Manufacturers of Medical Devices... Read More
A recent study done by the researchers at the Chinese Center for Disease Control (CDC) and the University of North Carolina at Chapel Hill (UNC) has shown that child diabetes rates in China are four times higher than in the US. In... Read More
The State Food and Drug Administration (SFDA) of China requires all imported medical devices to bear labels in Chinese before entering China. If a foreign medical device does not have Chinese on its label, it will not be allowed to enter China.... Read More
In June 2012, Taiwan’s Department of Health (DOH) announced that it would allow the sales of low-risk Class I medical devices through “virtual channels” starting July 2012. Virtual channels are any instances in which the medical device cannot be examined by customers... Read More
Japan is the home of one of the oldest populations in the world, causing Japan’s healthcare spending to be extremely high. In order to counter the high expenses, the Japanese government has been pushing the use of generic drugs in an attempt... Read More
High rates of tobacco consumption in China and Japan may lead to a larger demand for cardiovascular devices. China and Japan are the two largest consumers of tobacco products in the world. This causes the rates of cardiovascular disease and the demand... Read More
In April 2012, the Korean FDA (KFDA) made significant changes in its Medical Device Act, which stipulates regulations for medical devices. The revised Medical Device Act improves transparency and predictability for medical device approval. Within the Medical Device Act, the KFDA released... Read More
On May 1, 2012, the Taiwan FDA (TFDA) announced its plan to move towards Summary Technical Documentation (STED). This move is to align with GHTF SG1-N11:2008, Summary of Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of... Read More
The Indian government is planning to restrict drug prices significantly. The Indian government announced that approximately 66% of drugs will be under price limits. Currently, 20% of drugs are under price control. New proposals by the government would extend price controls to... Read More