Starting from December 1, 2009, Hong Kong has now set up the process to list Class D In Vitro Diagnostic (IVD) Medical Devices under the Medical Device Administration Control System. IVD medical devices are classified in Hong Kong similar to the guidelines... Read More
India’s Central Drugs Standard Control Organization (CDSCO) recently issued the required list of documents needed to conduct bioequivalence studies for export purposes. There have been a growing number of applications filed by manufacturers, importers, and CRO’s requesting approval to carry out BE... Read More
As part of China’s overhaul of its healthcare system, the government has recently released a list of approximately three hundred medicines that are expected to be sold at government-controlled prices starting in September. The list of essential medicines includes Western medicines such... Read More
Hong Kong is now a part of China, but as a special administrative region, Hong Kong has its own medical device regulations separate from China. Having only a few local device manufacturers, Hong Kong imports most of its medical devices. While there... Read More
Chuikyo, Japan’s Central Social Insurance Medical Council, plans to increase the National Health Insurance drug price premium rates for certain drugs. These products include drugs that are innovative, drugs that demonstrate increased usefulness, pediatric medicines, orphan drugs, and kits. The premium rate... Read More
Currently, India has only just begun to address medical devices as a separate regulatory category. Generally, regulation of medical devices is only conducted by officially classifying certain devices as “drugs” and subject to drug laws. Since March 1, 2006 there have been... Read More
India’s Department of Science and Technology (DST) has recently prepared a draft legislation on a regulatory framework for medical devices. Currently, some medical devices are classified as drugs and are regulated by the Central Drugs Standard Control Organization. However, since many of... Read More
Korea is an important Asian destination for foreign medical devices. Its total medical device market in 2005 was about $2.5 billion. While this may seem low compared to China's $5 billion, its health expenditure per capita in 2006 was $705, compared to... Read More
The State Food and Drug Administration (SFDA) in China recently drafted the “Principles of Medical Device Nomenclature” to standardize medical device names. Medical device nomenclature is currently unregulated, which has led to confusion and misrepresentation. Medical devices which are essentially the same... Read More
The Medical Device Control Office (MDCO), part of Hong Kong’s Department of Health, recently made official the Conformity Assessment Framework. This is a framework for new conformity assessment requirements for medical devices and information on Conformity Assessment Bodies (CABs). Hong Kong currently... Read More