In India, the major sources for pharmaceutical regulation are the Drugs and Cosmetics Act of 1940 (DCA) and the Drugs and Cosmetics Rules (DCR). This legislation applies to the whole of India and all products, whether imported or made in India. The... Read More
Though the government has indicated in the past that it plans to establish a medical device certification system, at present there are no requirements for registration of medical devices in Malaysia. Malaysia does require that FDA, CE mark, or other international approval... Read More
The importation of medical devices that have not yet been approved by the Japanese government falls into two broad categories, based on the purpose of the importation. The first category is for products being imported for personal use by individuals, while the... Read More
Given Japan’s conservative regulatory environment, it should come at no surprise that advertising and promotion of medical devices and pharmaceuticals in Japan is highly regulated and very restrictive. Without shonin, or “approval” of a product, advertising the name, manufacturing process, indications, effects,... Read More
Though most medicine manufactured by foreign joint ventures, large State-owned enterprises, or foreign manufacturers (including imports) is labeled correctly, much of what is manufactured by small domestic producers is not. Product information and labels on locally manufactured products often omits potentially negative... Read More
Once severely restrictive in practice and economically limited, markets in China are beginning to hold brighter prospects for successful entry by foreign manufacturers and suppliers. Medical product companies looking for product import, distribution and manufacturing opportunities in China will find promise in... Read More
Despite the damage from the Asian financial crisis, South Korea’s economy is moving ahead with a surge in imports and increased consumer confidence. The Korean pharmaceutical market is no exception to Korea’s economic boom. The Korean Ministry of Health and Welfare (MHW)... Read More
Clinical trials are essential in monitoring the safety and quality of all pharmaceuticals. Japan's Ministry of Health and Welfare (MHW) and the drug organization (KIKO) are working with the Pharmaceutical and Medical Device Evaluation Center in Japan to guarantee that safety standards,... Read More
China's pharmaceutical market is the second largest in Asia, worth $22.5 billion, and will likely increase upon China's entrance into the WTO. In March 1998, the Chinese government created the State Drug Administration (SDA) to oversee drug importation, improving the enforcement and... Read More
While many countries are experiencing significant increases in medical costs, Taiwan has kept its healthcare expenditures to a minimum and is still able to provide services to over 96% of its citizens. Additionally, Taiwan’s Department of Health (DOH) is working to promote... Read More