Vietnam imports nearly all the medical equipment and devices used domestically. As such, foreign firms interested in the Vietnamese market must understand the rules and regulations governing the import, sale, and distribution of medical equipment in that market. Although laws have been... Read More
Recent estimates indicate that there are over 3,000 health food products sold on the market in China, including nutraceuticals, functional foods, and products based on Traditional Chinese Medicine (TCM). At least one source reports that total sales volume in China’s health food... Read More
Effective January 14th, Japan’s Ministry of Health, Labour, and Welfare (MHLW) issued new guidelines for medical device packaging. “The Guideline of Package Insert for Medical Devices†aims to provide physicians and consumers with clearer, more comprehensive product and usage information to prevent... Read More
In what many Western observers see as a misguided effort to contain rising healthcare costs, the State Development Planning Commission of China recently revived plans to institute price caps on the drug industry. The new regulations state that manufacturers may sell patented... Read More
Foreign pharmaceutical companies control at least 75% of the local drug market in the Philippines. Foreign firms’ market share is divided between several countries, with U.S. producers accounting for about 10% of the market, and Switzerland, Germany, Australia, France, and the U.K.... Read More
The Korea Food and Drug Administration (KFDA) requires that all medical devices sold in Korea receive approval prior to market entry. In the past, if the foreign manufacturer was exporting to Korea, KFDA regulations stipulated that a local distributor, not the foreign... Read More
Malaysia’s Drug Control Authority (DCA), which was established under the Control of Drugs and Cosmetics Regulations 1984, is a government authority that ensures the safety, effectiveness and quality of cosmetic products marketed in Malaysia. The DCA is responsible for the registration and... Read More
In late September 2001, the Japanese government released an early draft of its new medical industry reform plan. Though it seems unlikely that the plan will be ready by the April 2002 target date, the draft document gives insight into changes likely... Read More
China’s State Drug Administration (SDA), which replaced the State Pharmaceutical Administration of China (SPAC) in 1998, is responsible for supervising the research, production, distribution, and use of pharmaceutics, as well as conducting clinical drug research, monitoring adverse drug reactions, and registering new... Read More
All medical devices sold in Korea must obtain approval from the Korea Food & Drug Administration (KFDA) before they may be sold and marketed in that country. The Medical Devices & Radiation Health Department of KFDA is charged with the inspection and... Read More