The Asian medical market is facing rapid changes as modernization greatly enhances the development of new and improved medical devices. Japan's recently revised Pharmaceutical Affairs Law (PAL) has maintained its basic purpose since 1948: to guarantee safety, efficiency and quality of medical... Read More
One of the main revisions of the Japanese Pharmaceutical Affairs Law (PAL) that was passed in 2002 will be the re-categorization of medical devices. The Japanese medical devices classification system will be revised in the PAL to take into account the risks... Read More
Japan’s recent food-related scares have prompted the Japanese government to take more serious measures in addressing the country’s food safety. Last year, Snow Brand Food Products Co., was involved in highly publicized scandals involving the distribution of foreign meats labeled as domestic... Read More
A third-party certification system for low-risk medical equipment will be introduced through Japan’s Pharmaceutical Affairs Law (PAL) revisions within the next two years. Products designated by the Ministry of Health, Labor and Welfare (MHLW) as medical equipment requiring controls, or Designated Medical... Read More
Heart disease continues to be one of the leading causes of death in Asia. As countries like Japan, China, Taiwan and the Philippines have a greater demand for medical devices and pharmaceuticals to help treat cardiovascular disease, many foreign medical companies have... Read More
The Pharmaceutical Affairs Law (PAL) that passed legislation in Japan last year included four major revisions that are noteworthy to foreign medical device manufacturers: Revision of the measures for safety related to medical devices, Enhancement of the measures for safety after marketing,... Read More
Once a company registers its medical device product in Japan, there is often a question of whether to register its new or upgraded products as partial amendments to its existing Shonin or under a new me-too product application. According to the Ministry... Read More
In order to create a more integrated system for Japan’s medical regulatory process, the Ministry of Health, Labor and Welfare signed a bill at the end of 2002 establishing a new independent administrative institution. The new institution will unify the Organization for... Read More
As Asian countries begin to adopt more western lifestyles and foods, “western” diseases are becoming more prevalent killers in Asia. Economic transition, urbanization, and technological development have brought about lifestyle changes that have increased the chances for heart disease in Asia. Developing... Read More
This article covers some of the changing dynamics of the regulatory scene in Asia for pharmaceuticals and medical devices, with information and updates from China, Korea, Japan and Taiwan. Drug prices and reimbursement rates have been cut as governments take steps to... Read More