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
The advent of genome-based medicine and pharmacogenomics (the medical field that analyzes the reasons why people have different reactions to similar treatment) is expected to transform the medical regulatory environment in Japan. As the human genome is decoded, development of new medicines... Read More
The Japanese Ministry of Health, Labor and Welfare (MHLW) recently announced the establishment of a new Good Laboratory Practice (GLP) regulation for medical device testing in Japan. The new GLP will take effect on October 1, 2003 and will regulate pre-clinical trial... Read More
Before marketing its products in Japan, a medical device manufacturer must first obtain two types of documents from the Ministry of Health, Labor and Welfare (MHLW), the kyoka (license) and the shonin (approval). A kyoka essentially grants a medical device manufacturer or... Read More