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Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation... Read More

Japan is the third-largest medical device market in the world, so it warrants important attention by medtech companies planning their global commercial strategy for new products. But for foreign device firms the country is not an easy one in which to make... Read More

On August 26, the MHLW released its FY2026 budget, which showed an increase of 550 billion yen from the previous year. The total 2026 budget is planned for about 35 trillion yen. There are many goals of the increased budget, including expediting... Read More

Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have... Read More

Over the past year, Japan’s regulatory and reimbursement environment for medical devices has been rapidly changing. These changes illustrate the government’s ongoing commitment to healthcare innovation, effective reimbursement mechanisms, and expanded oversight under the updated Pharmaceutical and Medical Device Act (PMD Act).... Read More

In Japan, recruiting patients for clinical trials is not an easy process. Advertising regulations for investigational trials, under Article 68 of the PMD Act, are restrictive and follow the same rules as advertising regulations for already approved drugs. This has made it... Read More

Historically, Japan has required, in its Good Clinical Practice ordinance, each clinical trial site to have its own IRB, which means each site director needs to ask for an IRB review separately. Unfortunately, this makes doing trials at multiple sites overly complicated.... Read More

Japan is the world’s third-largest medical device market. Thus, many foreign device companies are interested in exporting their devices there. However, being successful in Japan is a complex endeavor, and foreign device companies must consider several key factors before moving forward. Before starting device... Read More

This article was originally published on MedTech Intelligence Over the last few years, we have encountered this problem with a number of clients. Once you have received an initial reimbursement price where your sales price in Japan does not yield a profit,... Read More