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
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the entry of 11 new drugs into the National Health Insurance (NHI) reimbursement system effective May 21, 2025. The newly listed drugs include BeiGene’s cancer immunotherapy Tevimbra (tislelizumab), Servier’s Tibsovo (ivosidenib) for... Read More
Japan’s 2025 AI Bill highlights a regulatory change that values innovation rather than restriction, specifically in the pharmaceutical industry. In contrast with the EU’s rule-based system, Japan promotes voluntary compliance and collaboration, with flexible guidelines that speed up drug development. While this... Read More
This article was originally posted on MedTech Intellligence Oftentimes, obtaining the right medical device reimbursement in Japan is more important than both the expected need/demand for your product and medical device registration. Of course, all three things are important. But, if the... Read More
On May 14, 2025, the Japanese government amended the Pharmaceutical and Medical Device Act 2025. Prior to this update, the PMD Act only outlined the roles and responsibilities of the MAH’s key responsible people. It did not have any specific penalties or rules... Read More
In December of last year, we published a news brief explaining that Foreign Reference Pricing is becoming less important in Japan for device reimbursement. Today, Japan’s medical device reimbursement normally closely follows the reimbursement in Europe, not the US and Australia, which are... Read More
As mentioned in our newsletter over the last 18 months, Japan is now taking a more aggressive posture to tackle the issue that many drugs in the West are not yet available in Japan. To help speed up the process, the MHLW has... Read More
Introduction In the fast-paced medical device industry, product quality is essential to guaranteeing patient safety and public confidence. Across the world, regulatory bodies have established stringent quality systems to manage and enforce standards throughout the life cycle of a device. In Asia,... Read More