Japan continues to rank among the most intriguing markets for the medical device industry. It offers the third-largest medical device market worldwide, along with a very developed healthcare infrastructure and universal healthcare insurance. Nevertheless, success within the Japanese medical device market demands more than receiving regulatory clearance. It is essential to understand medical device reimbursement from the initial planning phase.
It is essential that, before launching the process of product registration, comprehensive market research is carried out. This will help identify existing competitor products, the current prevalence of the device within the category of reimbursed products, the pricing standards, and the clinical data. It is also critical that Japanese Key Opinion Leaders are consulted.
Japan’s medical devices are divided into four categories on the basis of risk. It usually takes 6 months to 18 months to obtain approval, depending on the classification of the product. For dossiers that require Japanese clinical trials, it may take even longer. The application dossier has to include Summary Technical Documents (STED), design/validation, risk management reports, manufacturing, and clinical data.
Japan medical device reimbursement is a separate assessment conducted after regulatory approvals. Devices are either placed into existing functional reimbursement categories or evaluated as new technologies. Products that are not considered novel usually get their pricing on the basis of fee schedules, whereas innovative devices seek new pricing categories along with premium reimbursement. However, the pricing environment in Japan’s healthcare industry is getting more conservative. The current reimbursement status of Japan is comparable to that of Europe, as opposed to that of the U.S. market.
For innovative products, extensive data regarding pricing rationale, cost-effectiveness, estimates of patient population, and clinical outcomes needs to be provided. Interactions with the Ministry of Health, Labour, and Welfare (MHLW) can provide insight, but these do not ensure positive results for reimbursement.
Increasing Reimbursement After Initial Pricing
While adjustments to the initial reimbursement assessment are possible, this will rarely be easy. Manufacturers may apply for a reassessment if new evidence demonstrates greater clinical value or cost-effectiveness. Strategies may include generating updated health economic data, securing strong support from academic societies, and aligning clinical guidelines to better reflect the device’s role in care pathways.
The other approach could be seeking approval for a new indication. If the new indication provides a different clinical use that is well supported, there could be justification for higher compensation on the basis of a new reimbursement submission. Nonetheless, it will entail extra regulatory approvals, including clinical trials.