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 registration and reimbursement in Japan, companies should conduct primary market research, which includes information on the market size and forecasted growth rate. Ideally, market research in Japan should be conducted by local Japanese experts. It is crucial to determine competing products on the market, their classifications, approval statuses, and sales performance. Your market entry strategy should include how your product can compete with the existing devices in terms of clinical advantages and pricing. Insights from Key Opinion Leaders (KOLs) will be helpful for this question.
If your device is not unique and will be reimbursed according to the functional reimbursement categories, you need to evaluate whether the price you receive makes selling in Japan a viable option. If your device is unique, you need to consider whether the Japanese reimbursement system offers a high enough price to make the registration, reimbursement, and associated costs and timeframe worthwhile. If the new expected reimbursement price for your unique device does not cover the price you want to sell it for in Japan, perhaps Japan is not the best opportunity for your product. While Japanese device reimbursement 10 years ago was very generous and often equal to or more than the US, such pricing is no longer available in Japan. Device pricing in Japan today is generally more in line with pricing in Europe, rather than the US or Australia.
A basic list of required documentation for device approval in Japan:
- Application documents
- STED (Summary Technical documents)
- Summary of the product overview, including the history, comparison with similar devices, and the use in other countries
- Conformance to Basic Requirements Criteria
- Information on Equipment
- Summary of Design Verification and Validation Documents
- Risk management documents
- Information on Manufacturing
- Clinical trial test results – if needed
- Post Marketing Surveillance Plan
- Documents related to in vitro and in vivo studies
- Others geared specifically to your device.
Registration in Japan for Class 2 Ninsho products typically takes between 6-9 months, and for Class 3 and Class 4 devices, between 12 and 18 months, excluding the time required for a local clinical study, if necessary. However, please note that Japan is very stringent in its device registration requirements, and providing complete and accurate data is essential.
Typically, device reimbursement is determined about 6 months after product registration. However, for unique devices, reimbursement decisions may take longer to process. In addition, companies with unique medical devices can typically arrange a preliminary meeting with the MHLW to introduce their product, explain its uniqueness, and discuss how it will benefit the Japanese healthcare system, reduce government healthcare expenditures, and assist Japanese patients. While this preliminary MHLW session may be beneficial for addressing a few reimbursement questions, it will not result in a final determination of reimbursement. Thus, for unique devices trying to determine the Japanese reimbursement price needed to make the business successful, such as attending an MHLW meeting or several MHLW meetings, this may not definitively help you determine whether it makes sense to register in Japan.
Key documents that need to be provided before reimbursement is granted are listed below.
- Insurance coverage request form
- Medical device insurance coverage request materials
- Estimated number of applicable patients and basis for forecasted sales
- Rationale for no similar functional classification
- Rationale for applying for the supplemental reimbursement fee
- Medical technology related to your device
- Materials on price adjustment
- Health economic benefits (cost-effectiveness analysis)
- Market authorization document
- Application form for marketing authorization
- Manufacturing and marketing approval review report
- Clinical outcomes showing the reason a high reimbursement price is needed
- Other miscellaneous documents as requested, including cost analysis
In short, the path to success in Japan is complex and involves numerous variables. Just because your device is selling well in the West does not guarantee success in Japan. Careful planning and thorough research are necessary before registering your device in Japan and applying for reimbursement. Conducting extensive research is always the best way to proceed in foreign and complex markets like Japan.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.