Japan is a lucrative market with more than 127 million consumers. Its medical device market is third in size behind the US and European markets. While obtaining regulatory approval and qualifying your medical device for reimbursement in Japan is a long process, we can help you every step of the way.
Generally known as “Kokuminkaihoken”, universal health insurance coverage is offered in Japan and an important consideration for medical device manufacturers. Products are categorized for reimbursement as follows:
- A1 (inclusive)
- A2 (designated inclusive)
- B (individual evaluation)
- C1 (new function)
- C2 (new function or new technology)
- F (Is not suitable for insurance coverage)
To obtain reimbursement coverage, the Insurance Coverage Request must be submitted after receiving Pre-market Approval or Pre-market Certification for your medical device.
We can assist you in determining:
- Whether your product qualifies for medical device reimbursement in Japan.
- The proper reimbursement class for your medical device.
- Strategies for obtaining the highest level of Japanese medical device reimbursement.
- Steps needed to navigate the medical device reimbursement process in Japan.
- Filing of necessary paperwork with the appropriate regulatory agencies.
If addition, Emergo will help you obtain regulatory approval to sell your medical device, act as your Designated Marketing Authorization Holder (D-MAH) and also find new medical distributors for you.
Please contact us for more information on medical device reimbursement consulting in Japan.