While China is getting the most publicity as a place of opportunity for medical device companies, beware: China has its own huge, highly competitive domestic medical device business, a complicated regulatory environment, and a government that is facilitating fast-track approval for locally-manufactured, innovative devices.
While the Chinese medical device market will surpass the size of the Japanese medical device market within five years, Japan is still currently the second-largest medical device market in the world, behind only the United States. Product registration in Japan, which was previously very arduous, is getting somewhat easier. Japan is now allowing the registration of more Class II and Class III products via an independent third-party (notified body), as opposed to the Japanese government or PMDA. In Japan, at least the rules and regulations to register your product are fairly clear, albeit very demanding. In addition, while reimbursement for medical devices has been dropping in Japan over the last 10 years, the country still offers the highest medical device reimbursement in Asia by far.
Medical device companies with high-tech products can oftentimes find a home in Japan’s sophisticated healthcare markets. Japanese medical device companies are still slow to make innovative products. If such high-tech foreign medical devices also have a patent in Japan, the likelihood that the technology will be copied is much lower.
The key requirement to success in Japan is to ensure that all activities are conducted in a meticulous and quality manner. If you submit documents with typos, ship products that contain even a small bug in the corner of the box, or do not follow the registration rules, you will not be successful in Japan.
Developing strong relationship with Japanese key opinion leaders is also important. Doctors in Japan are seen as god-like, and patients almost never question their doctor’s advice. Medical device manufacturers that are looking to develop strong relationships with these key opinion leaders should first determine who is the right expert for their specific product. Then they need to explain their technology to the key opinion leader from a medical and scientific point of view. Japanese doctors can import non-registered products for their own personal use, so it is a good idea to allow them to use and test your product to see if they like it. It is very important that medical device companies stay in close contact with key opinion leaders throughout this process; do let a significant amount of time pass between communications.
Medical device companies can take several steps to ensure their success in the Japanese medical market. Following all of the regulatory requirements with strong attention to detail is a good first step. Developing strong relationships with key opinion leaders who can vouch for your product is equally important. After gaining the support of key opinion leaders in Japan, companies should conduct market research and investigate what reimbursement options are available. While the requirements to enter the Japanese market are high, this sophisticated market offers big opportunities to companies that put forth the effort to develop successful business and regulatory strategies.