Japan Medical Device Registration Being Expedited

Japan’s medical device market is the third largest medical device market in the world, after the US and China. While it is a highly competitive market, unique products with good value propositions can be very successful there.

While in the past Japan medical device registration may have been considered more difficult than China, that situation has reversed itself over the last few years. Japan’s medical device registration requirements are demanding but transparent. In China today, clarity regarding requirements for transparency is still lacking at times. With respect to service and government fees to register devices in Japan and China, the overall cost for registering a device in Japan today is generally cheaper than China. In addition, Japan registration can generally be quicker than in China – where innovative device approvals spanning 3 or more years has become more prevalent.

One example of Japan’s commitment to streamline device registration is the PMDA’s efforts to register more Software as a Medical Device products (SaMD). Currently, Japan is way behind the West in registering SaMD products. In an effort to streamline device registrations, last year the PMDA set up a working group to focus on SaMD approvals.  A 2-step registration procedure is being suggested including an initial approval if the SaMD product can prove efficacy – a conditional approval. Second, if the SaMD product can show its value via actual use and a post-market study, it will receive a second approval. To facilitate the increase in SaMD approvals, the PMDA is increasing its current review staff for these types of products, making more consultation sessions accessible to applicants, providing review feedback earlier, etc. Finally, in early 2024, the PMDA said that SaMD products will receive a priority review and such review will be completed in 6 months. Good news for foreign SaMD makers!

Besides accelerating SaMD approval in Japan, the Japanese government has enhanced its cybersecurity rules. Medical devices coupled with the IT systems of hospitals and other IT devices will be monitored more carefully to alleviate potential problems. Risk management is becoming more important in the life cycle of devices.

In addition, for the first time, the PMDA will set up offices overseas to help innovative device companies better understand the Japan device registration process. Hopefully as more Western innovative device companies learn more about the Japan device registration system as well as other important dynamics, the Japanese people will have better access to new devices from overseas.