The size of the medical device market in Japan is $25.5 billion. This is two and a half times larger than China, making it the biggest medical device market in Asia. But fierce competition, strong demand for high quality products and complex regulations make Japan the most difficult Asian market to enter for foreign medical device companies.
When a foreign device company seeks to enter Japan, there are several key issues that need to be addressed. First, has your company done extensive market research and is there a demand for your product? Do you have Japanese KOLs that will support your product/technology?
It is surprising how many foreign medical device companies forget these basic questions before they enter Japan. For example, if there is only a limited market opportunity, why register your product in Japan? Just because a device does well in the West does not mean that it will do well in the Japanese market.
In addition, medical device products will usually not sell in Japan if they are not reimbursed. Higher levels of reimbursement will be granted only if the product has significant advantages over competing products.
If your market research on Japan turns out to be positive, you identify several Japanese KOLs to support your device, you have checked potential reimbursement and determined that the pricing will work, the next step is product registration. How much will it cost and how long will it take to get your product approved in Japan?
To determine this, Japan’s PMDA consultation sessions can be especially useful.
PRE-CONSULTATION SESSION
Many Western device companies will first determine their regulatory strategy by having a pre-consultation session with the PMDA. The purpose of the pre-consultation session is to discuss how your product aligns with important Japanese regulations, including the Japanese Pharmaceutical Affairs Law (PAL). Other topics discussed during the pre-consultation session include what type of “official consultation” you should attend next and what documents will be needed for this official consultation session.
Please keep in mind that during the pre-consultation session the PMDA will NOT answer your specific questions. These pre-consultation meetings are free and last about 30 minutes. Applicants do not need to prepare basic information for the PMDA pre-consultation session.
OTHER OFFICIAL CONSULTATION SESSIONS
In addition to the pre-consultation session, the PMDA also offers the following official consultation sessions:
- Pre-application consultation
- Application procedures consultation
- Exploratory clinical trial consultation
- Clinical evaluation consultation
- Clinical trial consultation
- Pre-development consultation
- Safety consultation for biological devices
- Safety consultation for non-biological devices
- Quality consultation for biological devices
- Quality consultation for non-biological devices
- Performance testing consultation
- Additional consultations
Japanese government fees for each PMDA consultation range from $9,000 to $28,000. Only the pre-development consultation session and consultation for application procedures costs less, at about $1,450.
CLINICAL TRIAL CONSULTATION SESSION
The most widely used type of consultation session is the one for clinical trials. This “Clinical Trial Session” covers many topics, including current treatment methods for your target disease, advantages of your investigational device, the device’s indicated use in foreign countries and its course of development. At this meeting, you will need to provide a full data package including clinical data, performance testing data and safety testing data. The PMDA will discuss this data and also the latest version of your Investigator’s Brochure (IB). Finally, the PMDA will also require your protocol plan, a draft of your informed consent form, a list of safety tests, a record of all previous PMDA consultations and all published articles on the product.
The consultation session for clinical trials lasts about two hours and the government fees are about $28,000. Most information should be presented in Japanese.
CONCLUSION
Although costly, these PMDA consultation sessions can be valuable investments for foreign medical device companies who have decided to enter the medical device market in Japan and have new products or new features. The feedback from such meetings is reliable and will serve as an excellent guide to your medical device registration in Japan.