Over the past ten years, more and more Western medical device companies have entered the lucrative Japanese medical device markets. One of the best ways for Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located in Japan; however, this process can be quite challenging.
Pacific Bridge Medical’s expert consultants are highly experienced with locating and qualifying capable and reliable medical device distributors in Japan.
Common Issues Related to Medical Distributor Search in Japan
- Timeframe: Finding the right medical device distributor in Japan can take quite a long time. Japanese distributors often prefer having many face-to-face meetings when initially building up the relationship with your firm. They also tend to be meticulous in regards to understanding your company background and the details of your medical device (e.g. quality systems, current customer base, competitive advantage, etc.), prior to signing a distribution agreement.
- Designated Marketing Authorization Holder (DMAH or MAH): All foreign companies selling medical devices in Japan are required to appoint a MAH. A MAH is responsible for importing products from a manufacturer, ensuring the safety and quality of these products, possibly storing the products in a MAH-licensed establishment and then selling the products to distributors in Japan. The MAH may be either (1) a distributor, (2) a third party entity such as Pacific Bridge Medical, or (3) the company may designate themselves as their MAH if they have an office in Japan. Some foreign companies choose to designate their distributor as their MAH in Japan. However, there are disadvantages to using a distributor. First, the foreign company’s confidential information is put at risk, since the distributor must have access to pertinent information, such as details on product development and raw materials. Second, it can be very difficult for a foreign company to change distributors if their current distributor is not performing well. The distributor may be reluctant to hand over the license, especially if the distributor will lose profitable business. The best way to control your distribution in Japan is to have the registration in your name. Pacific Bridge Medical can serve as your third party entity or DMAH in Japan.
- Expertise: Understanding the supply chain in Japan is difficult. Not all medical distributors will necessarily have a strong background specific to your medical device category. When choosing a Japanese medical device distributor, selecting a company that has specific sales expertise in your device product area is critical.
- Network: Another important issue is to choose a Japanese medical device distributor with excellent connections to key opinion leaders and key purchasers, such as surgeons and hospitals that specialize in your medical device product area.
- Market Presence: Besides providing in-house product registration assistance, a large Japanese distributor with strong market presence can assist with a variety of services to help sell your product.
- Language Barriers: While their reading skills may be proficient, some Japanese medical device distributors may speak only limited English. Therefore, it is imperative for a foreign medical device company to hire medical translators as required.
PBM’s Process for Identifying Qualified Medical Device Distributors in Japan
- First, we begin our groundwork at our local office in Tokyo. Here, we are able to use our local knowledge to research, evaluate, and pinpoint distributors that may be a fit for your company.
- Second, we inform these potential Japanese distributors about your medical device. We will then review the innovative aspects of the product, possibilities for increased indications, and potential threats from new and current competitors with them.
- Third, sales proposals are submitted by the distributors. These proposals highlight their marketing approach to the medical device and projected sales, etc.
- Finally, upon thoroughly analyzing the proposals, we choose distributors that stand out most in terms of relevance to your company and product. We will assist with negotiating the terms of the contract and finalizing the arrangement. Our Japan office can also manage your distributors locally to ensure that they are performing to the highest standards.
Pacific Bridge Medical has 30 years of experience with finding and managing highly qualified Japanese medical distributors. For more information on finding the right distributor in Japan, please contact us to discuss your specific needs.
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