Japan Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices - Customs Forum

**admin** · 07-23-2011, 17:40 PM

General Market Condition: Restricted
Are there special restrictions or tariffs that apply to used medical equipment?
All imports of used equipment are treated the same as new, and thus each product must obtain MHW (Ministry of Health and Welfare) approval for import.
Although there is no tariffs levied on medical devices, this area is highly regulated by the Pharmaceutical Affairs Law of the Ministry of Health, Labor and Welfare (MHLW). In order to market a foreign medical product in Japan, an importer must obtain “manufacturing approval” ( shonin ) for safety and efficacy of a medical product. In order to handle a shonin-approved product, an importer or a seller needs to obtain “ kyoka ” license based on its facility, personnel and qualification of a technical director. A foreign manufacture may obtain the shonin approval by using an in-country care taker (ICC). If a foreign manufacturer receives a shonin approval, an importer is not required to obtain a shonin approval for such items.
In many cases, a Japanese importer receives “manufacturing approval” ( shonin ). It means that an importer who has a shonin approval will have a full control. If a different importer wishes to sell the same product (either used or new), this importer must receive a product approval from the Ministry. If a US manufacturer holds an approval, they can sell their product through multiple distributors that have “ kyoka ” license to sell medical devices in Japan. A Japanese doctor can import a medical device to treat his/her patients at his/her risk. However, in this case, no reimbursement is given for those treatments, and thus direct import from Japanese general clinics and hospitals is very limited. Japanese beauty clinicians and veterinarians often import new and used medical device as their treatments have no reimbursement coverage in Japan's system.
Can public health institutions buy used or refurbished medical devise?
Although there is no statistical information available, used/refurbished medical equipment is becoming more attractive to medical institutions, including public hospitals, because of cost factors. This trend may continue coming years as the financial status of many Japanese hospitals is also becoming more precarious. Over 70 percent of Japanese hospitals are believed to be operating in deficit and the number of hospitals declaring bankruptcy is increasing. More efficient use of used/refurbished medical equipment may be needed to meet these growing financial challenges.
Is there a market for used or refurbished medical devices?
The sale of such equipment in Japan is a more viable option for local manufacturers and re-sellers than for third-party exporters. Industry sources indicated that market demand for such equipment is particularly strong for ultrasonic diagnostic equipment, X-ray equipment, clinical examination/laboratory equipment, etc.
If there is a market, what types of used or refurbished medical equipment are in the greatest demand?
The Japan Federation of Medical Devices Associations (JFMDA) has prepared a guide on the handling of second-hand medical devices with the objective of establishing a closer network system between manufacturers and medical facilities and to ensure the safer and more effective use of these devices.

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