Business licenses application
Business licenses application in Japan
Entities wishing to export the medical devices to Japan and enter the Japanese market are required to have the following licenses and necessary personnel in Japan.
- Marketing Authorization Holder license – three specially qualified personnel are required
*The number may vary depending on the class of device (PAL Article 12 -1). - Manufacturer license (for packaging, labeling and storage) – one qualified personnel is required (PAL Article 13 -1).
- Retail license (or rental service license) – one qualified personnel is required (PAL Article 39).
- Repair license – one qualified personnel is required (PAL Article 40-2).
To become qualified as a Marketing Authorization Holder (MAH) or a Manufacturer for Packaging, Labeling and Storage, those importing devices from overseas are required to obtain a license from the Governor of the prefecture where their office is located. If a MAH wants to sell its products directly to any medical institution, it must also obtain a retail or rental/lease license. For each license, one to three qualified personnel must be assigned to the required technical roles, so a company wishing to obtain all the licenses must employ and assign a minimum of six qualified personnel. Depending on the type of license, it varies whether or not the qualified personnel can serve the three different roles concurrently within the same company. Foreign companies (i.e. medical device manufacturers) wishing to enter the Japanese market and establish a presence in Japan must therefore obtain the relevant licenses, necessitating the employment of qualified personnel to meet the requirements. If a foreign company chooses not to have its office in Japan but to work with a contracted Japanese company, it is necessary to make sure that the Japanese company holds the appropriate license(s) for their business.
It should be noted that the Marketing Authorization Holder and Manufacturer licenses must be obtained before submission of an application for the approval of medical devices. Additionally, the retail and repair licenses must be obtained by the time import and sales start.
Japan MDC provides consultation services to support Business licenses application.
Business licenses and milestone
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