Licenses

In general, there is little English information made available on licenses and permissions in Japan.  In particular, if a company is active in sectors such as construction or the medical sector, licenses will be required. It is advisable to orientate at an early stage what licenses are required. 

The Ministry of Land, Infrastructure, Transport and Tourism gives a general outline regarding the construction license system in Japan.

 Link:  The Construction License System in Japan 

To obtain a construction license, it will mean that a foreign company will have to show that it has relevant in-house engineering capabilities.  In practice, this will mean that a company will have to individually apply with MLIT or a regional organization and have the qualifications of the engineers present in the company verified for equivalency.  The presence of qualified engineers is usually also part of obtaining the supplier qualifications for public works (keishin). The JTPP Helpdesk can assist you with obtaining licenses if necessary.  

 

Medical sector

If the procurement concerns medical or pharmaceutical products, the tender notice will stipulate as one of the preconditions for suppliers that they have registered with the relevant authorities, in accordance with the pharmaceutical affairs law, to initiate a business of selling medical appliances, or that they have obtainted a first-class license for selling drugs in accordance with the pharmaceutical law. Also they need to obtain accrediation as a foreign manufacturer of drugs and medical devices. After obtaining accreditation, companies will also have to obtain import permits for each medical device seperately. 

There is substantial information in English available about the procedures and the Japanese government strives to shorten the time it takes to have products approved. More information on procedures and regulations is available at Pharmaceutical and Medical Devices Agency (PMDA)  and Japan Pharmaceutical Manufacturers Association (JPMA)