Importing clinical supplies into Japan requires a level of precision not seen anywhere else in the world. At first glance this may seem odd as the Japanese importation process does not include items of technical difficulty, a tedious application process, or a lengthy wait time for an import license. What it does require is a high level of formality and organization that must be followed precisely. Import attempts that do not will be delayed and sent to the back of the line.
Using a depot in Japan is highly recommended to help navigate the importation of clinical supplies. Where most countries require an exporter and an importer of record, Japan has an extra layer to the importation process, the In-Country Caretaker (ICC). The ICC represents the importer to the Japanese government, and is responsible for recovering the package upon arrival, bringing it to the customs warehouse, presenting the appropriate documents and paperwork to customs, and answering any questions the Japanese government may have. Some ICCs may also request a particular order of the documents, so that the documents are presented to the customs inspector in the correct order (according to the ICC).
These requirements therefore require that even before a shipment is even made the ICC needs to be communicating with the exporter of record, such as your clinical trial services provider or packager, to advise and agree exactly what documents need to be included with the shipment. These documents can include but are not limited to: label text, CTAs, data on the comparators, the pedigree of your materials, and your commercial invoice. Only once all documentation is prepared exactly as it has been requested, will you be given the greenlight to make your shipment.