The importation of medical devices that have not yet been approved by the Japanese government falls into two broad categories, based on the purpose of the importation. The first category is for products being imported for personal use by individuals, while the second category covers almost all other products. This second category is divided into two further groups, differentiated according to the nature of the importation. The first group in this category is entities importing the devices for non-clinical evaluation and testing purposes. The second group is entities importing the devices for clinical evaluation and clinical testing purposes. This second group is then further divided into two sections according to the nature of the entity. Basically, it is divided between 1) physicians importing the devices for personal use or for clinical or non-clinical testing purposes, and 2) entities importing the devices for use in clinical trials to be conducted in Japan.
While the above breakdown may appear complicated, it can be simplified by categorizing into three groups as follows:
- Individuals: for personal use only;
- Commercial/non-commercial entities: for non-clinical testing, for clinical testing; and
- Physicians: for personal use, for clinical testing, and for non-clinical testing.
In order to import medical devices for use in pre-clinical feasibility studies, the following documents need to be submitted to the regional health regulatory authorities in Japanese:
- YUNYU HOKOKU SHO (Importation Notification Document) – 2 copies
- NENSHO (Statement of Compliance) – 1 copy
- SHIKEN KENKYU KEIKAKU SHO (Testing and Research Plan) – 1 copy
- SHIIRE SHO (Invoice) – 1 copy
- Air Way Bill (AWB) if by air freight or Bill of Laden (B/L) if by ocean freight – 1 copy
- SHOHIN SETSUMEI SHO (Product Explanation) – 1 copy