Application for 【Import Confirmation Certificate】 of #Medical Devices in #Japan
📑 1、Documents Required
To effectively prevent unlicensed, unregistered, or inferior products from illegally entering the domestic market in Japan, the Kanto-Shinetsu Regional Bureau of Health and Welfare has stipulated that, for goods undergoing import procedures at Hakodate Customs, Tokyo Customs, and Yokohama Customs, importers must submit specific documents before customs clearance. Only after rigorous inspection by relevant authorities and confirmation that there are no issues will the "Import Confirmation Certificate" be issued.
Given the differences in import purposes, the required documents for the import confirmation application may vary. Taking "import for exhibitions" as an example, the necessary documents are as follows:
1. Two copies of the Import Application Confirmation Form
2. One copy of the product description
3. One copy of the exhibition invitation letter
4. One copy of the exhibition introduction materials
5. One copy of the invoice
6. One copy of the bill of lading (photocopy)
7. One copy of the power of attorney
📑2、Submission Timing
In principle, the import confirmation application can be submitted once the goods arrive in Japan. However, if the goods are still in transit and have not yet arrived, but necessary documents such as the air waybill (AWB) or bill of lading (B/L) are complete, the application can also be submitted. In such cases, the expected arrival date of the goods should be indicated in the "Import Date" column of the Import Confirmation Application Form.
📑3、 Issuance Timeline
In general, if the content of the import confirmation application is correct, the local Bureau of Health and Welfare will issue the import confirmation certificate approximately 3 to 4 working days after receiving the paper application form.
Since February 1, 2023, the "Import Confirmation Information System for Pharmaceuticals, etc." has been officially launched, enabling online applications. For online submissions, the electronic version of the import confirmation certificate will typically be issued within 2 to 3 working days.
The "Import Confirmation Information System for Pharmaceuticals, etc." also provides online handling services for the following three categories of declarations:
· Import for personal use
· Import for treatment by physicians, etc.
· Import for experimental research and other purposes.
