| TOP |
| 7th Report of Market Access Ombudsman Council (March 18, 2002) |
1. Complainant: Tokyo Chamber of Commerce and Industry
2. Ministry concerned: Ministry of Health, Labour and Welfare: Ministry of Finance
3. Complaint:
In order to import medical instruments, each sales office of the importer is required to obtain an importer/seller permit beforehand and an import approval and an import item permit for each medical instrument to be imported. Moreover, the importer is also required to submit or present many documents at the customs office.
1] Purchase statement (copy)
2] Air waybill (AWB) or Bill of Landing (B/L) (copy)
3] Medical instrument importer/seller permit (copy)
4] Medical instrument import approval (copy) and import item permit (copy)
5] Submission of the list of customs-cleared parts, etc. (Original documents from the importer)
A list of import/sale permitted items is attached to the medical instrument importer/seller permit. Since the approval number of the medical instrument import approval, the permit date and items (names) are stated in the list, it is possible to certify import/sale permit and import approved items by the medical instrument importer/seller permit. (However, since details of the attachments and parts are stated in the import approval, the customs office demands that the importer specify in what part of the import approval the attachments and parts listed in the purchase statement are individually described.)
Moreover, as to 5] the list of customs cleared parts, a customs broker is required to prepare a parts list in handwriting and describe on what page of the pharmaceutical regulation book each part in the list is described. These requirements delay the issuance of a customs clearance permit and make operations inefficient and complicated.
Therefore, we want the ministry to limit the documents required for submission in importing medical instruments to only the medical instrument importer/seller permit and the accompanying list of import/sale permitted items and discontinue demanding the submission of a written import approval. In this way, the ministry should promote speedy, simplified customs clearance procedures.
4. Corresponding Policy of the Ministries concerned:
Ministry of Health, Labour and Welfare
Customs clearance procedures for medical instruments are carried out at the customs office. Since it is difficult to confirm that imported items and the items the importer is permitted to import and sell (permitted items) are identical from the names of the items alone, it is necessary to confirm the shape, structure, and measurements of the items as well.
Since large medical instruments are sometimes imported in the form of detached parts, it is necessary to confirm that the imported instruments are identical with the permitted instruments from the medical instrument import approval, in which specifications of the medical instrument are described.
Therefore, in order to confirm that the imported items and the permitted items are identical, it is not enough to present a medical instrument importer/seller permit in which only names of the items are given.
Ministry of Finance
(1) As to the submission or presentation of "medical instrument import approval," "import item permit," and "list of customs cleared parts, etc." to the customs office, it is the matter that the Ministry of Health, Labour and Welfare, which is in charge of the Pharmaceutical Affairs Law, has specifically asked the Customs to handle in view of the purpose and necessity of the documents.
(2) The customs office confirms that an importer has the permits and approvals required by other laws and ordinances on the basis of the documents. Article 70 of the Customs Law prescribes that unless the importer certifies in import declaration that he has the permits and approvals in question, the customs office shall not permit import.
(3) Therefore, whether or not omit the submission or presentation of the documents in question is a matter to be decided by the Ministry of Health, Labour and Welfare, which is in charge of the Pharmaceutical Affairs Law.
(Reference)
Article 70 of the Customs Law:
With regard to freight that requires permits and approvals under other laws and ordinances, the importer has to certify in the import declaration that he has the permits and approvals in question. Unless otherwise, the customs office shall not permit the import of the freight.
Basic Notices Related to Customs 70-3-1, Attachment No. 1 (i)-(2)-b:
It is necessary to submit or present "importer/seller license," "import approval," and "import item change (addition) permit."
Communication (Communication issued by Import Division Director on June 10, 1987):
If the importer of a medical instrument or attachments to medical instruments is unable to easily explain to which import approvals the instrument or attachments in question are related, the importer will be required to submit a "customs clearance list of the parts of the medical instrument."
5. Remarks
The complainant accepted this policy.