Provisional Translation
| OTO No. | 269 | Classification | MHW-147 |
|---|---|---|---|
| Date of Acceptance | May 22, 1987 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | USA |
| Subject | On the import of medical equipment, 1. Permission as outside of the regulations for medical equipment, for the import of pressure transducers and transfusion sets that have been removed from their sterile packing. 2. Expansion of products, including this one, as importable on the customs authorities' go-ahead, though the Ministry of Health and Welfare entrusting such inspections to the customs authorities and that this product be added to the list of products importable on the customs authorities' go-ahead. |
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| Details of Measures | 1. It was explained that even if pressure transducers and transfusion sets have been removed from their sterile packing, they could still be resterilized and reused, such that they have not lost their intrinsic capability or classification as medical equipment. 2. Custom clearance for approved medical equipment is within the customs authorities' jurisdiction. At the same time, the customs authorities are also authorized to admit parts for such approved medical equipment. However, given that this product is the main body of a piece of unlicensed, unapproved medical equipment, reply was made that it is imperative that the Ministry of Health and Welfare, charged as it is with protecting the health and lives of the people from such harm as might arise from the use or circulation in Japan of defective or otherwise harmful products, determine the purpose of import, decide whether or not import is really necessary, and affirm that the unit will not be sold or transferred to a third party. |
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| Classification of Processing | 1. D 2. D |
Directions | 1. II-a 2. II-a |
| Remarks | |||