Provisional Translation
| OTO No. | 178 | Classification | MHW-117 |
|---|---|---|---|
| Date of Acceptance | March 15, 1985 | 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 | |
| Subject | Permission of the use or sale of high-priced medical devices imported for the purpose of clinical trials. | ||
| Details of Measures | Reply was made that, if the medical devices imported for the purpose of clinical trials were high in price or much cost was necessary for their removal or recovery, their use or sale would be permitted after confirming that they were used for clinical trials and that they agreed to requirements for approval. | ||
| Classification of Processing | A | Directions | III |
| Remarks | Improvement measures were taken on July 31, 1985. | ||