Provisional Translation
| OTO No. | 198 | Classification | MHW-125 |
|---|---|---|---|
| Date of Acceptance | April 17, 1985 | Ministry/Agency Receiving Complaint | Ministry of International Trade and Industry (JETRO) |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Australian firm | Exporting Countries | Australia |
| Subject | Concerning the import of heart pacemakers, exemption from the obligation to make clinical trials again when the size, battery, etc. are changed. | ||
| Details of Measures | Reply was made that the minimum necessary clinical trials data had to be submitted, because when the size and battery, etc. of the built in type pacemaker were changed, it might cause serious influences over its safety and efficacy due to its suitability to human bodies, etc. | ||
| Classification of Processing | D | Directions | II-a |
| Remarks | |||