Provisional Translation
| OTO No. | 304 | Classification | MHW-159 |
|---|---|---|---|
| Date of Acceptance | August 7, 1987 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Keidanren (proxy complaint) | Exporting Countries | |
| Subject | Adoption of the system waiving individual approval requirements for medical devices (artificial joints and the like) that uses the same material used, standards, and testing methods and differs only in size. | ||
| Details of Measures | It was explained that the scope of medical devices not requiring manufacturing approval on each item as specified under Article 18 of the Enforcement Regulations for the Pharmaceutical Affairs Law is at present restricted to those 34 items that are used directly by specialists, for which safety can be guaranteed, and for which the technology is established. It was further explained that the requirement for item-specific manufacturing approval couldn't be waived for such medical devices as artificial joints, even if the materials, specifications, and test methodology are identical, because of the major influence on the body such differences as arm length can have. It was added, however, that it is possible to submit batch applications when size is the only difference so long as safety can be guaranteed. |
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| Classification of Processing | Ca | Directions | II-a |
| Remarks | |||