Provisional Translation
| OTO No. | 503 | Classification | MHW-223 |
|---|---|---|---|
| Date of Acceptance | August 20, 1993 | 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 | Germany |
| Subject | Simplification and international harmonization of application procedures relating to imports of stethoscopes | ||
| Details of Measures | Importers/sellers of medical equipment are responsible for the quality, usefulness and safety of the products they import, and the requirement for such products to undergo performance testing cannot be abolished. This requirement applies to manufacturers as well. Given the nature of their public duties, the administrative authorities cannot suggest individual makers of performance testing facilities or specifications, as determining these should be the responsibility of the importer submitting an application for an import permit. The complainant was advised that the exemption of products from testing as a result of the exchange of government memoranda on the mutual acceptance of GMP inspection results has no direct connection with the performance testing required when importers apply for approval. |
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| Classification of Processing | D | Directions | I-a I-b II-a II-b III IV |
| Remarks | |||