803MDR1 Part 803 Medical Device Reporting 의료기기 보고 (MDR) (803.1 – 803.58) Chapter 1 Food and Drug Administration, Department of Health and Human Services Title 21 Food and Drugs제1장 보건복지부 산하 식품의약국(FDA) Subchapter H Medical Devices (800 ~ 898)Part 803 Medical Device Reporting 의료기기 보고 (MDR) (803.1 – 803.58)Subpart A 803.1 – 803.19General Provision (일반 규정)Subpart B 803.20 – 803.23Generally Applicable Requirements for Individual Adverse Event Reports(개별 이상 사례 보고서에 일반적으로 적용.. 2025. 12. 9. 이전 1 다음