FDA Guidance “PMA Post Approval Requirements”
Chinese translation: FDA 指南：PMA批准后要求(批准后规定)
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| 08:20 Dec 21, 2014 |
| English to Chinese translations [PRO] Tech/Engineering - Medical (general) | |||||||
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|  Selected response from: jyuan_us United States Local time: 04:08 | ||||||
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| 5 +1 | FDA 指南：PMA批准后要求(批准后规定) |
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| 4 | FDA 指引 “PMA 核准后若干要求” |
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| 4 | FDA 的指导（书） “PMA 核准后之要求” |
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| 4 | 上市前批准后的若干要求 |
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| 3 -1 | 食品药物局就零配件制造许可颁发后的要求指南 |
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Answers
2 hrs confidence: 
| fda guidance “pma post approval requirements” FDA 指引 “PMA 核准后若干要求” Explanation: What are the PMA Post-approval Requirements? …… Post-approval Annual Reports - intervals of 1 year Postmarked Surveillance Studies - on FDA request Adverse Reaction and Device Defect Reporting - within 10 days …… |
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10 hrs confidence:
| fda guidance “pma post approval requirements” FDA 的指导（书） “PMA 核准后之要求” Explanation: From my understanding from the FDA websites, the "FDA Guidance” here refers to "PMA Post-approval Requiremets." ( "PMA Post-approval Requiremets"是"FDA Guidance”的同位语。） |
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17 hrs confidence: peer agreement (net): +1
peer agreement (net): +1| fda guidance “pma post approval requirements” FDA 指南：PMA批准后要求(批准后规定) Explanation: FDA 指南：PMA批准后要求(批准后规定) 其实requirements是指规定，是强制性的要要求，必须遵守的要求。 |
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1 day 14 hrs confidence:
| fda guidance “pma post approval requirements” 上市前批准后的若干要求 Explanation: 一般指医疗器具批准出售后好要做的事。 |
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2 days 9 hrs confidence: peer agreement (net): -1
peer agreement (net): -1| fda guidance “pma post approval requirements” 食品药物局就零配件制造许可颁发后的要求指南 Explanation: pma= parts manufacture approval 含有许可一词， 供参考 |
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