一类医疗器械注册FDA, 美代加注册费用为3000元人民币， 另外还有美国FDA的官费， 2026财年是 Annual Establishment Registration Fee: $11,423
具体见FDA官网: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
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