FDA常用指南文件清单 序号中文文件名称原文文件名称1上市前批准申请模块审核Premarket Approval Application Modular Review2医疗器械的电子副本提交程序eCopy Program for Medical Device Submissions3上市前批准…
FDAImports.com Convinces an Obstinate FDA to Remove Client from Import Alert #72-03 Red List Okay, I am on an Import Alert. Now What? Once FDA has issued an import alert, the importer can seek release of the shipment by proving to FDA that their shipment is actually compliant. Once evi...
A common question is to wonder if an importer can also act as a U.S. Agent. Acting as the U.S. Agent is a responsibility and a risk; the U.S. Agent’s purpose is to facilitate communications with the foreign facility, but the U.S. Agent can be held responsible for some fees. ...
FDA warns Rx importer.Reports on the U.S. Food and Drug Administration's (FDA) issuance of a letter warning Rx Depot Inc. that its Lowell, Arkansas outlet is illegal and a threat to public health. Enforcement move against U.S. storefront operations aiding Canadian mail-order pharmacies; ...
1, the importer or agent will submit the declaration form to theCustoms at the port of entry within five days of arrival of the goods. 2. The food and Drug Administration (FDA) is informed of the entryof regulatory food through the following channels A copy of customs declaration form (CF...
Complete name and address of the importer, purchaser or ultimate consignee and their FDA registration numbers (if available) The "Required Information for FDA Prior Notice Submission" must be included with the shipping documents for DHL to file PN on the customer’s behalf. Note that a separate...
FDA水产品HACCP 法规 - 21 CFR 123, 1240 FDA水产品HACCP 法规 • Subpart A – Definitions 定义 – Good Manufacturing Practices (GMP) – Hazard Analysis & Hazard Analysis Critical Control Point plan (HACCP计划) – Corrective Actions 纠正措施 – Verification 验证 – Records 记录 – Training 培训...
IMPORTER REQUIREMENTS Affirmative Step Requirement - Choose at least one: 任选其一 On-site visits by the importer 进口商现场检查 Obtaining the processor’s HACCP and sanitation records 得到加工者的HACCP计划和卫生方面的记录 Obtaining the processor’s HACCP plan and guarantee 得到加工者的HACCP计划和保证...
1 FDA水产品HACCP法规 SubpartA Definitions定义GoodManufacturingPractices（GMP）HazardAnalysis&HazardAnalysisCritical ControlPointplan（HACCP计划）CorrectiveActions纠正措施Verification验证Records记录Training培训Sanitation卫生（SSOP）RequirementsofImportedProducts对进口产品 的要求 FDA水产品HACCP法规 SubpartB-SmokedFish烟熏鱼...
our development strategies with the regional development initiative of Mongolia. As the largest exporter and importer of Mongolia, China will work with Mongolia to reach the 20 billion goal set by our leaders to bring benefits...