Medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products. 2022 Biological Device Application Approvals Key Resources Development & Approval Process (CBER) Biologics Products & Establishments Transfer of Therape...
【解析】Proprietary Device Name仪器名称 Common/Generic Device Name 一般/末注册仪器 名称 Classification Name 类别 Device Class 仪器等级 Product Code 仪器分类代码 Regulation Number 注册编号、名称类别 Medical Specialty: 医学领域 Owner/Operator 制造商 Owner/Operator Number 制造商编号 Registered Establishment Na...
5. Humanitarian Device Exemptions (HDE)人道主义器械豁免 HDE为III类器械提供了一种监管路径,这类器械是预期治疗罕见疾病的患者。可详见Humanitarian Device Exemption (HDE) Program (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-device-exemption-hde-program)。 6. Invest...
4. https://www.fda.gov/Medical-Devices 5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases 6. ../cfrl/rl.cfm 7. ../cfrl/rl.cfm? start_search=1&establishmentName=yiguangnian®Num=&StateName=&CountryName=&RegistrationNumber=301352167...
FDA的器械官费属于一个叫做MDUFA(The Medical Device User Fee and Modernization Act)的法律框架, 这个框架要求每隔5年重新检讨一次,对FDA的发展和收费进行调整。这个MDUFA计划已经进行了4次,2023年到2027年是第五次的检讨和调整,称为MDUFA V。检讨和调整的流程是: ...
Healthcare analytics, AI solutions for biological big data, providing an AI platform for the biotech, life sciences, medical and pharmaceutical industries, as well as for related technological approaches, i.e., curation and text analysis with machine learning and other activities related to AI ...
- 产品注册/产品列名 (MDL: Medical Device Listing) - 指定FDA注册的美国代理人US Agent - 指定FDA注册的官方联系人Official Correspondent - 涉及到FDA510(K)或PMA监管的产品,还需要先申请510(K)或PMA获批后,才可以进行产品注册。 - 如果是从美国境外进口的器械,美国境内进口商还需要单独进行FDA进口商公司注册...
For medical devices,[6] look to well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, reports of significant human experience with a marketed device as sources of scientifically sound...
Initial Importer Service for Medical device. FSVP Plan for Food Industry. FSVP Importer and FSVP Agent for foreign supplier. FDA Cosmetic Registration & Product Listing Useful link: How to searchFDA Registration Number? Willow Glen FDA registration & certification!
服务搜索 SEARCH 请选择分类 FDA医疗器械注册FDA Registration for Medical Devices出口美国的医疗产品需要经过美国联邦药监部门严格的FDA510(K)备案及GMP质量体系认证。 FDA Registration - FDA Medical Devices 医疗器械注册 The U.S. Food and Drug Administration [FDA] requires U.S. and non U.S. companies ...