FDA注册(认证)是参与美国使用的医疗器械生产和分销的业务场所(也称为机构或设施)的业主或经营者在产品正式上市销售前向FDA(美国食品药品监督管理局)提交电子登记的过程。医疗器械FDA注册分为:FDA企业注册(Facility Registration)和器械列名(Medical Device Listings)两部分。 器械商用英文名称(附产品说明) 产品代码、标签...
DFUF账号/密码（Device Facility User Fee website）FURLS账号/密码（FDA’s Unified Registration and Listing System）方法/步骤 1 FDA器械分类查询：根据器械性能、用途判断其分类，通过风险分类确认查询器械代码 2 FDA企业行政美金缴纳：创建DFUF账户，申请PINs，支付该年度行政年金，获得PCNs 3 FDA企业信息登记：创...
设备标识号（Device Identifier，DI）： 设备标识号是一个唯一的代码，由两部分组成。第一部分是由FDA分配的生产商标识号（Facility Identifier，FI），用于标识设备的制造者。第二部分是由制造商自行分配的序列号，用于标识具体的医疗器械。组合起来，设备标识号能够唯一标识每一个医疗器械产品。设备注册号（Registration...
Company Name公司名称 Company Address地址 Post Code邮编 Contact person (Full name)联系人(全名) Tel电话 Fax传真 Mail邮箱 Website网站 Company Activity 组织活动 ProductInformation (For food only)产品信息(仅食品) Product Name产品名 Sign by the authorized person of the applicant授权人签字: Stamp of the...
在FDA设备注册和设施清单(Device Registration and Facility Listing)系统中注册您的产品和生产设施。 提交510(k): 使用FDA电子提交门户提交510(k)申请,确保遵循FDA的要求和格式。 等待FDA审查: 等待FDA对您的510(k)申请进行审查。审查时间可能因产品复杂性和FDA工作负荷而有所不同。
在线注册：通过FDA的FURLS（FDA Unified Registration and Listing System）进行。缴纳年费：注册时需缴纳年度设备注册费。维护和更新：保持注册信息的准确和最新。DFE（Device Facility Establishment）设施注册 定义：DFE是指设备制造或加工设施的注册，适用于所有生产、包装、贴标或重新加工医疗设备的设施。要求：每个生产...
Medical Device Facility Registration Renewal Period is Open Register or renew your registration for 2025 today. The FDA requires facilities that are manufacturing, preparing, propagating, compounding, or processing medical devices to annually register the establishment and list the devices. ...
. The annual FDA registration fee must be paid for each facility registered between October 1 and December 31. Your registration will become inactive if renewal fees are not paid on time. If your device requires 510k clearance, you will not be able to complete the listing process until you ...
Notification to FDA of LDTs Manufactured by a Laboratory or Registration and Listing 17 76 4. Medical Device Reporting (MDR) Requirements 19 77 5. Premarket Review Requirements 20 78 6. Quality System Regulation Requirements 28 79 APPENDIX A: LDT Oversight Framework Summary 30 80 APPENDIX B: ...
• Displaying a “Certificate of FDA Facility Registration and Device Listing of Medical Device” issued by “HUMISS INC.” (HUMISS Certificate) under the “Company qualification” heading, “Product” tab on the product’s webpage. The HUMISS Certificate states that “Dongguan City Xinyuan Non...