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...
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。工具/原料 器械商用英文名称（附产品说...
FDA注册证明是指由美国食品药品监督管理局(FDA)颁发的针对特定产品或企业的注册批准文件。根据不同的产品类型,FDA注册证明可能有不同的名称和形式。 以下是几种常见的FDA注册证明: 食品注册证书(Food Facility Registration Certificate):针对食品生产、加工、包装或储存企业的注册证书。这是一个由FDA颁发的唯一标识号码,...
Manufacturers (both domestic and foreign) and initial importers of medical devices must register their establishments with the FDA on an annual basis. Every importer of medical device products to the United States must provide to the FDA with the medical device facility registration number for the ...
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. ...
(e.g., the 510k user fee). 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 ...
FDA(美国食品药品监督管理局)颁发的证件通常是与产品或企业相关的许可、注册或批准文件。以下是一些常见的FDA证件: 食品注册证(Food Facility Registration Certificate):该证书是针对从事食品生产、加工、包装或储存的企业或设施的注册证明。根据美国联邦法律,这些企业需要向FDA注册,并获得有效的食品注册证,才能在美国市场...
This is a notice to the establishment whose Facility Registration and Device Listing have been done within the Fiscal Year 2024. Establishment information Name: JIANGSU YISHUN MEDICAL EQUIPMENT CO., LTD. Address: 25 Haiyan Road, Binhai Industrial Zone, Qidong, Nantong, JIANGSU, 226200, CHINA ...
此外，特定食品品牌的备案信息可以通过“Food Facility Registration and Listing System”（FURLS）进行查询...
Medical Device Establishment registration and listing are still required for these devices.MEDICAL DEVICE REPORTS (MDRS)Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to ...