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The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective October 1, 2012. To assist the medical device industry, Registrar Corp has provided the following list of top 10 things that medical device professionals need to know regarding FDASIA:

  1. All proprietary names under which a medical device is marketed must be reported, at a minimum, when a medical device is first listed and during the annual update of registration and listing information.
  2. Combination products (i.e. products comprising a medical device and a biological product or a drug) must be identified as a combination product and the type of combination product.
  3. All contract manufacturers and sterilizers of finished medical devices must register and list regardless of whether they put the medical device into commercial distribution or return the medical device to the manufacturer or specification developer.
  4. Initial importers must identify the manufacturers of the medical devices they are importing.
  5. Foreign establishments that are exporting medical devices or offering medical devices for export to the U.S. must identify all known U.S. importers of their devices.
  6. A device must be listed by the manufacturer, specification developer, single-use medical device reprocessor, remanufacturer, or repacker /relabeler before a foreign exporter, contract manufacturer, or contract sterilizer can list it.
  7. Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to “Complaint File Establishment.”
  8. Establishments located in foreign trade zones must now register and list, as well as identify themselves as being located in a foreign trade zone.
  9. All establishments that are required to register must now pay the annual registration user fee as required by Food and Drug Administration Safety and Innovation Action (FDASIA).
  10. To have your medical device registration, renewal, and listing submitted to FDA by a Regulatory Specialist, simply contact Registrar Corp at +1-757-224-0177.  Registrar Corp’s Regulatory Specialist are available to assist you as the new requirements take effect on October 1, 2012.  For 24/7 Live Help, visit www.registrarcorp.com/livehelp

 新版美国食品药品监督管理局(FDA)安全和创新法案(简称FDASIA)加入了多项强制执行的医疗器械企业注册和产品列明的新要求,将于从2012年10月1日开始生效。为了更好的协助医疗器械企业注册,Registrar Corp 列出以下十项医疗器械行业专业人士最需了解的有关FDASIA的最新要求:

  1. 在医疗器械产品首次列名和注册年度更新时,医疗器械企业至少必须报告该项医疗器械产品的专有名。
  2. 复合型产品必须明确标示为复合型产品以及复合型产品的类型(如医疗器械、生物制品和药品组成的复合型产品)。
  3. 所有合同制造商和灭菌商,必须向美国FDA 提交医疗器械企业注册和产品列名,无论是将医疗器械产品直接上市销售,还是将该产品给回生产厂家或者产品开发商。
  4. 美国境内的医疗器械初始分销商/美国进口商在向美国FDA 提交医疗器械注册时必须明确指出其进口产品的生产厂家信息。
  5. 所有出口医疗器械、或者供应出口到美国的医疗器械的非美国企业在向美国FDA提交医疗器械企业注册和产品列名时必须明确指出该器械的所有美国进口商的信息。
  6. 一个医疗器械的生产厂家、开发商、一次性医疗器械产品再加工商、再生产商、或者再包装商/再贴标商必须在医疗器械出口商、合同制造商或灭菌商做产品列名之前进行产品列名。
  7. 只负责处理投诉文件单位如若之前注册为生产商或者产品开发商,必须将其企业性质更改为“投诉处理公司”。
  8. 位于外贸保税区的企业也必须向美国FDA 提交医疗器械企业注册和产品列名,且须指出其所处的外贸保税区。
  9. 根据美国食品药品监督管理局(FDA)安全和创新法案(简称FDASIA),所有注册的医疗器械企业,无论企业的类型或从事的商业活动如何,都必须缴纳美国FDA的官方年费。
  10. 如果您需要有关美国FDA 医疗器械企业注册、年度更新和产品列名的帮助,请联系Registrar Corp, 联系电话:+1-757-224-0177。Registrar Corp的法规专家将在新规则2012年10月1日生效后给予您必要的协助。全天24小时在线协助,请登录:www.registrarcorp.com/livehelp

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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