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MEDICAL DEVICE FDA register 医疗器械美国FDA注册、认证  

2012-03-20 10:36:54|  分类: 医疗器械认证 |  标签: |举报 |字号 订阅

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美国代表服务,医疗器械注册,register,listing服务,510K注册服务:medicaldevice@qq.com 


U.S. FDA Medical Device Establishment Registration & Listing Requirements

FDA Registration and U.S. Agent Requirement (Bioterrorism Act)The U.S. FDA is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee.


If you are not registered with U.S. FDA

Registrar Corp's team of Medical Device Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:
  • Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with U.S. FDA and make changes, updates and cancellations as needed at no extra cost.
  • Assistance determining if U.S. FDA Medical Device User Fees are required for your registration and, if so, help prepare and submit your payment per U.S. FDA's requirements.
  • Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information.
FDA MEDICAL DEVICE REGISTER AND LISTING
美国(美国)使用医疗器械的生产和分配涉及营业场所(也称为机构或设施业主或经营者必须每年向FDA注册这个过程被称为设立登记

美国国会已授权FDA收集每年设立设备建立注册登记费所有这些建立类型,必须缴纳登记费一个详细清单可以发现必须注册,列表和支付费用没有减少每年设立登记为小型企业或任何其他

登记费如下财年时间表

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations. A detailed list of all those establishment types that have to pay the registration fee can be found at "Who Must Register, List and Pay the Fee". There are no reductions in annual establishment registration fees for small businesses or any other group

The schedule of registration fees for fiscal years as follows:

YearFY 2008FY 2009FY 2010FY2011FY 2012
Fee$1,706$1,851$2,008$2,179$2,029

Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number (510(k), PMA, PDP, HDE).


Who Must Register, List and Pay the Fee

En Espa?ol

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.

The following charts detail the requirements for registration and listing based on the type of activity performed at that establishment. The chart also includes a column showing which types of activities require payment of the establishment registration fee. See the Fee page for additional details.

  • Domestic establishments
  • Foreign establishments
  • Definitions of establishment types
  • 必须注册,列表和支付费用


  • 用于商业分布美国(美国)医疗器械的生产和分配涉及机构必须每年向FDA注册需要注册机构也需要列出的设备活动建立这些设备进行

    以下图表详细的要求,根据活动的类型建立执行登记和上市图表还包括一列显示哪些类型的活动需要支付,设立登记费页面看到更多细节

    国内机构
    外国机构
    建立类型定义

Domestic establishments

ActivityRegisterListPay Fee
ManufacturerYES
807.20(a)
YES
807.20(a)
YES
Manufactures a custom deviceYES
807.20(a)(2)
YES
807.20(a)(2)
YES
Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end userYES
807.20(a)(5)
 
YES
807.20(a)(5)
YES
Manufacturer of components that are distributed only to a finished device manufacturerNO
807.65(a)
NONO
U.S. Manufacturer of export only devicesYES
807.20(a)(2)
YES
807.20(a)(2)
YES
Relabeler or RepackagerYES
807.20(a)(3)
YES
807.20(a)(3) 
NO
Contract manufacturer who commercially distributes the device for the specifications developerYES
807.20(a)(2), 
YES
807.20(a)(2), 
YES
Contract manufacturer who does NOT commercially distribute the device for the specifications developerNONONO
Contract manufacturer of subassembly or component, Contract Packager or LabelerNONONO
Contract sterilizer who commercially distributes the deviceYES
807.20(a)(2),
 
YES
807.20(a)(2),
 
YES
Contract sterilizer who does NOT commercially distribute the deviceNONONO
Kit AssemblerYES
807.20(a)
YES
807.20(a)
YES
Domestic DistributorNO
807.20(c)(3)
NONO
Specification DeveloperYES
807.20(a)(1)
 
YES
807.20(a)(1)
YES
Specification Consultant OnlyNO
 
NONO
Initial Distributor/ImporterYES
807.40(a)
NO 
Enforcement Discretion Used for 807.22(c)
NO
Device being investigated under IDENONO
807.40(c)
NO
Reprocessor of single use devicesYES
807.20
YES 
807.20
YES
RemanufacturerYESYESNO
Maintains complaint files as required under 21 CFR 820.198
(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)
YESYESYES


Foreign Establishments

Activity

Register

List

Pay Fee
Foreign ManufacturersYES
807.40(a)
YES
807.40(a)
YES
Foreign Exporter of devices located in a foreign countryYES 
807.40 (a)
YES
807.40 (a)
NO
Contract Manufacturer whose device is shipped to U.S. by the contract manufacturer.YES
807.40(a)
YES
807.40(a)
YES
Contract Sterilizer whose sterilized device is shipped to U.S. by the sterilizer.YES
807.40(a)
YES
807.40(a)
YES
Reprocessor of Single-use DeviceYES
807.20(a)
YES
807.20(a)
YES
Custom Device ManufacturersYES
807.20(a)(2)
YES
807.20(a)(2)
YES
Relabeler or RepackagerYES
807.20(a)(3)
YES
807.20(a)(3)
NO
Kit AssemblerYES
807.20(a)
YES
807.20(a)
YES
Device Being Investigated under IDENO
812.1 (a)
NO
812.1(a),
807.40(c)
NO
Specification DeveloperYESYESYES
RemanufacturerYESYESNO
Manufacturer of components that are distributed only to a finished device manufacturerNO
807.65(a)
NONO
Maintains complaint files as required under 21 CFR 820.198
(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)
YESYESYES


Definitions of Establishment Activities

Contract Manufacturer - Manufactures a finished device to another establishment's specifications.

Contract Sterilizer - Provides a sterilization service for another establishment's devices.

Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.

Initial Distributor - Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.

Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).

Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

Remanufacturer - Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.

Reprocessor of Single Use Devices – Performs remanufacturing operations on a single use device.

Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

U. S. manufacturer of export only devices – Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.

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