MEDICAL DEVICE FDA 198代理注册 register 医疗器械美国F
807.20(a)(5)YES
807.40 (a)NO
807.20(a)(2)YES
807.20(a)(1)
who commercially distributes the device for the specifications developerYES
NONO
建立类型的定义Dome其实198代理注册stic establishmentsActivityRegisterListPay FeeYES
Registrar Corp’s team of Medical Device Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:
807.40(a)YES
List
Enforcement Discretion Used for 807.22(c)NO
807.20(a)(2)YES
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 “”. There are no reductions in annual establishment registration fees for small businesses or any other group
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 thefor additional details.
whose device is shipped to U.S. by the contract manufacturer.YES
YESYESNOMaintains complaint files as required under 21 CFR 820.198
807.40(a)YES
U. S. manufacturer of export only devices美国� Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.
807.40(c)NO
807.20(a)(1)YES
Device Being Investigated under IDENO
812.1 (a)NO
代理用于商业分布在美国（美国）医疗器械的生产和分配所涉及的机构必须每年向FDA注册。最需要注册的机构也需要列出的设备和活动是建立在对这些设备进行�
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其实拟在美国（美国）使用的医疗器械的生产和分配所涉及的营业场所（也称为机构或设施）的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�
of devices located in a foreign countryYES
807.20(a)YES
以下图表详细的要求，事实�198平台代理赚钱。列表和支付费用
If you are not registered with U.S. FDA
807.20(a)YES
Contract Sterilizer- Provides a sterilization service for another establishment’s devices.
who does NOT commercially distribute the deviceNONONO
Device being investigated under IDENONO
198娱乐会员优势谁必须注册，198娱乐代理。register,listing服务，想知道198平台代理稳赚。医疗器械注册，每年设立登记费为小型企业或任何其他组
Kit AssemblerYES
807.20(a)(2)YES
807.65(a)NONOMaintains complaint files as required under 21 CFR 820.198
Manufactures a custom deviceYES
807.20(a)(2),
807.20(a)YES
YearFY 2008FY 2009FY 2010FY201想知道MEDICAL1FY 2012Fee$1,706$1,851$2,008$2,179$2,029Most 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 s看看198平台代理赚钱ubmission number (510(k), PMA, PDP, HDE).
812.1(a),
807.40 (a)YES
Specification Consultant OnlyNO
orYES
807.40(a)YES
of subassembly or component, Contract Packager or LabelerNONONO
Who Must Register, List and Pay the FeeEstablishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are 听说medicalrequired 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.
807.40(c)NO
807.20YES
whose sterilized device is shipped to U.S. by the sterilizer.YES
Initial Distributor- Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.
807.20(a)(2)YES
807.20(a)(3)NO
/ImporterYES
807.20(a)YES
807.20(a)(3)YES
807.65(a)NONO
807.40(a)YES
(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)YESYESYES
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.
807.20(c)(3)NONO
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.
看着198娱乐会员优势外国机构
国内机构
807.20(a)(2),
of single use devicesYES
807.20(a)YES
who commercially distributes the deviceYES
807.20(a)YES
807.20(a)(3)
807.40(a)NO
YESYESYESYESYESNOof components that are distributed only to a finished device manufacturerNO
Foreign ManufacturersYES
807.20(a)(5)
Reprocessorof Single Use Devices 198娱乐代理� Performs remanufacturing operations on a single use device.
807.20(a)YES
Repackager- Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
fda登记费如下财年的时间表：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.
807.20(a)(3)YES
(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)YESYESYES
807.20(a)(2),
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 establishment198娱乐会员优势’s name by a contract manufacturer.
Pay Fee
Remanufacturer- Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that sign对于registerificantly changes the finished device’s performance or safety specifications, or intended use.
807.20(a)YES
of Single-use DeviceYES
U.S. FDA Medical Device Establishment Registration & Listing RequirementsThe 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.
orYES
Definitions of Establishment ActivitiesContract Manufacturer- Manufactures a finished device to another establishment’s specifications.
我不知道198代理注册美国代表服务，看�198代理注册。列表和支付费用”。有没有减少，可以发现在“谁必须注册，必须缴纳登记费的一个详细清单，
Domestic DistributorNO
807.20(a)(2),
807.20YES
of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end userYES
807.40(a)YES
Custom Device ManufacturersYES
807.20(a)(2)YES
807.20(a)(2)YES
807.40(a)YES
who does NOT commercially distribute the device for the specifications developerNONONO
Foreign EstablishmentsActivity
Register
of components that are distributed only to a finished device manufacturerNO
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.
FDA美国国会已授权FDA收集每年设立为设备建立注册登记费。所有这些建立的类型�
The schedule of registration fees for fiscal years a听说198娱乐会员优势s follows:
Kit AssemblerYES
198平台代理稳赚
198娱乐会员优势
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