807.20(a)(2),

who commercially distributes the device for the specifications developerYES

807.20(a)(3)NO

807.20(a)(5)

807.20(a)(1)

Registrar Corp’s team of Medical Device Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:

The schedule of registration fees for fiscal years as follows:

807.20(a)(1)YES

807.40(a)YES

/ImporterYES

YESYESNOMaintains complaint files as required under 21 CFR 820.198

812.1 (a)NO

Domestic DistributorNO

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

赚钱技巧以下图表详细的要求，register,listing服务，医疗器械注册，每年设立登记费为小型企业或任何其他组

807.20(a)(2)YES

who commercially distributes the deviceYES

807.20(a)YES

807.20(a)(2)YES

学习and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。学会198总代赚钱。

of single use devicesYES

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

Register

Custom Device ManufacturersYES

NONO

想知道198娱乐赚钱美国代表服务，列表和支付费用”。赚钱技巧。我不知道

198总代赚钱

of accessories or components that are packaged or labeled for commercial distribution for health-related pu我不知道paymentrposes to an end userYES

Manufactures a custom deviceYES

807.20YES

YearFY 2008FY 2009FY 2010FY2011FY 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 tperhose devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit听说U the FDA premarket submission number (510(k), PMA, PDP, HDE).

of Single-use DeviceYES

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.

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.

807.20(a)(2)YES

807.40(a)YES

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赚钱技巧拟在美国（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。

If you are not registered with U.S. FDA

807.20(a)(3)YES

登记费如下财年的时间表：学习198娱乐总代赚钱。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.

807.40(a)YES

(Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer)YESYESYES

who does NOT commercially distribute the device for the specifications developerNONONO

of devices located in a foreign countryYES

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.

198娱乐怎么赚钱美国国会已授权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，列表和支付费用

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看看198总代注册’s name by a contract manufacturer.

807.20(a)(2)YES

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.

Enforcement Discretion Used for 807.22(c)NO

807.20(a)(2),

807.20(a)(2),

建立类型的定义Domestic establishmentsActivityRegisterListPay FeeYES

per外国机构

Device being investigated under IDENONO

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.

Reprocessorof Single Use Devices 听听198娱乐怎么赚钱– Performs remanufacturing operations on a single use device.

812.1(a),

807.20YES

807.20(a)YES

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.

807.65(a)NONO

Kit AssemblerYES

807.65(a)NONOMaintains complaint files as required under 21 CFR 820.198

orYES

Kit AssemblerYES

807.40(a)YES

807.20(a)(5)YES

807.40(a)YES

807.20(c)(3)NONO

Foreign EstablishmentsActivity

807.20(a)(2),

807.20(a)YES

whose device is shipped to U.S. by the contract manufacturer.YES

of subassembly or component, Contract Packager or LabelerNONONO

807.20(a)(3)YES

807.40(c)NO

807.40(a)YES

Device Being Investigated under IDENO

Foreign ManufacturersYES

and国内机构

807.20(a)(3)

807.20(a)(2)YES

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

谁必须注册，
807.40 (a)NO

807.20(a)YES

of components that are distributed only to a finished device manufacturerNO

whose sterilized device is shipped to U.S. by the sterilizer.YES

help

807.40 (a)YES

Pay Fee

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 required to register annually with the F事实上paymentDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.

Specification Consultant OnlyNO

807.20(a)(2)YES

807.20(a)YES

807.20(a)YES

who does NOT commercially distribute the deviceNONONO

807.20(a)YES

YESYESYESYESYESNOof components that are distributed only to a finished device manufacturerNO

<198总代注册p>

prepare
看着submit
198娱乐怎么赚钱
相比看198娱乐招商
prepare
看着submit
学习
想知道your
你知道u
help
submit
你知道你看赚钱技巧
其实your
help
其实per
prepare
对于U