2010年乌克兰医疗设备国家登记(上市许可)所需文件
I.行政文件与表格:
II.申请者的正式文件(业主的上市许可):
III.制造商的正式文件:
NB!如果采用好几个制造商,每个制造商必须提供上述所有文件。
IV. 医疗设备文件:
蓝色加亮标出的几点- 应该根据国际郭求合法化(公证人核证或/和札记)。详情请联络我们。
Annex 1 附件1
Information for Application 申请信息
Please fill in the table below/请填下表:
Name of the medical device(s): 医疗器械名称 |
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Custom commodity code: 定制商品代码 |
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Applicant:申请人 |
Name: Address: Telephone, fax: |
Manufacturer(s): 制造商 |
Name: Address: Telephone, fax: |
Safety class according to MDD 93/42/EEC: MDD 93/42/EEC安全等级: |
I / IIa / IIb / III |
Explanations说明:
Name of the medical device(s) – please suggest a group name of the medical devices that you intend to register in Ukraine. For example – “Dental materials Dentamax”, “MRI system Magnetplus®”, “Silicone breast implants Beauty®”, “Metal optical spectacle frames” etc. You can include the trade name, or in case of registration of several brands – you are allowed not providing it. During expertise of the dossier experts of Cratia can suggest another name for device(s).
Custom commodity code – please suggest the customs code that should be used for your devices. For example, dental cements are classified under the code 3006 40 00 00, surgical gloves are classified as 4015 11 00 00, optical lenses - 9001 40 41 00, syringes - 9018 31 10 00, endoscopes - 9018 90 20 00 etc.
Applicant – can be any company (resident or not resident of Ukraine) that will became an owner of registration certificate. Manufacturer can be the Applicant.
Manufacturer(s) – should be provided in strict compliance with future customs documents and labeling information. Name and address of manufacturer in registration certificate should be completely equal to the name that will be given in Proforma Invoices, shipping list etc.
Safety class according to MDD 93/42/EEC – please open Annex 9 of the Directive and find the applicable rule for your device. Otherwise we will suggest the class by ourselves.
医疗设备的名称- 请建议一组您打算在乌克兰注册的医疗设备组的名称。例如 - “牙科材料Dentamax”,“磁共振成像系统Magnetplus ®”,“硅胶隆胸美容®”,“金属光学眼镜框”等,您可以包括商标名称,如果要注册几个品牌- 你可以不提供它。在对Cratia的专家认真过程中,可以提出另一种设备的名称。
定制商品代码 - 请建议你的设备使用的海关编码。例如,牙科水泥应归入3006 40 00 00,手术手套为4015 11 00 00,光学镜头 - 9001 40 41 00,注射器 - 9018 31 10 00,内窥镜 - 9018 90 20 00等分类代码。
申请人 - 可以是任何公司(是或不是乌克兰居民),将成为注册证书的所有人。制造商可以是申请人。
制造商 - 应按提供严格的未来的海关文件和标签信息。注册证书中的制造商名称和地址要和形式发票,箱单一致。
根据MDD的93/42/EEC的安全等级 - 请打开附件指令9和找到适合您的设备的适用规则。否则,我们将提出我们自己的级别。
Annex 2
Information on modifications, spare parts, accessories and disposables
When your devices will be shipped to Ukraine – customs officer will carefully check the names from Proforma Invoice and shipping lists for compliance with registration certificate. In case if any product will not be found in registration certificate or in case if the name will be given with mistakes – the officer can make a decision that that product is not registered. Please pay serious attention to that issue.
All parts, modules, accessories, modifications, spare parts, disposables and other products that will be shipped by separate name in customs documents or will have a separate label – should be listed.
当您的设备将运到乌克兰 - 海关人员会仔细检查形式发票和箱单上的的名称和注册证书是否一致。如果有任何产品在注册证书中找不到,或者该名称错误,工作人可以作出该产品是未经注册的决定。请重视这个问题。
所有部件,模块,配件,修改,备件,耗材和其他产品,如果要以单独的海关名称或者单独的标签装运 - 应列出。
Please carefully fill in the table below or send us that list in MS Excel format:
No. |
Catalogue number: |
Name in English (according to Invoice): |
Suggest the name in Ukrainian language (or will be prepared by Cratia):乌克兰语名称(或者由Cratia准备) |
1 |
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2 |
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