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白俄罗斯医疗器械注册白俄罗斯医疗产品认证,白俄罗斯医疗器械认证,白俄罗斯医疗认证,BELARUS REGULATION FOR MEDICAL DEVICES
    发布时间: 2018-09-20 08:56    

白俄罗斯医疗器械注册,白俄罗斯医疗认证,白俄罗斯注册证书白俄罗斯共和国卫生部20081218日第216号决议关于临床试验医疗用品和医疗设备的一些问题(卫生部法令05.03.2010 N 24

 

200892日白俄罗斯共和国部长理事会第1269号决议关于批准医疗设备和医疗设备国家注册(重新注册)的规定


白俄罗斯医疗器械注册

BELARUS – REGULATION FOR MEDICAL DEVICES


白俄罗斯医疗器械注册 registration of honey products Belarus

在白俄罗斯医疗器械注册是强制性程序。注册活动包括质量控制,安全和效率。白俄罗斯共和国第2435-XII号“医疗保健法”于2008年6月18日和白俄罗斯共和国部长理事会2008年8月2日第1269号决议“关于批准医疗产品和医疗设备的国家注册(重新注册)”中规定了白俄罗斯作为国家注册医疗器械的规则。技术要点和要求见相关法规。


国家监管体系|监管框架


 

白俄罗斯共和国卫生部20081218日第216号决议关于临床试验医疗用品和医疗设备的一些问题(卫生部法令05.03.2010 N 24

 

200892日白俄罗斯共和国部长理事会第1269号决议关于批准医疗设备和医疗设备国家注册(重新注册)的规定

 

主要流程

 

阶段1.您向我们发送医疗器械MD产品描述的报价申请。认证报价成本取决于风险等级。

 

阶段2. 根据安全等级组成提交注册登记档案文件清单。注册档案文件必须包括所有文件俄语翻译。 然后我们在白俄罗斯卫生服务测试中心提交RD

 

阶段3.在审查申请人提交的文件后,卫生部应对医疗器械和医疗设备的国家注册(重新注册)或拒绝国家注册(重新注册)的决定作出决定。表明拒绝理由的设备和医疗设备。该决定应以卫生部令的形式作出。 1269决议)

 

阶段4.工厂检查主要在两种情况下提供:首次进入市场,以及需要特殊安装和维护条件的医疗设备(MRIX射线)。通常有3位专家(医生和工程师)到工厂现场工作3天。

 

阶段5.卫生测试需要样品。

 

阶段6.技术测试需要样品。

 

阶段7.参与的患者(志愿者)作为临床试验的受试者不需要与患者身体没有直接接触的MD。在这些情况下,可以对样品进行试验,申请人在临床中心提供。

 

8阶段。注册证书有效期为5年。

要求文件
对于白俄罗斯境外生产的医疗产品和医疗设备的国家注册(重新注册)的文件和(或)信息

1.制造商的信笺,以电子形式提供详细信息。
2.准备申请产品档案(在制造商的信笺上,如果有的话)的初步审查申请;
3.我们准备医疗器械国家注册申请(在制造商的信笺上,如果有的话);
4.更换发给白俄罗斯共和国公司的有缺陷产品的保证书(原件在制造商的信笺抬头)。发送编译示例;
5.我们白俄罗斯授权代表委托书-有权代表白俄罗斯共和国登记机关的制造商(申请人)的利益的授权委托书。发送编译示例;

注意:如果采用我们的授权代表需要空白委托书,可以直接从制造商发给我们的代表(俄语或双语版本)。在这种情况下,发送空白原件(2-3份,信头,盖章和签字)就足够了。如果委托书签发给贵公司与权力等代表团的权利,在这种情况下,你必须提供委托书经大使馆公证的复印件(至少2份),大使馆公证从贵公司对我们的业务代表(加上副本2份。)。

5 *证明在制造商所在国家/地区签发的申报医疗产品质量的文件(以规定方式认证的文件的原件或复印件(白俄罗斯共和国大使馆的公证副本+领事证明+翻译)),包括:
-  CE证书(如果有);
-  ISO 9001(如果有);
-  ISO 13485(强制性);
- 生产现场的ISO 13485,如果与制造商的地址不同(强制性);
- 自由销售证书(医疗产品出口证书)(必需);
- 制造商的符合性声明(必需)。

允许以下列形式提交符合性声明:
- 使用制作人的语言原文,未经翻译且未经指定机构认证;
- 双语版本(制造商的语言+俄语),未经指定机构认证;
- 仅限俄语,未经通知机关认证。

6.技术护照,每个注册产品的标记的描述(样本或布局),医疗产品的使用说明(医疗设备),医疗产品的特定型号的保修期信息,包含与申请日期相关的信息,由制造商认证以规定的方式申报的医疗产品(翻译+签名,制造商的盖章);

7.产品(翻译)。
*  - 质量管理体系的合格证书(CE,ISO 9001,13485),产品合格证书,自由销售证书,制造商符合性声明,在其他国家/地区签发的注册证书(如果有);
  可提供有关产品质量的其他信息,以便对处方临床试验的可行性(不适当性)做出决定:
确认在生产国进行临床试验的文件,临床评估的结果(进行研究的地点和人员,患者数量,根据医疗设备手册中指定的所有适应症(医疗器械使用指南)或其他确认临床的文件声称的医疗器械和医疗设备的有效性;
消费者对医疗器械和医疗设备的反馈;
反映国内外市场医疗器械和医疗设备销售量信息的文件(可选);
文件(或其副本,以规定方式认证),反映使用医疗器械和医疗设备时的不良反应信息。
所有提交的文件必须翻译成白俄罗斯语或俄语,并以规定的方式进行认证。

法规:
-  2008年9月2日白俄罗斯共和国部长理事会决议
№1269“批准药品和药品的国家注册(再注册)条例和医疗产品和医疗器械国家注册(再注册)条例”和“医疗器械和医疗产品国家注册登记”
- 白俄罗斯共和国部长理事会决议批准的卫生部及其下属国家组织对法人实体和个体企业家的行政程序清单
N 1430 of 10/31/2007 10/31/2007 N 1430(经白俄罗斯共和国部长理事会决议修正)

白俄罗斯医疗器械注册

BELARUS – REGULATION FOR MEDICAL DEVICES


 

National regulation system | Regulatory framework    

Ministry of health resolution of the Republic of Belarus  No 216 dated December 18, 2008 ON SOME QUESTIONS OF CLINICAL TRIALS MEDICAL SUPPLIES AND MEDICAL EQUIPMENT (in the red. Ministry of Health Decree of 05.03.2010 N 24)

Resolution of the council of ministers of the Republic of Belarus No. 1269 dated September 2, 2008 ON APPROVAL OF REGULATIONS ON STATE REGISTRATION (RE-REGISTRATION) OF MEDICAL DEVICES AND MEDICAL EQUIPME


Stage 1. You send request for quotation to SHANGHAI SEC with MD description. The cost depends on risk class.

Stage 2. List of documents of registration dossier is formed based on safety class. Documents of registration dossier must include an authentic translation of all the documents into Russian. SHANGHAI SEC submits RD in Center for Examinations and Tests in Health Service.

Stage 3.  Upon review of the documents submitted by the applicant, the Ministry of Health shall make the decision on state registration (re-registration) of medical devices and medical equipment or the decision on denial of state registration (re-registration) of medical devices and medical equipment indicating reasons for denial. The decision shall be made in the form of the Order of the Ministry of Health. (1269 resolution)

Stage 4. Factory inspection is provided mostly in two cases: first entry into a market and in case with medical devices which required special condition for installation and maintanance (MRI, X-Ray). Usually 3 experts (physicians and engineers) go to the factory site for 3 days.

Stage 5. Samples are required.

Stage 6. Samples are required.

Stage 7. Participating patients (volunteers) as subjects in a clinical trial is not required for MD  that do not have direct contact with the patients body. In these cases the trials may be performed on a samples, that the applicant is provided in the clinical center.

Stage 8. Registration certificate valid for 5 years.



Registration of medical devices is a mandatory procedure for these products in Belarus. This is a whole range of activities, including quality control, safety and efficiency. The rules for registering medical devices Belarus as a state were enshrined in the Law of the Republic of Belarus No. 2435 – XII “On Health Care” dated June 18, 2008 and in the Resolution of the Council of Ministers of the Republic of Belarus No. 1269 dated August 2, 2008 “On Approval of the State Registration (Re-registration) of Medical Products and Medical Equipment . Technical points and requirements are indicated in the relevant regulations.


Important: In 2016, it was planned to introduce the registration of medical devices according to the rules approved by the Decision of the Council of the Eurasian Economic Community No. 46 dated February 12, 2016. However, this procedure is still carried out within the framework of the national legislation of the Republic of Belarus (during the transitional period until December 31, 2021), since the documents for registration procedures within the framework of the Eurasian Economic Community are under development.

registration of honey products Belarus
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What medical devices are subject to registration
Medical products are products for prophylaxis, research, diagnostics, rehabilitation and treatment. For example, hemostats, gloves, syringes, catheters, canes. Auxiliary materials (containers, packaging, fixtures, etc.) are also classified as such products. Registration is required for medical devices that:

first created and not previously used in the Republic of Belarus;
are analogues of previously registered, but from another manufacturer;
will be used for a new indication;
foreign production and first used in the Republic of Belarus.
In this list, products of domestic and foreign production are not in vain. This affects the registration process. Registration is not necessary for the following medical devices:

produced in the Republic of Belarus by order of foreign legal entities, but intended for use outside the Republic of Belarus;
accessories and spare parts for already registered products;
raw materials and materials for products manufactured in Belarus;
for which permission of the Ministry of Health of the Republic of Belarus for distribution, application in the Republic of Belarus;
imported into the Republic of Belarus by an individual for personal use only.
Since different materials are used for the manufacture of such products, their purpose differs, it is necessary to refer to the relevant standards and norms during the registration process or in preparation for it.

registration of honey products Belarus
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How is the registration
8 stages of registration of medical devices in the Republic of Belarus

The procedure is obligatory for medical products of foreign and domestic production.

1. Apply
If you are an importer or manufacturer, then you need to contact the Unitary Enterprise "Center for Expertise and Testing of Health Care", which registers medical devices in Belarus.
2. Collect all necessary documents.
You will need regulatory and operational documentation.
3. Submit them for initial analysis.
Experts review the documentation and determine the need for various tests and / or inspection control of production.
SHOW ALL STAGES

To register the registration of medical products, you must follow the procedure from the above-mentioned decree of the Council of Ministers of the Republic of Belarus. The applicant may be a legal entity or an individual entrepreneur. At the same time, he may be the customer of manufacture, and not the direct manufacturer. The applicant will face the following stages of registration of medical devices:

Registration of the registration dossier and its submission to a specialized organization.
Primary examination of documentation.
Inspection of production (if a new manufacturer of medical products of classes 2 and 3 of danger).
Conducting various tests: technical, sanitary and hygienic, clinical.
Conducting specialized expertise of documentation.
Decision on registration by the Commission of the Ministry of Health of the Republic of Belarus.
Registration of the registration certificate.
Logging into the database.
Getting a certificate.
The certificate is valid for 5 years. It is made out on the form of the established sample with protection. The preliminary technical work is carried out by the Center for Expertise and Testing in Health Care, its specialists determine the need and type of testing based on the data obtained from the documentation. The same organization issues an opinion and is responsible for maintaining the identity registry. The ministerial commission can stop the registration of medical devices in Belarus if there is a lack of any data confirming the safety, efficiency and quality of the products presented.

Important: The presence of a registration certificate for a specific medical device is a prerequisite for obtaining tax benefits.

Documents for registration of medical devices
Domestic production:

Application for registration.
Technical regulations from the manufacturer with the method of verification.
Protocols and (or) acts of technical tests.
Protocols and (or) acts of sanitary and hygienic tests.
Protocols and (or) acts of clinical trials.
Instructions for use on a specific product model.
Conclusion
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When to re-register
It is necessary to contact the specialized organization for the official renewal of the certificate. Re-registration pass, if:

the validity period of the previously received certificate of registration has expired;
product name has changed;
the manufacturer has changed the name or there was a reorganization;
production country has changed;
Amendments to the technical regulations for the medical device have been made.
These reasons for re-registration of medical devices are described in the above Resolution of the Council of Ministers of the Republic of Belarus.

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How to more effectively and faster to register
To register the registration of medical products in Belarus as soon as possible, it is important to gather all the necessary documentation. This will avoid comments after the initial examination, which requires time-consuming repairs. Additionally, you can contact the experts with experience in this field. In other countries, different organizations are engaged in this, so qualified assistance for those who want to enter the international market will be extremely useful. Indeed, each country has its own list of goods subject to the CGR (state registration).

 registration of honey products Belarus


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