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白俄罗斯医疗器械注册 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

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。

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.

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