海关联盟EAC认证中心

Центр сертификации Таможенного союза

021-36411223      Skype:gostchina


乌克兰医疗器械注册 UKRAINE – REGULATION FOR MEDICAL DEVICES
    发布时间: 2018-09-20 09:16    

201571日,医疗器械的上市许可要求发生了变化:国家注册体系已被国家对技术法规的符合性评估所取代。乌克兰技术法规基于相关的欧盟指令93/42 / EEC98/79 / EC90/385 / EEC

监管框架

- 医疗器械的评估一致性 - 乌克兰内阁于2013102日起的决议№753

- 体外诊断设备的评估一致性 - 乌克兰内阁于2013102日起的决议№754

- 有源植入设备的评估一致性 - 乌克兰内阁的决议№7552013102日起


乌克兰医疗器械注册

UKRAINE – REGULATION FOR MEDICAL DEVICES

201571日,医疗器械的上市许可要求发生了变化:国家注册体系已被国家对技术法规的符合性评估所取代。乌克兰技术法规基于相关的欧盟指令93/42 / EEC98/79 / EC90/385 / EEC

监管框架

- 医疗器械的评估一致性 - 乌克兰内阁于2013102日起的决议№753

- 体外诊断设备的评估一致性 - 乌克兰内阁于2013102日起的决议№754

- 有源植入设备的评估一致性 - 乌克兰内阁的决议№7552013102日起。


*分析仪试剂和其他LVD产品,未列入体外诊断医疗器械技术法规“A”和“B”清单(CMU No 754法令)

**体外:自我测试设备。体外诊断医疗器械技术法规“A”和“B”清单的校准和控制材料(CMU No 754法令)

国家符合技术法规的程序取决于MD的等级,允许某些类别在工厂检查和批量验证之间进行选择。

MD类定义了指定NB机构的参与证书类型:

1、这类产品可以通过乌克兰技术法规的自我声明合规程序投放市场。   

2、其他MD产品要求对生产现场进行文件评估和工厂检查,该认证将颁发证书5年,或者按照每批进行合格评定行,以获得确切单批装运的证书。

 

乌克兰授权机构的合格评定需要的产品包括:

- I类无菌医疗器械,测量医疗器械,IIaIIbIII类所有医疗器械,按照医疗器械技术法规的规定(CMU753法令),

- 体外:自检装置;体外诊断医疗器械技术法规“A”和“B”的试剂,校准和控制材料(CMU754法令),

- 根据有源植入式医疗器械技术法规的所有有源植入式医疗器械(CMU754法令)。

 

可以使用以下途径之一,乌克兰授权NB认证机构参与的合格评定程序2种类型:

1、评估生产现场的质量管理体系(工厂检查)合格证书:从而颁发有效期为5年的MD合格证书,该证书与质量管理证书有效期为3年。

2、每批次的合格证书:即在文件专业知识和样本检查之后颁发MD的特定单次(装运)证书。

自我声明适用于:

根据医疗器械技术法规(CMU№753法令)的规定,没有测量功能的I级风险级医疗设备,非无菌的;

分析仪,试剂和其他IVD*产品,未包含在体外诊断医疗设备技术法规“A”和“B”列表中(CMU№754法令)

完整的质量保证体系证书注册流程



 

与批量验证程序相比,制造商质量管理体系的符合性评估程序是更全面,耗时且成本更高的程序。但从长远来看,第四阶段的评估的成本可能超过制造现场审查的成本。

 

 

 

 

 

 

乌克兰医疗器械注册

UKRAINE – 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

At July 01, 2015 marketing authorization requirements for medical devices have changed: system of state registration has been replaced by national conformity assessment to Technical regulations. Ukrainian Technical Regulations are based on relevant EU Directives 93/42/EEC, 98/79/EC and 90/385/EEC.

 

| Regulatory framework

-assessment conformity of medical devices – resolution by Cabinet of Ministry of Ukraine №753 from 02.10.2013,

-assessment conformity of in vitro diagnostic devices – resolution by Cabinet of Ministry of Ukraine №754 from 02.10.2013,

-assessment conformity of active implantable devices – resolution by Cabinet of Ministry of Ukraine №755 from 02.10.2013


Procedure of national conformity to Technical regulations depends on class of MD and allows for some classes to choose between factory inspection and batch verification.

Class of MD defines need for involving of notified body: safest products can be put into the market through self-declaration conformity procedure to Technical regulation of Ukraine. Other MD require documentation assessment and factory inspection of the manufacturing site that will grant certificate for 5 years, or to follow every-batch conformity assessment that result to certificate for exact shipment.

Conformity assessment involving authorized body is required for:

-Sterile medical devices of I class, measuring medical devices, all medical devices of classes IIa, IIb, III according to provision of Technical regulation on medical devices (Decree of CMU №753),

-In-vitro: self-testing devices; reagents, calibration and control materials of lists “A” and “B” of the Technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754),

-All active implantable medical devices according to Technical regulations on active implantable medical devices (Decree of CMU №754).

The conformity assessment procedure with the involvement of the notified body may be applied using one of the following routes:

§  Assessment of the Quality Management System at the manufacturing site (factory inspection), which results in issuing of the conformity certificate for MD valid for 5 years related to the quality management certificate valid for 3 years.

§  Conformity assessment of each batch, which mean issuing of the certificate for the certain batch (shipment) of MD after documentary expertise and sample examinations.

 

Self-declaration is applied to:

§  Medical devices of I risk class, not sterile, without measuring functions according to provision of Technical regulation on MD (Decree of CMU №753);

§  Analyzers, reagents and other IVD products, which are not included in the lists “A” and “B” of the Technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754)



Conformity assessment of manufacturer quality management system is more comprehensive, time-consuming and costly procedure in comparison with the batch verification procedure. But in the long term perspective the estimated costs for the fourth-fifth batch assessment may exceed those for manufacturing site inspection.

021-36411223 
eac@cu-tr.org
www.cu-tr.org