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Certification of Medical Equipment for Russia
Certification of Medical Equipment for Russia
It is carried out in the form of declaration. The conformity declaration is issued based on the GOST-R system. Virtually all types of this equipment must be declared, this is due to the fact that it is associated with ensuring the health of people, and therefore is under the close control of the state.
Taking into account the specificity of tests, examinations and conclusions when assessing compliance, there is a subsystem of state. Certification GOST R known as the "system of medical certification", which is used in the preparation of Declaration of Conformity for medical equipment.
The system is located in the Ministry of Health and Social Development of the Russian Federation. To issue certificates of conformity for medical equipment, a limited number of certification bodies are accredited due to the fact that permits are issued only by the Ministry of Health of the Russian Federation, The permission for its operation is quite expensive and long.
The certificate of state registration (PGR) is contained in the list of necessary documents required by the Ministry of Health of the Russian Federation and is mandatory when preparing the Declaration of Conformity for medical equipment. This requirement applies to special medical equipment, as well as drugs during the first release into circulation.
Such a requirement applies to domestic and imported equipment, as well as products. First, such products are entered in the State Register of Preparations approved for trafficking in the Russian Federation, and then the Registration Certificate of the Ministry of Health of the Russian Federation is issued for it. The implementation of this procedure is based on the Administrative Regulations of the Federal Service, introduced in 2006 by the order of the Ministry of Health of the Russian Federation No. 735.
This requirement relates to the following medical facilities:
- Tools and materials;
- Special equipment in the list approved by the Ministry of Health of the Russian Federation;
- Special software and hardware, incl. Included in the supply of special medical equipment;
- Other medical devices.
Prior to issuance of a permit, certification tests of preparations or devices are mandatory, after which a test report is prepared in which the results are contained, as well as their compliance with specified document parameters. Tests of medical equipment are conducted in the appropriate order.
In the Russian Federation, there are 3 different forms of Medical Permits that operate from 5 to 10 years, this period depends on the type of equipment or product and is indicated directly in the Permit.
The presence of an extract from the Commission's decision on new medical equipment is a prerequisite. It operates for two years. The application should be accompanied by a technical description and instruction manual.
If it is planned to import medical equipment not from the territory of the Customs Union (TC), then it is required to obtain an Expert Opinion. Such a requirement is approved by the decision of the TC Commission, with the HS code of medical devices in the group that is in the first section of the list of goods of the Customs Union, which are ordered to undergo sanitary inspection if they cross the border of the TS.
In addition to certificates or declarations of compliance, there is one more requirement for medical devices - the licensing of maintenance. Only companies licensed to manufacture can be manufacturers of medical equipment in the Russian Federation. In developed countries the same way. The ministries of health in the producing countries carry out state registration of the produced equipment, and manufacturers are required to have special permits for its production.
Taking this into account, issuing Certificates of Conformity for imported medical equipment is required to have permits issued in the countries of production. The documents must be translated into Russian and notarized.
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Taking into account the specificity of tests, examinations and conclusions when assessing compliance, there is a subsystem of state. Certification GOST R known as the "system of medical certification", which is used in the preparation of Declaration of Conformity for medical equipment.
The system is located in the Ministry of Health and Social Development of the Russian Federation. To issue certificates of conformity for medical equipment, a limited number of certification bodies are accredited due to the fact that permits are issued only by the Ministry of Health of the Russian Federation, The permission for its operation is quite expensive and long.
The certificate of state registration (PGR) is contained in the list of necessary documents required by the Ministry of Health of the Russian Federation and is mandatory when preparing the Declaration of Conformity for medical equipment. This requirement applies to special medical equipment, as well as drugs during the first release into circulation.
Such a requirement applies to domestic and imported equipment, as well as products. First, such products are entered in the State Register of Preparations approved for trafficking in the Russian Federation, and then the Registration Certificate of the Ministry of Health of the Russian Federation is issued for it. The implementation of this procedure is based on the Administrative Regulations of the Federal Service, introduced in 2006 by the order of the Ministry of Health of the Russian Federation No. 735.
This requirement relates to the following medical facilities:
- Tools and materials;
- Special equipment in the list approved by the Ministry of Health of the Russian Federation;
- Special software and hardware, incl. Included in the supply of special medical equipment;
- Other medical devices.
Prior to issuance of a permit, certification tests of preparations or devices are mandatory, after which a test report is prepared in which the results are contained, as well as their compliance with specified document parameters. Tests of medical equipment are conducted in the appropriate order.
In the Russian Federation, there are 3 different forms of Medical Permits that operate from 5 to 10 years, this period depends on the type of equipment or product and is indicated directly in the Permit.
The presence of an extract from the Commission's decision on new medical equipment is a prerequisite. It operates for two years. The application should be accompanied by a technical description and instruction manual.
If it is planned to import medical equipment not from the territory of the Customs Union (TC), then it is required to obtain an Expert Opinion. Such a requirement is approved by the decision of the TC Commission, with the HS code of medical devices in the group that is in the first section of the list of goods of the Customs Union, which are ordered to undergo sanitary inspection if they cross the border of the TS.
In addition to certificates or declarations of compliance, there is one more requirement for medical devices - the licensing of maintenance. Only companies licensed to manufacture can be manufacturers of medical equipment in the Russian Federation. In developed countries the same way. The ministries of health in the producing countries carry out state registration of the produced equipment, and manufacturers are required to have special permits for its production.
Taking this into account, issuing Certificates of Conformity for imported medical equipment is required to have permits issued in the countries of production. The documents must be translated into Russian and notarized.
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ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "ТЕСТ СЕРТ"
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