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Certification of medical devices


GOST R certificate of conformity


Limited Liability CompanyCertification Centre of Medical Equipment VNIIMP (LLC CCME VNIIMP) is one of the leaders among organizations which carry out certification of domestically produced and imported medical devices in Russia. LLC CCME VNIIMP Certification Body and Test Laboratory are accredited by GOSSTANDART of Russia (now as Federal Agency on Technical Regulating and Metrology) in certification of a wide range of medical products. The staff of LLC CCME VNIIMP consists of highly qualified specialists. Most of our fellows have had over twenty years experience of working in the field of standardization, metrology, certification and testing medical products.

If you want to get a GOST R certificate of conformity for your medical product(s) you shouldcome in our office with the documents, prepared according to The list of the documents, required for certification. Also you should fill in The application for certification of products. If your medical product is supplied with the accessories you should fill in The annex to the application for certification of products and bring the list of the accessories in electronic form with you or send it by e-mail to us. Feel free to contact us concerning any questions about the filling in the forms. Our staff members will gladly discuss all your questions by phone + 7 (495) 611-00-57 or personally during your visit to our office.

We will review your documents during your visit to our office and define the cost, terms and conditions of the certification process, prepare an invoice.

Kindly request you to get through to us by phone +7 (495) 611-00-57 and make an appointment. It helps us to organize our cooperation in the best way and to avoid any troubles.

Please, do not hesitate to contact us by phone +7 (495) 611-00-57 if you have any questions. Also you could make a request/order a certification service at our website item "Make a request".


Customs letters


If your organization needs to carry out customs clearance of medical devices, imported into the territory of the Russian Federation as samples for testing with the purpose of their certification or as samples for registration in the Ministry of Health (now as Federal Service for Surveillance in the Sphere of Healthcare and Social Development (Roszdravnadzor)) with the purpose of their certification. And these medical devices belong to the products, for which the confirmation of carrying out the obligatory certification is required when releasing in the customs territory of the Russian Federation. We could help you to release the following products without the presentation of certificates of conformity in the territory of the Russian Federation in the following way:

1.You should fill in The application for certification of products. If your medical product is supplied with the accessories you should fill in The annex to the application for certification of products.

2.Based on the filled application, Certification Body draws up and registers a customs letter. The quantity of the medical devices that might be released in the customs territory of the Russian Federation and the purpose of the release are noted in this customs letter.

3.You should give the original of the customs letter and a copy of the application for certification of products attested by Certification Body to Customs.

You should pay attention that in this way of releasing in the customs territory you have to conduct the certification of these medical devices in our Certification Body or in another certification body, accredited for the right of conducting the certification of these particular medical devices, at a later time.

Kindly request you to get through to us by phone +7 (495) 611-00-57 and make an appointment. It helps us to organize our cooperation in the best way and to avoid any troubles.

Please, do not hesitate to contact us by phone +7 (495) 611-00-57 if you have any questions. Also you could make a request/order a certification service at our website item Make a request.


Help foreign manufacturers in getting a certificate of registration


According to Russian law, all medical products should be registered with the Ministry of Health (now as Federal Service for Surveillance in the Sphere of Healthcare and Social Development (Roszdravnadzor)) before being imported, sold and used in the territory of the Russian Federation. Usually foreign manufacturers do not completely understand the registration process. And, in general, the registration process is too long.

We can satisfactorily explain the registration process to you, help to prepare the required set of documents and help to register your medical device(s) quickly. If you are interested in this service, please, contact us by phone +7 (495) 611-17-38. The contact person: Mashkov Aleksander Vladimirovich, the director of LLC CCME VNIIMP.

You could make a request at our website item Make a request.


Attached files:


filesizelast edited
The list of the documents, required for certification 24 kb 23.01.2007 download
The application for certification of products 27.5 kb 23.01.2007 download
The annex to the application for certification of products 45.5 kb 26.01.2007 download
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