REGISTRATION
Circulation of medical devices manufactured both in and outside of Russia requires undergoing the mandatory procedure of their state registration
ACCORDING TO THE RUSSIAN FEDERATION
RULES
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REGISTRATION
Registration according to the EAEU rules is carried out under the Decision of the EEC Council No. 46 “Rules for the registration and examination of the safety, quality and effectiveness of medical devices” dated February 12, 2016
ACCORDING TO THE EAEU RULES
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AUTHORIZED
REPRESENTATIVE OF
THE MANUFACTURER
Following the requirements of the Rules of state registration of medical devices, all foreign manufacturers of medical products which are currently in circulation in Russia should have an authorized representative
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DEVELOPMENT OF
TECHNICAL
DOCUMENTATION
The manufacturer (producer) of the medical device has to develop the documentation in accordance with which one carries out production, manufacture, storage, transportation, installation, setup, use, operation, including maintenance, as well as repair, disposal or demolition of the medical device
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ABOUT US
The company “KC-PROF” has united experts who assist the subjects of medical devices circulation in solving the problems of registration, certification and after-sales support of medical devices and medical equipment. We strive to offer the best and most beneficial solutions for our clients. In our work, we rely on the unique competence, experience, and professionalism of our employees. Here are a few figures to tell you who we are and why people trust us:
100
Certificates received, over
6 years
Our experience in the field
500
Number of projects, over
3
PhD in the
staff
94 %
Clients
satisfaction
9 years
Average term of employment of personnel
27
Geography of our clients: subjects of the RF
18
Foreign clients: number of countries
OUR SERVICES FOR FOREIGN CLIENTS
Registration of medical devices according to
the Russian Federation rules
Registration of medical devices according to the EAEU rules
Introduction of amendments to the registration certificates and the registration dossier
Function of authorized representative of the manufacturer in the Russian Federation
Ko Bum Suk
I.V. Ponomaryov
I.V. Usova
CEO
Project Executive
CEO
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"We are grateful for the professionalism and efficiency demonstrated during the provision of services for supporting the state registration of the medical device Phototherapy device HEALITE II"
"Knowledge and experience of the employees ensured a successful completion of the procedure for amending registration documents for the Yakhroma-Med laser apparatus and for amending the license for the production and maintenance of the above-mentioned apparatus"
"In spite of the significant amount of work and tight deadlines, professionalism, high qualifications and a responsible attitude to work made it possible to prepare all the necessary documents and conduct additional tests as quickly as possible"
OUR PARTNERS
Do you have any questions about our services? Want to learn the cost? It is very simple – just fill out the contact form on the right and we will answer you as soon as possible! Thank you for contacting us.
You can also choose a convenient method of contact out of those described in the “Our contacts” section.
