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ABOUT MEDREGISTRATION COMPANY
Medregistration Consulting Agency was founded in 2019. Since its foundation more than 120 registration certificates have been received. Our specialization is both foreign and Russian medical devices.
The founders of the agency are key employees of the company with relevant experience in the regulatory affairs departments of representative offices of the largest foreign manufacturers of medical devices for more than 10 years.
Our specialists have specialized education, are fluent in English, have extensive experience working in representative offices of foreign manufacturers, regularly participate in seminars of Roszdravnadzor and expert organizations, industry forums, as well as we have established cooperation with testing laboratories. Thanks to such experience, you will receive well-founded and backed up by references to current legislation answers to all questions of interest not only on registration, but also on labeling, project planning (risk-oriented best case/worst case planning), as well as assistance with answers to questions from foreign colleagues, preparation of any necessary documents and information in English.
REFERENCES
Thank you for your consultations on the description of the EAEU registration processes, labeling of medical devices, as well as professional support of the VIRD of our product. We recommend you as a responsible and reliable partner
Buiko Ekaterina
Director of Regulatory Affairs Russia and Eurasia LLC "Teva"
Thank you for your promptness, proffessionalism and integity in your work during registration of our devices. We hope for further cooperation
Asher Bazak
QA&RA Consultant Alpha-Bio Tec., Ltd., Israel
All stages of registration of our product were completed on time, efficiently, under optimal financial conditions and with an individual approach
Roman Nazarenko
General Director of Med Life Sciences LLC
The company's employees proved themselves to be professionals in their field, quickly and efficiently prepared all the necessary documentation, accompanied clinical trials and controlled the entire registration process
Bolshakov A.S.
General Director of VIAK LLC
During the preparation of documents and registration of our product, employees contacted the manufacturer in English and promptly prepared documentation in two languages. We recommend you as a professional partner in the field of registration
Gulyaev P.S.
General Director of SIBMK LLC
The expert was always in touch by phone and mail, promptly prepared documents and explained in detail the procedure for legalization and registration of documents. Thank you for accompanying the procedure for making changes to the dossier
Wall S.I.
General Director of Vital Rise LLC
OBTAINED REGISTRATION CERTIFICATES
EXAPLES OF REGISTERED DEVICES
Implants
Dental implants manufactured
Covid-19 IgM IgG tests
Express test for detection of IgM, IgG antibodies to Covid-19 manufactured
Kits
Kits for the introduction of radiopaque substances manufactured