Registration of medical devices of all types and risk classes in Russia and EAEU
Our goal is not only to bring the device to the market as quickly as possible, but also to prepare a high-quality dossier that fully corresponds to your product, which passes the checks of Roszdravnadzor during state control
Пройдите небольшой опрос для того чтобы мы смогли сформировать вам предложение
Введите свои данные и мы скоро свяжемся с вами
ABOUT COMPANY
"Medregistration" consulting agency provides services on accompaniment of registration of wide range of medical devices, all types and classes of risks, including equipment and IVD (in vitro diagnostic) devices. Our specialization is both foreign and Russian medical devices. Our specialist are team of professionals with long-term experience in the regulatory affairs field in foreign medical devices manufacturers. All specialist are fluent in English and have specialized education.
Registration of medical devices is a necessary procedure for their circulation in the territory of the Russian Federation and the EAEU.
The document confirming the fact of state registration is the registration certificate
Accelerated preparation of documents for the fastest possible device launch on the market
Compliance with the company's Code of Ethics, confidentiality of customer data
open system of communication and interaction with the client in any convenient format (e-mail, what's app, phone calls)
OUR ADVANTAGES
Effective cooperation with testing laboratories and clinical organizations
Transparent in stages payment terms
COMPLIANCE
EXPERIENCE
COMMUNICATION
TIMELINES
PAYMENT TERMS
COOPERATION
More than 10 years of experience in medical devices regulatory affairs field
REGISTRATION OF MEDICAL DEVICES
DOSSIER AMENDMENT
REMARKS ELIMINATION
ADDITIONAL SERVICES
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