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State registration of medical devices in the Russian federation and the eaeu
More than 10 years of experience in medical devices regulatory affairs field
Regular monitoring of current changes in the sphere of medical device circulation in the legislation of the Russian Federation and the EAEU
Accelerated preparation of documents for the fastest possible device launch on the market
Registration of medical devices is a necessary procedure for their circulation in the territory of the Russian Federation and the EAEU.
The registration timeline depends on the characteristics of your device, its type and risk class, as well as on the timing of the provision of documents and information by the manufacturer.
Registration of the 1st risk class medical devices in the EAEU takes 2-12 months
Registration of the 2а risk class medical devices in the RF takes 6-12 months
The cost of consulting agency's services is fixed. Payment is made in stages. We ensure transparency of all payments.
TIMELINES
BUDGET
The budget for registration composed of following components:
Registration of 2a sterile (and upper) risk class medical devices in the EAEU takes from 12 months
Consulting agency services
Services of testing laboratories/centers
Services of translation agencies
State duties
Inspection of manufacturing site (for registration under the EAEU)
Preparation of a complete set of documents of the registration dossier, full support of the registration process before the obtaining of registration certificate
Organization and support of technical, toxicological, EMS, clinical and clinical laboratory tests.
Development of technical, operational documentation, as well as other separate documents of the registration dossier in Russian and English
Obtaining a permit for the import of medical devices into the territory of the Russian Federation
OUR SERVICES
Analysis and assessment of compliance of the registration dossier with regulatory requirements before the dossier submission to Roszdravnadzor
We provide a wide range of services, including not only obtaining registration certificates and making changes to already received registration certificates, but also:
Preparation and submission of letters and appeals to Roszdravnadzor and expert organizations on any issues
Determination of nomenclature classification code in accordance to EAEU legislation
Consultations on the circulation of medical devices in the Russian Federation and the EAEU for foreign manufacturers in English language in any convenient format
Correction of technical errors and typos in registration certificates
Consultations on any regulatory issues with references to legislation
Request of registration dossiers from the archive of Roszdravnadzor
Preliminary assessment of device to the category of medical products
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COMFORTABLE COOPERATION FOR YOU
We form and provide for our clients an electronic archive of the registration dossier submitted to Roszdravnadzor
We stay in touch with the client 24/7 in any convenient format (email, whats app, regular phone calls and participation in conference calls)
Prepare documents in Russian and English for approval with the manufacturer
We adapt to your deadlines and prepare documents in an accelerated mode
REFERENCES
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We will call you back within 20 minutes and advise you in detail on any issues of registration and circulation of medical devices in the Russian Federation and the EAEU
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© 2021 LLC "Medregistration"
INN: 7713477889, OGRN: 1207700364740
INN: 7713477889, OGRN: 1207700364740
What we do