Accelerating access
to quality healthcare
GrandLocus Medical (Medical Device Manufacturers Support Center (MDMSC) — company that provides
a wide range of services to support medical device manufacturers entering the Russian Federation and EAEU markets.
Request a free consultation on the registration procedure and ask all your questions.
Accelerating access
to quality healthcare
GrandLocus Medical (Medical Device Manufacturers Support Center (MDMSC) — a company that provides a wide range
of services to support medical device manufacturers entering the Russian Federation and EAEU markets.
Request a free consultation on the registration procedure and ask all your questions.
from Request to finilizing registration
in the registration of MD (including devices of risk class 3, implantable)
Benefits of working with us
GrandLocus Medical (MDMSC) strives not only to expedite the registration and ensure compliance with all requirements, but also to become a long-term strategic partner, strengthening the position of manufacturers in the market.
and post-registration obligations
со стратегией поставок, реализацией
и пострегистрационными обязательствами
с регулятором
и помочь найти решение в сложных ситуациях
Product registration from 9 months
Registration takes into account post-registration processes
Realistic deadlines with transparent costing
A clear step-by-step plan, a clear status
We offer a wide range of services
We provide a full cycle of medical product launches to the Russian and EAEU markets:
Registration in Federal Service for Surveillance
in Healthcare (Roszdravnadzor) — from document preparation and testing to obtaining a number
in Unified Register of Licence Records;
Localization — we define criteria for domestic origin, carry out registration, and include them in the register of Russian manufacturers;
Post-registration services — clinical monitoring, import and customs, interaction with government agencies.
to enter the Russian
market
to the national procedure of the RF
to the registration dossier/certificate
for a medical device
of production
Get a quote for our services by submitting a request on our website.
About GrandLocus Medical — Medical Device Manufacturers Support Center (MDMSC)
GrandLocus Medical — is a specialized company created
to provide manufacturers with fast, transparent,
and confident entry into the Russian and EAEU markets.
We support manufacturers at every stage: from import
and registration to post-registration monitoring, interaction
with government agencies, and sustainable quality management.
Accelerate the entry of high-quality and safe medical products into the Russian and Eurasian Economic Union markets.
Help manufacturers create in-demand products to provide high-quality patient care.
Accelerate the entry of high-quality and safe medical products into the Russian and Eurasian Economic Union markets.
Help manufacturers create in-demand products to provide high-quality patient care.
Questions & Answers
What is included in the consulting on medical device registration?
We support the entire registration process, from the initial documentation review to
inclusion in the Roszdravnadzor registry. We assist with selecting the appropriate risk
class and type code, drafting technical and operational documentation, assisting with
production audits, developing a post-registration clinical monitoring plan for Type 3
and 2b implantable medical devices, organizing testing and interaction with
Roszdravnadzor. We also provide consultations on post-registration changes.
How long does it take to register a medical device?
The timeframe depends on the risk class, the type of product, the time it takes to prepare samples for testing, and the accuracy of the prepared documentation. Testing takes an average of 3-4 months, and the dossier is held by the Federal Service for Surveillance in Healthcare for 5-6 months. The minimum time for dossier preparation is 3 months.
Our consulting helps reduce the timeframe by ensuring proper preparation at the outset, requesting documents and reports required by the laboratory in advance, and considering which processes can be run in parallel.
Do you help with registration of foreign medical devices?
Yes, we provide consultations on the registration of both domestic and imported medical devices. We provide support with the translation and adaptation of dossiers, select accredited testing laboratories, and support the application process through an authorized representative.
What to do if there is no office in Russia and no Authorized Representative?
To complete the state registration procedure for a medical device, a foreign manufacturer of a medical device must appoint an authorized representative of the manufacturer who will be active during the period the medical device is in circulation in the Russian Federation.
Our company can act as the manufacturer’s authorized representative with a power of attorney from the manufacturer.
What should I do if I have difficulties making payments to Russia?
If you’re having trouble making a payment to Russia, we offer an alternative: payment can be made through our Hong Kong branch in RMB.
What should I do if Roszdravnadzor refuses registration?
We assess the reasons for refusal, make necessary adjustments, provide recommendations for addressing issues, and support resubmissions. We handle all communications with regulators and monitor the dossier’s compliance with requirements to expedite the issuance of registration dossier
Request a free consultation on the registration procedure and ask all your questions.