About Company

GrandLocus Medical — Medical Device Manufacturers Support
Center (MDMSC) — 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.

GrandLocus Medical (MDMSC) strives not only
to expedite registration and ensure compliance with
all requirements, but also to become a long-term strategic partner, strengthening the position
of manufacturers in the market.

«My team and I work for those who strive to develop technologies, improve the quality of treatment, and improve the lives of
patients. And we are ready to walk this path together».

My expertise spans over 18 years of experience in medical device registration. My professional journey encompasses in-depth expertise
in working with high-risk devices, complex equipment, and innovative solutions from leading global manufacturers.

My experience:

2018-2025 — Head of the Registration Department  
at the Mindray Russian representative office

2007-2018 — head of the registration department  
of the TERUMO Russian representative office

Over the years, we have accumulated vast experience and formed
an extensive professional network, including leading testing
laboratories and medical institutions.

Natalya Sysoeva

General Director

Company mission

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.

«My team and I work for those who strive to develop technologies, improve the quality of treatment, and improve the lives of patients. And we are ready to walk this path together».

My expertise spans over 18 years of experience in medical device registration. My professional journey encompasses in-depth expertise in working with high-risk devices, complex equipment, and innovative solutions from leading global manufacturers.

Мой опыт:

2018-2025 — руководитель отдела регистрации  в российском представительстве компании Mindray

За эти годы накоплен огромный опыт и сформирована обширная профессиональная сеть, включающая ведущие испытательные лаборатории и лечебные учреждения.

Natalya Sysoeva

General Director

My experience:

2018-2025 — Head of the Registration Department  
at the Mindray Russian representative office

2007-2018 — head of the registration department  
of the TERUMO Russian representative office

Over the years, we have accumulated vast experience and formed
an extensive professional network, including leading testing laboratories and medical institutions.

Company mission

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.

In MDMSC we built a system approach as base for our work, combining regulatory expertise, knowledge of regional market requirements, and an understanding of the manufacturer's objectives.

We help you see the whole picture. Registration is just one step. Coordination is essential between the registration dossier, supply strategy, sales, safety monitoring, and post-registration obligations.

Planning

Already at the pre-registration stage, we establish solutions that will ensure stability and manageability throughout all subsequent stages:

How will the products be imported,

How to complete a Registration Application taking into account sales and logistics requirements,

How will clinical data be collected and processed for post-registration monitoring,

Which stages can be run in parallel (e.g., developing
a dossier, selecting a testing laboratory, preparing production documentation) to reduce the overall time
to market,

What are the specific features of your product type: specific regulatory requirements, specific testing, manufacturing,
or labeling requirements,

Typical laboratory comments for products of your class and purpose - and how to minimize them,

What should be prepared in advance (technical specifications, manufacturer's reports, drawings, production data) to ensure a continuous, uninterrupted registration process.

Specialization on location

When working with localized products, consistency across all stages is especially important:

Determination of criteria for recognizing a product as domestic in accordance with the Decree of the Government of the Russian Federation No. 719: the share of Russian components, the performance of key technological operations on the territory of the Russian Federation, compliance with the requirements for documentary confirmation,

Putting into production and processing documents in the correct chronological sequence,

Medical Device state registration,

What information in the dossier should be taken into account the audit of the Chamber of Commerce and Industry of the Russian Federation,

What information should be included in the dossier, considering possible future changes in raw materials and components.

MDMSC ensures transparency, accuracy and speed of processes, helping manufacturers deliver value to patients without delays.

In MDMSC we built a system approach as base for our work, combining regulatory expertise, knowledge of regional market requirements, and an understanding of the manufacturer's objectives.

Planning

Specialization on location

Need a consultation?

Request a free consultation on the registration procedure  and ask all your questions.