01Assessment
What localization can achieve
The operations and components needed for Russian-origin status, and its implications for public procurement.
Outcome: an assessment of whether status is achievable
Localization
Medical device manufacturing localization in Russia
We help relocate medical device manufacturing to Russia to obtain Russian-origin product status. We analyze operations and components and prepare documents for the Ministry of Industry and Trade's Russian industrial product register and, where needed, ST-1 certification. This opens access to public procurement preferences for Russian products.
A device description and production overview are enough for the first conversation.
- 450+ projects of any complexity
- Direct contracts with laboratories
- One expert from start to finish
What you receive
Russian-origin status, step by step
Assessment, register documentation and dossier amendments.
02Documents
Manufacturing and the register
Production and technical documentation, QMS documents, and an application for the Ministry of Industry and Trade register or an ST-1 certificate.
Outcome: an application for register inclusion or ST-1
03Registration
Alignment with the dossier
Dossier and certificate amendments if localization changes the manufacturer or manufacturing facility.
Outcome: an up-to-date dossier and certificate
How localization works
Localization usually runs alongside production preparation and dossier amendments.
01
Assessment
We analyze operations, components and the facility.
Outcome: requirements for the status02
Manufacturing
We prepare documentation and QMS processes.
Your own or a partner's facility03
Register
We submit documents for register inclusion or ST-1 certification.
Timings follow the authority's procedure04
Dossier
We amend the registration certificate if the manufacturer or facility changes.
Outcome: Russian-origin statusWhy clients choose us
Registration without detours and lost months
We do not sell template packages. Every project starts with analyzing the device, so the documents pass the expert review and cause no problems after registration.
We read the dossier like an expert
Our team includes test engineers. They find discrepancies before submission, not after Roszdravnadzor remarks.
We write documentation from scratch
No specifications or operating manual? We will develop them. Have them but with errors? We will refine them so that everything matches.
One expert from start to finish
One specialist runs your project. They coordinate with the manufacturer and laboratories and are always available.
Devices of any complexity
From dressings to anesthesia units, X-ray equipment and implants. More than 450 projects in 10 years.
We examine the device design, components, manufacturing process and facility capabilities, then define the sequence of work and information to prepare.
What we help with
- Assessing the initial project and selected manufacturing facility.
- Developing manufacturing and assembly operations and production and technical documentation.
- Preparing quality management processes and documents.
- Aligning manufacturing information with the medical device registration dossier.
- Preparing proof-of-origin documents, ST-1 materials or an application for the Russian industrial product register, depending on the project.
ST-1 and the Ministry of Industry and Trade register
We first clarify why proof of origin is needed: public procurement, register inclusion or export. We then review product, component and operation documents and give a direct assessment: whether the current setup can achieve the status and, if not, what needs to change.
What is needed for an initial discussion
A description of the device and models, manufacturer details, production overview, component list and proposed facility information. If the device is already registered, current documentation is needed to assess the required amendments.
Work plan
Localization is rarely a standalone service: it usually combines production preparation, QMS documentation and registration dossier amendments. We build these into a project-specific plan with a deliverable at every stage.
Related areas: manufacturing and assembly at partner facilities, QMS and ISO 13485, registration dossier amendments.
Trusted by
Chosen by those who cannot afford a mistake in the dossier
Developers of devices for military medicine, defense enterprises, Russian plants and manufacturers from China, Türkiye, Korea and Germany. Below are our partners and signed and sealed letters of appreciation.
Appreciation from the Burdenko Main Military Clinical Hospitalfor professionalism and contribution to the domestic medical industry
Talk at the Military Medicine of the 21st Century conferencethe conference is organized by the S. M. Kirov Military Medical Academy
Letters from VIKor, SigmaPharm, Implant Engineering and many othersThis list grows with every project. Signed and sealed letters are collected below on this page.
Our partners
Planning to manufacture in Russia?
We will analyze operations and components and explain what is needed for register inclusion or an ST-1 certificate.
Discuss localization ↗- 15+engineers and specialists
- 10+ yearsof experience among our leading specialists
- 450+projects of any complexity
Have questions or need a consultation?
What would you like help with?
- We will look into your task and suggest where to start
- After the review we send a plan: stages, timeline and cost
- You talk directly to the specialist who runs the project