01Applicability
An answer before work begins
We check whether your materials and components qualify for relief before preparing documents.
Outcome: a yes-or-no assessment
Manufacturing and documentation
Documentation for VAT exemption on medical device materials and components
We prepare documents confirming that materials and components are intended for medical device manufacturing, providing a basis for VAT relief. We first check whether the relief applies to your products and only then prepare the package, so you do not spend time unnecessarily.
A component list and device description are enough for the first conversation.
- 450+ projects of any complexity
- Direct contracts with laboratories
- One expert from start to finish
What you receive
An answer first, documents second
We do not prepare the package until we have checked that the relief applies.
02Package
Supporting documentation
Documents substantiating the intended use of materials and components in medical device manufacturing.
Outcome: supporting document package
03Ongoing support
Responses to questions
We address questions and comments on the documents through to confirmation.
Outcome: confirmation without outstanding comments
How document preparation works
We check applicability first, then prepare the package.
01
Review
We compare the list with the device and applicable requirements.
Outcome: an applicability assessment02
Documents
We prepare evidence of intended use.
Specifications, technical requirements, links to the device03
Alignment
We check the package for discrepancies.
Before the documents are delivered04
Ongoing support
We answer questions about the documents.
Outcome: confirmationWhy 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.
Scope of support
- Analyzing the materials and components list and its connection to the medical device.
- Reviewing source technical documents and supporting evidence.
- Identifying missing information and preparing the package for the selected procedure.
- Support with questions and comments on the documents.
What to clarify before starting
The tax authority decides whether relief applies. Our role is to prepare clear documentation with an accurate list of items, their intended use and their connection to a specific device.
For an assessment, we need a device description, a component list with intended uses, technical documentation and manufacturing information.
Related services: medical device localization and manufacturing and assembly preparation.
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
Find out whether your products qualify for relief
Send the component list and device description. We will give you an answer before starting work.
Discuss your documents ↗- 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