01Assessment
Which procedure is needed
We determine which changes need expert review, which can be made without it and what needs to be prepared.
Outcome: assessment and work plan
Updating documentation
Amendments to the registration dossier for a medical device
Has the design, documentation, manufacturer or facility address changed? The certificate and dossier details need to be brought into line. Otherwise, the device cannot lawfully be sold or supplied under public contracts. We determine which changes require expert review and which do not, prepare the package and support consideration.
A registration certificate and a description of the changes are enough for the first conversation.
- 450+ projects of any complexity
- Direct contracts with laboratories
- One expert from start to finish
What you receive
A clear deliverable at every stage
Three stages, each with a clear outcome. Pay by stage: see what has been completed and decide whether to proceed.
02Package
Submission documents
Updated documents, a description of changes and an application consistent with one another and with the register entry.
Outcome: a submission-ready package
03Ongoing support
Submission and queries
We submit the package, respond to Roszdravnadzor's requests and check the updated register entry.
Outcome: an up-to-date register entry
How amendments are made
The scope and sequence depend on what has changed. This is a typical route.
01
Review of changes
We compare the new information with the register entry and current dossier.
Time: a few days02
Documents
We prepare new versions and a change description, and arrange testing if needed.
Depends on the scope of changes03
Submission
We prepare the application and package and submit them to Roszdravnadzor.
Review time under the applicable procedure04
Register
We respond to requests and check the updated entry.
Outcome: an up-to-date registration certificateWhy 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.
So that changes do not stop your sales
The manufacturer address changed, a new model appeared, materials or software were updated. Every such change must be reflected in the registration dossier, otherwise the device cannot be legally sold or supplied under public contracts.
What we take on
- We check the changes against the register entry and the current dossier and tell you whether an expert review is needed.
- We prepare new versions of the specifications, operating manual and labeling. If there are no documents, we write them from scratch.
- We submit the package, answer Roszdravnadzor requests and check the updated register entry.
Questions and answers
What to discuss before starting
Brief answers to common opening questions.
Which changes require an expert review?
An expert review is needed when the information affecting the safety and effectiveness of the device changes, for example its design, materials or intended use. A change of the manufacturer name or address usually goes without a review. We give an exact answer after checking the register entry.
How much do the amendments cost?
The cost depends on the scope of changes and whether an expert review is needed. Guide prices are in the price list, and we name the exact amount after the analysis.
What do we need to start?
The registration certificate and a description of what has changed. We will request the rest ourselves.
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
Has something changed in the device or at the manufacturer?
Send the registration certificate and a description of the changes. We will explain which procedure applies and what to prepare.
Discuss your changes ↗- 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