Amendments to the registration dossier

Service: Amendments to a Registration Dossier (Medical Devices)

Company Elibrum provides comprehensive support for making amendments to the registration dossier for medical devices. The service starts from 350,000 RUB.

What the service includes

1. Addition of products
   Inclusion of new medical devices into the dossier. The scope covers:

   • preparation of a complete document package for each device;

   • coordination with regulatory authorities;

   • end‑to‑end registration support until data are entered into the official registry.

2. Amendments to existing products
   Updating information on already registered devices (e.g., changes to specifications, комплектации, or materials). Includes:

   • assessment of whether expert evaluation is required;

   • preparation of supporting documentation;

   • liaison with Roszdravnadzor.

3. Change of product labelling
   Updating information on packaging, labels, and accompanying materials. Covers:

   • compliance verification against current requirements;

   • design of new label layouts;

   • approval of changes with regulatory bodies.

4. Removal of products
   Official exclusion of devices from the registration dossier (e.g., upon discontinuation). Includes:

   • preparation of justifying documents;

   • notification of regulators;

   • updating the registry.

5. Amendments to technical specifications (TS) / technical file
   Updating technical documentation due to production upgrades or regulatory changes. Covers:

   • review of current TS/technical file;

   • development of updated versions;

   • coordination with experts and regulators.

6. Amendments to the instructions for use
   Updating the device’s user manual (e.g., expanding indications or clarifying contraindications). Includes:

   • assessment of whether clinical data are needed;

   • revision of text to meet regulatory requirements;

   • approval of the updated version.

7. Addition of a trademark
   Inclusion of information about a new brand or logo in the dossier. Covers:

   • legal clearance check of the designation;

   • preparation of registration documents;

   • update of registration data.

How the process works

1. Situation analysis
   Expert assessment of existing documents and identification of required changes.

2. Documentation preparation
   Drafting and formatting all required forms, protocols, and justifications.

3. Regulatory liaison
   Support through approval procedures with Roszdravnadzor and expert organisations.

4. Timeline and status monitoring
   Tracking document review stages and prompt resolution of any issues.

5. Final result delivery
   Recording changes in the registry and handing over the updated dossier to the client.

Key considerations

• Regulatory framework: work is carried out in accordance with Resolution of the Government of the Russian Federation No. 1684 dated 30.11.2024 and other relevant regulations.

• Timelines: depend on the type of changes and regulator workload (typically 1–6 months).

• Additional costs: may include state fees, expert evaluation, or testing (calculated individually).

• Guarantee: all changes are made in compliance with legal requirements, minimising the risk of rejection.

Why choose Elibrum

• Experience: a team of specialists with years of practice in medical device registration.

• End‑to‑end approach: full support from analysis to receipt of the final document.

• Transparency: clear timelines, staged payments, regular progress reports.

• Legal support: protection of client interests in case of disputes.

How to order the service

To discuss your case or place an order, please contact us:

• Address: 17 Mozhaiskaya St., Saint Petersburg, Russia;

• Phone: +7 (921) 635‑85‑05.