Amendments to the registration certificate

Service: Amendments to a Registration Certificate (Medical Devices)

Company Elibrum provides a service for making amendments to a Registration Certificate (RC) for medical devices. The service costs 200,000 RUB and covers the following types of amendments:

1. Amendment of the legal address — updating the registered location of the legal entity in the Registration Certificate. Required when the company (manufacturer or authorised representative) changes its address.

2. Change of authorised representative — updating information about the person responsible for communication with Roszdravnadzor (the Russian Federal Service for Surveillance in Healthcare) on behalf of the manufacturer. Includes preparation of documents confirming the new representative’s authority.

3. Change of legal entity — amending the RC in case of company reorganisation (e.g., merger, division, or change of legal form). Requires updating the registration dossier.

4. Addition of a manufacturing site — including information about a new production facility in the RC. Necessary when expanding production or relocating part of the manufacturing process.

Key features of the service

• The procedure is governed by Resolution of the Government of the Russian Federation No. 1684 of 30 November 2024 and other relevant regulations.

• For most of the listed amendments, no re‑examination of the medical device’s quality, efficacy, and safety is required—provided the changes do not affect the device’s characteristics.

• The service package includes:

  • preparation of all necessary documentation;

  • liaison with Roszdravnadzor;

  • end‑to‑end support until the updated RC is issued.

• The turnaround time depends on the complexity of the amendments and the processing speed at the registering authority.

Additional information

• The state fee for amendments that do not require expert evaluation is 2,500 RUB (in accordance with Article 333.32.2 of the Tax Code of the Russian Federation).

• The company can also assist with preparing supplementary documents (e.g., test reports or expert opinions) if needed.

Contact details

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

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

• Phone: +7 (921) 635‑85‑05