Changing manufacturer data
We support changes when changing the name, address, details or other registration information of the manufacturer.
Why choose us
Accurate analysis changesBefore starting work, we evaluate the planned changes and determine the correct procedure for introducing them into the registration dossier.
Risk reductionWe help avoid mistakes when choosing a procedure, reduce review time and minimize the likelihood of comments.
Support to the resultWe control the stages, interact with Roszdravnadzor and expert organizations, we keep the client informed of the work.
When do you need to update your registration dossier?
During the circulation of a medical device, manufacturers are often faced with the need to make changes to the registration dossier. This may be due to changes in product design, technical characteristics, materials, software, labeling, packaging, technical documentation, production site or other information contained in the registration dossier.
Our specialists accompany the procedure for making changes to the registration dossier (VIRD), including cases requiring an examination. We analyze the planned changes, determine the procedure for their execution and fully support the procedure until we receive a decision from Roszdravnadzor.
What is included in the service
We carry out a full range of work to support VIRD:
- analysis of planned changes and assessment of the need to introduce them into the registration dossier;
- determination of the type of procedure (VIRD without examination or VIRD with examination);
- preparation and execution of a set of documents in accordance with current requirements;
- development and updating of technical and operational documentation for necessary;
- organizing additional tests if they are required to make changes;
- forming and submitting an application to Roszdravnadzor;
- supporting the examination and interaction with the expert organization;
- preparing responses to requests from experts and eliminating comments;
- monitoring the completion of the procedure before making changes to the registration dossier.
When is a VIRD required?
The need to make changes may arise in different situations. We help determine whether the VIRD procedure is required, which registration procedure is suitable for your case, and what documents need to be prepared.
Change of production site
We are assessing the impact of the new site on the registration dossier and preparing a set of documents to correctly reflect the changes.
Changing product design
We help to formalize changes in the design, configuration, materials or technical characteristics of a medical device.
Software update
We support changes to the software, including assessing the impact of updates on the safety and efficiency of the product.
Changing labeling and packaging
We update information on labeling, packaging and operating instructions taking into account current regulatory requirements.
Updating technical documentation
We check and finalize technical and operational documentation so that it corresponds to the changes made.
Expanding the scope
We help you register new indications, conditions of use or additional options for using a medical device.
Other changes to the dossier
We analyze any changes that affect the information in the registration dossier and choose the correct procedure for making them.
Result
As a result of the provision of the service, changes to the registration dossier are made in accordance with the procedure established by law, and the client receives a full set of updated documentation and support for the procedure from analysis of changes to receipt of the final decision.
