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Amendments to the registration dossier/certificate for a medical device

Amendments to the registration dossier/certificate for a medical device

To ensure the legal circulation of a medical device within the Russian Federation, any changes to the product’s characteristics or information about the legal entity must be promptly amended to the registration certificate (RC) and/or registration dossier (RD).

More details

Amendments to the registration dossier (RD) are required in the event of modifications to the characteristics of a medical device or changes in the technological process of its manufacture.

The most common reasons for updating the RD include:
Adjustment of technical characteristics of the product;
Application of new materials in
the production process;
Updating standards;
Adding new design options;
Change in overall dimensions or weight characteristics;
Revision of design or content of
marking;
Modification of product design.
Depending on the nature of the changes, the procedure for amending the registration documentation (VIRD) can be of two types:
Changes that do not require an examination of the quality, effectiveness and safety of the medical device

This procedure is simpler and faster.

Change of validity periods of documents contained in the registration dossier;
Changes in information about the manufacturer (producer)
 of a medical device (reorganization or change of name
 of a legal entity, including a company name, change
 of address, change of details);
Change of information about the Authorized Representative of the manufacturer (reorganization or change of name of a
legal entity, including a company name, change of address, change of details);
Change of the name of a medical product in terms of the trademark and other means of individualization;
Exclusion of information about the model (brand) of a medical device from the registry entry;
Changing the labeling design without changing the symbols used in labeling the medical device; If new symbols are added to the label, a change procedure with expert review is required;
Change of classifier code.
Changes requiring an examination of the quality, effectiveness and safety of the medical device.

These are changes related to the quality, efficacy, and safety
of the medical device itself, as well as changes or confirmation
of its characteristics. Typically, such changes must be
confirmed by testing in accredited laboratories.

Our team will provide full support during the change process:

Confirm the type of changes to be made
Depending on the type of VIRD, we will take the following steps:
Simplified procedure for making changes
Complete procedure for making changes
Need a consultation?

Request a free consultation on the registration procedure 
and ask all your questions.

Reasons to choose our team:

Transparent planning

We develop a detailed
registration plan in
collaboration with the
manufacturer or authorized representative… More

Professional approach

Our staff includes experts with proven experience in the field of medical device registration;

Flexible cooperation
format

We provide both full turnkey
support and individual stages
of the registration process;

Optimal plan

We evaluate the need and type of changes, and help create an optimal plan for making changes, taking into account upcoming adjustments to the MI by the manufacturer;

Dialogue with the regulator

We engage in dialogue with the regulator and help find solutions
in difficult situations.

Transparent planning

We develop a detailed registration plan in
collaboration with the manufacturer or authorized representative… More

Professional approach

Our staff includes experts with proven experience in the field of medical device registration;

Flexible cooperation format

We provide both full turnkey
support and individual stages
of the registration process;

Optimal plan

We evaluate the need and type of changes, and help create an optimal plan for making changes, taking into account upcoming adjustments to the MI by the manufacturer;

Dialogue with the regulator

We engage in dialogue with the regulator and help find solutions
in difficult situations.

State oversight is becoming stricter every year. During RZN inspections in hospitals, the actual medical device is compared with the data in the registration dossier.

If discrepancies are identified, and the manufacturer has not updated the information in the registration documents, the product may be deemed substandard, unsafe, and, in some cases, unregistered.

This may lead to the suspension of the registration certificate. Information about inspections is published in open sources and may damage the company’s reputation and impact its finances.

1. We clarify the scope of necessary tests, the number of required samples and documents from the manufacturer;

2. We import samples to Russia;

3. We prepare documents and relevant amendments to the registration dossier materials;

4. We organize and supervise the testing process;

5. We coordinate all amendments with the manufacturer/UPP;

6. We submit a set of documents to the Federal Service for Surveillance in Healthcare;

7. We promptly address any potential expert comments;

8. We notify you when the process of making changes is completed; the changes will be reflected in the Unified Register of Legal Entities.

1. We clarify the scope of documents required from the manufacturer and help with templates;

2. We prepare documents and relevant amendments to the registration dossier materials;

3. We coordinate all amendments with the manufacturer/UPP ;

4. We submit a set of documents to the Federal Service for Surveillance in Healthcare;

5. We promptly address any potential expert comments;

6. We notify you when the process of making changes is completed; the changes will be reflected in the Unified Register of Legal Entities.

We develop a detailed registration plan in collaboration with the manufacturer or authorized representative and provide timely information on potential risks and necessary actions to ensure compliance with the schedule;

Request for consultation

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