For legal circulation of a medical device within Russia, if any change to a device or legal entity, the registration certificate (RC) or registration dossier (RD) shall be appropriately adjusted. Perhaps, that is the only way to update medical device data in the RD on file in Roszdravnadzor. Any irrelevant information may lead to suspension and even revocation of the certificate. Of course, such a case scenario will negatively impact the reputation and finances of a company, since it is impossible to sell medical devices in this case.
The RD is amended, if something has changed in a medical device or its manufacturing process. All possible cases can be reduced to the following categories:
- Change in product characteristics
- New materials have been used for product manufacturing
- Change in GOSTs and other standards
- New designs
- Change in the product configuration
- Change of labeling
- Change in medical device structure
FCRC offers the amendment service with respect to RCs of medical devices of any purpose. Our experts will help you prepare all the necessary papers and assist at all stages of this procedure.
Types of Procedures
Introduction of amendments into the registration certificate is a process that follow different procedures:
- Simplified procedure. No examination of medical device quality.
- Complete procedure for amendments to the medical device registration dossier. To be carried out with state examination.
The simplified procedure covers changes regarding the following data:
- Information on an applicant (reorganization or change of name of a legal entity, including change of the name, location, banking details)
- Information on a medical device manufacturing site
- Information on a medical device manufacturer representative
- Name, quantity, labeling and/or package of a medical device, if the properties affecting the quality of a medical device remain stable (in this case, it is necessary to know what kind of adjustments, since state examination may be required)
- Validity periods of documents contained within the registration dossier.
A detailed list of changes covered by the simplified procedure is presented in Clause 37 of the Rules of State Registration of the Russian Federation.
The introduction of amendments into the registration documentation for a medical device is often more complicated than a new registration and requires certain knowledge and skills in preparing the RC.
FCRC’s specialists with extensive experience in amendment project management will help you understand, e.g., under what procedure adjustments must be made and how to do this as efficiently as possible.
Service Works
You provide information about the amendments to be made and the number of the medical device RC. We analyze the information received and inform you about what (full or simplified) procedure may involve the adjustments. We issue a price offer. When concluding a contract, FCRC provides full support for the project. This means we are going to be engaged with all demanding process of adjustments and registration of a medical device.
You will need:
- To provide the RC for a medical device or its number in the RZN database.
- To be open and promptly respond to the questions/requests of our specialists.
- To make timely payments for our services and state duties.
In the event of any missing device technical document, FCRC’s experts are ready to help you.
What we will do for you:
|
Simplified procedure of amendments |
Complete procedure of amendments |
|
Works |
|
|
|
|
Service execution time |
|
|
1-3 months |
6-9 months |
Documents required for RD Amendments
The following package of documentation should be submitted to Roszdravnadzor for the successful completion of this procedure:
- Application
- Confirmation of state duty payment
- New RD as amended.
We will help you collect all the necessary documents.
Amount of State Duties
|
Risk class |
Amount by risk class, as paid in case of safety and quality examination |
State duty amount |
|
1 |
Low-risk medical devices |
32 000 RUB |
|
2а |
Medium-risk medical devices |
48 000 RUB |
|
2б |
Higher-risk medical devices |
64 000 RUB |
|
3 |
High-risk medical devices |
104 000 RUB |
|
|
Issue of registration certificate (RC) |
2 500 RUB |
The final cost of the service is subject to the need for state examination and the volume of documentation to be prepared and the medical device type. For an accurate calculation of the cost of work, please, contact us.
Please, note that the state duty is paid by an applicant directly to Roszdravnadzor.
Our Advantages
You should start cooperating with us for the following reasons:
- Professionalism. A team of qualified specialists is at your service.
- Real assistance. We assist you in finding solutions in a challenging situation.
- Guarantee. We provide services within the agreed timeline.
- Benefit. We set transparent and affordable prices for our services.
- Result. We have a high (97.8%) result of positive registrations.
We know everything about how to amend RD and RC correctly and the specifics of such a procedure. We are ready to help you register your device, send your application to info@fcrc.consulting or call us at +7 (495) 374-00-19. For a detailed calculation of the timing and cost of the service for amendments to the registration dossier, provide us with the description, technical or operational documentation.