At a glance:
Medical Devices Registration
in Russia
Medical Devices Registration
in Russia
Everything you need to know entering Russian dental market
INTRODUCTION
State registration of medical devices in the Russian Federation
This process, as throughout the world, is bureaucratic and slow, requiring a large amount of documentation, samples, testing, and for high-risk medical devices, production inspection. However...
We will help you walk this path easier, faster with us!
We have been working with regulatory documentation for medical products for 20 years and our experience and knowledge will help us with this!
Our employees have experience in successfully obtaining registration certificates for medical products, certificates of cosmetic products, dietary supplements. Our partners will help with drug registration. And our prices are the best on the market. Plus, we value our reputation and guarantee that you will complete the process!
Relying on our negotiation experience, below we will answer frequently asked questions from our clients.
Our employees have experience in successfully obtaining registration certificates for medical products, certificates of cosmetic products, dietary supplements. Our partners will help with drug registration. And our prices are the best on the market. Plus, we value our reputation and guarantee that you will complete the process!
Relying on our negotiation experience, below we will answer frequently asked questions from our clients.
Authorized representative in Russia
What do you need to know to start the registration process?
1. The process is carried out in accordance with Decree 1416
2. It is necessary to have an authorized representative in the Russian Federation. A company that will sell your products in the Russian Federation and takes responsibility for the circulation of medical devices.
+ while you are negotiating and looking for a partner company, we are ready to start the process and prepare your dossier: preparation of technical documentation, organization of technical, toxicological, clinical trials!
You will speed up the process by 4-5 months, and during this time you will find your partner!
1. The process is carried out in accordance with Decree 1416
2. It is necessary to have an authorized representative in the Russian Federation. A company that will sell your products in the Russian Federation and takes responsibility for the circulation of medical devices.
+ while you are negotiating and looking for a partner company, we are ready to start the process and prepare your dossier: preparation of technical documentation, organization of technical, toxicological, clinical trials!
You will speed up the process by 4-5 months, and during this time you will find your partner!
Deadlines for obtaining a registration certificate
Time matters
How to get Registration Certificate faster?
Our experts will help with the preparation and execution of documentation.
We work strictly, complying with the law. Without intermediaries, we resolve complex and controversial issues directly with Roszdravnadzor.
We have reliable partners - testing laboratories that have all the necessary state licenses and permits.
This makes it possible to prepare a dossier and undergo expert confirmation faster and with high quality!
+ By providing us with the requested information and samples on time and promptly, we focus on a year of collaboration with you!
How to get Registration Certificate faster?
Our experts will help with the preparation and execution of documentation.
We work strictly, complying with the law. Without intermediaries, we resolve complex and controversial issues directly with Roszdravnadzor.
We have reliable partners - testing laboratories that have all the necessary state licenses and permits.
This makes it possible to prepare a dossier and undergo expert confirmation faster and with high quality!
+ By providing us with the requested information and samples on time and promptly, we focus on a year of collaboration with you!
How to optimize the cost of registration?
Registration costs include:
-payment for translation, notarization, our services
-organization of technical, toxicological, clinical tests required by Decree 1416 on registration of medical devices in the Russian Federation
- payment of state duty.
+ payment takes place in stages during the preparation of the dossier and you pay for part of our services only after receiving the registration certificate!
+ our specialists will study your products in as much detail as possible and will offer a more economical option allowed by our legislation.
+ we value our clients and reputation! And we are interested in returning to our consultation with new products - therefore we offer favorable conditions for our services!
Today, the cost varies from 2-3 million RUR. It depends on the product and design options.
-payment for translation, notarization, our services
-organization of technical, toxicological, clinical tests required by Decree 1416 on registration of medical devices in the Russian Federation
- payment of state duty.
+ payment takes place in stages during the preparation of the dossier and you pay for part of our services only after receiving the registration certificate!
+ our specialists will study your products in as much detail as possible and will offer a more economical option allowed by our legislation.
+ we value our clients and reputation! And we are interested in returning to our consultation with new products - therefore we offer favorable conditions for our services!
Today, the cost varies from 2-3 million RUR. It depends on the product and design options.
Stability
How to choose a distributor and properly design the Registration certificate?
You may have several distributors in Russia. But when receiving a registration certificate, in accordance with the legislation of the Russian Federation, you need to declare one company as an authorized representative in the Russian Federation. The data of this legal entity will be entered into the register of Roszdravnadzor, and, in case of any questions regarding the circulation of this medical product, representatives of the Service will contact this company. For any complaints or unfair treatment on the territory of the Russian Federation. Therefore, this company bears responsibility for product circulation, and data is included in the instructions for use and on the label to inform citizens of the Russian Federation.
When changing your authorized representative, you can make changes to your dossier. It is necessary to have the original registration certificate.
You can register a ru in your name, the manufacturer, or in the name of an authorized representative.
In any case, the manufacturer company has the rights to the registration certificate.
You may have several distributors in Russia. But when receiving a registration certificate, in accordance with the legislation of the Russian Federation, you need to declare one company as an authorized representative in the Russian Federation. The data of this legal entity will be entered into the register of Roszdravnadzor, and, in case of any questions regarding the circulation of this medical product, representatives of the Service will contact this company. For any complaints or unfair treatment on the territory of the Russian Federation. Therefore, this company bears responsibility for product circulation, and data is included in the instructions for use and on the label to inform citizens of the Russian Federation.
When changing your authorized representative, you can make changes to your dossier. It is necessary to have the original registration certificate.
You can register a ru in your name, the manufacturer, or in the name of an authorized representative.
In any case, the manufacturer company has the rights to the registration certificate.
Documentation
Basic documents required for the registration process:
- ISO 13485 certificate. If you have a simple non-sterile product of risk class 1, you can provide internal certificates of production confirmation.
- EU certificate - if available. Its absence does not prohibit you from undergoing the quality confirmation procedure in the Russian Federation.
- ower of attorney for an authorized representative in the Russian Federation
- Technical file (you and I prepare it together, in accordance with our legal requirements)
- Instructions for use (you and I prepare it together, in accordance with our legal requirements)
- Clinical report, if there is an article on the use of the product in your country, post-marketing report.
- And the product samples of course!
Reliability
How to choose a registration consultant?
The registration service is offered by many companies and private applicants. However:
-legislation is constantly updated on the registration procedure and it is very important to have experience in obtaining certificates in various laws
-the company always has several employees, and, if necessary, employees will replace each other and the process will not stop
-education of employees and reputation of the company affect the time and cost of obtaining a registration certificate
These advantages are in our consultation!
Send your questions to us by email, we will consider and give you our suggestions!
The registration service is offered by many companies and private applicants. However:
-legislation is constantly updated on the registration procedure and it is very important to have experience in obtaining certificates in various laws
-the company always has several employees, and, if necessary, employees will replace each other and the process will not stop
-education of employees and reputation of the company affect the time and cost of obtaining a registration certificate
These advantages are in our consultation!
Send your questions to us by email, we will consider and give you our suggestions!
Registration certificate in the EAEU two options There are two procedures for obtaining registration possible: - National quality confirmation (registration certificate is valid on the territory of the Russian Federation) - Confirmation for EAEU countries. However! This procedure is still at the stage of design, development and agreement between countries. Work to optimize legislation is actively underway; we expect changes no earlier than the summer of 2025. Now, going through this procedure is long and expensive, since there are many types of medical devices, the classifier includes a range of thousands of items, and the requirements for the quality of the production site differ between the EAEU countries. There is no single list of harmonized standards. Thus, the harmonization of legislation today makes it difficult to obtain a certificate. - Our legislation also provides for an accelerated procedure within the framework of national confirmation. But! The certificate is issued only for a batch of goods and quantity, for certain types of products, and the registration certificate has a limited validity period (until 2025). + Thus, we advise obtaining a national marketing authorization within a given period of time. It is valid for an indefinite period and you can work throughout the Russian Federation. And we will be happy to help you with this! |
Contacts
Helena Gromova
Director of Product Registration Projects
registr@dental-consult.org