State medical device registration is a confirmation that a medical device is efficient and safe. In Russia, only registered medical devices are allowed to sell. Selling of unregistered medical devices is punished by levying fines of million rubles, deprivation of liberty of up to five years, and ban on production.
Earlier, medical device registration was a separate regulation. Today we do not use the term “medical equipment” anymore and the term “medical device” became common for all medical devices such as bandage, forceps, and automated rehabilitation systems.
Registration for the Russian market
National rules for medical device registration are valid until 2022. The market of medical devices joined the Eurasian Economic Community (EAEC) general system and is now subject to the overall control system for medical device circulation.
However, we still may register medical devices under the old rules.
The registration consists of three steps:
- Preliminary step. Medical device documentation is developed. It is necessary to undergo technical and toxicological tests. The reports must be included in the registration dossier. It is necessary to specify in the dossier the risk class and type according to the medical device Nomenclature. If you are not sure about this information, you may submit a request to Roszdravnadzor.
- Medical device registration. It is necessary to pay the state fee first and then submit registration application. If the registration dossier is correct and compliant with the regulations, we obtain the approval for a clinical trial. If something goes wrong, the authority will send its remarks. A month is given to eliminate the faults.
- Clinical trials report. We submit the report to the authority and then we obtain the marketing authorization.
The average registration period is 5 months. If your documentation is not ready yet, then it will take a month more for preparing the documents.
Registration period depends on the complexity of a medical device. It is significantly more difficult to register a medical device than a Petri dish – the amount of documentation is different and toxicological tests are not required for glassware. Medical devices may require several toxicological tests.
There are two obstacles to registering medical devices in the Russian Federation, but we know how to overcome them:
- Sometimes a new development in the sphere of medical devices is hard to classify according to Roszdravnadzor Nomenclature Classifier and OKPD2 (All-Russian classifier of products by type of economic activity). Roszdravnadzor manages each controversial case individually. We submit the documents if we have the slightest doubts because it is better to wait for a week for an answer than to revise the documents later.
- For some documents in the registration dossier there are no strict preparation rules. It is easy to prepare them but the authority may have unexpected questions. We have been exploring this issue through trial and error and now, when we have vast experience, we get remarks only in extremely complex cases.
Registration for EAEC market
A single EAEC market of medical devices has its own rules for medical device and medical equipment registration. The rules are more complicated but registration for EAEC market allows you launching your product in several countries having only one marketing authorization.
By the end of 2021 all medical devices on the Russian market must get EAEC marketing authorization. It is reasonable to register your medical device under new rules now and do not waste time for renewal later.
Choose the member state concerned and register your medical device or medical equipment in one of them. Having only one marketing authorization, you can deliver your product to other countries. It means that you do not have to register your product three times to sell it in Russia, Kazakhstan, and Armenia.
EAEC registration procedure is different:
- Approval for clinical trials is not required. You may conduct clinical trials and include the report in the dossier.
- Manufacture compliance assessment. The quality management system must meet EAEC standards. To assess manufacture compliance, team visits are arranged.
- The documents are approved in the member states as well as the written proof of state fee payment.
- Technical and operational documentation is translated into the national languages of the member states.
Since 2022, registration under EAEC rules will be the only option, so it is reasonable to start registration under the new rules right now.
There is only one problem – legislation is constantly changing. The documents are amended, new documents are published. It is important to monitor all these changes.
Use our services and you will not have to waste your time studying and monitoring EAEC legislative documents. This is part of our job.
Expert assistance in medical device registration
Medical device registration is a full range of services with our experts’ assistance.
- We thoroughly review the documents or develop documentation from scratch.
- We will submit a request to Roszdravnadzor, should there any questions arise.
- We will choose a laboratory and thoroughly study the report.
- We eliminate any faults.
- We organize an e-archive of the current dossier.
Should any problem occur, we will solve it and inform you about the progress of our work. Do not waste your time on developing and revising your documents – we will do it for you.
We can also offer a newsletter covering the latest legislation updates, market news and scientific information related to medical devices.
Trust our experience and you will obtain EAEC marketing authorization. The average employment term of our specialists is 5 years, we can handle any situation.
We constantly monitor the Russian Federation and EAEC legislation related to the circulation of medical devices, so we will correctly prepare all the documents and the registration process will be completed as soon as possible.