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欧亚联盟医疗器械注册最新进展Medical equipment in the EAEU,Медицинское оборудование в ЕАЭС
来源: | 作者:pmta78c0f | 发布时间: 2018-10-18 | 706 次浏览 | 分享到:

俄罗斯医疗器械注册/海关联盟医疗器械注册(欧亚联盟 2021年实施)


Registration of medical products
HomeRegistration of Medical Products
The state registration of medical devices is a confirmation that a medical product (EMI) is effective and safe. In Russia, it is possible to sell only a registered medical device. Sale of unregistered medical products is punishable by millions in fines, imprisonment of up to five years and a ban on production.

Registration of medical equipment used to be a separate regulation. Now the concept of "medical equipment" is out of use, and the term "medical device" has become common to all medical devices: bandages, clamps and automatic rehabilitation systems.

Registration for the Russian market

National rules for registration of medical devices and equipment are valid until 2022. The market of medical products has joined the general system of the Eurasian Economic Union (EAEU) and goes under the general system of monitoring the circulation of medical products.

But it is still possible to register medical devices and medical equipment according to the old rules.

Registration takes place in three stages:

Preparatory stage. We develop documentation for the medical device. It will be necessary to pass technical and toxicological tests, the conclusions should be in the registration dossier. The dossier should indicate the risk class and type according to the Nomenclature Classifier. If in doubt, we write a request to Roszdravnadzor.
Begin registration of medical device. We pay the state duty and apply for registration. If there are no questions to the registration dossier, we get permission for clinical trials. If something is wrong, the agency will send comments. They need to be eliminated in a month.
Examination of the findings of clinical trials. We pass the conclusion of the clinical trials to the Office. After the examination we get a registration certificate.
The average registration period is 5 months. Mortgage another month if you do not have the documentation: that is how much we need to develop it.

At the time of registration affects the complexity of the product. It is more difficult to register medical equipment than a Petri dish: a different volume of documentation, and no toxicological tests are needed for laboratory glassware. And for medical technology may need some toxicological expertise.

In the process of registration of medical devices in the Russian Federation there are two difficulties. And we can deal with them:

New development in medical technology is sometimes difficult to bring under the nomenclature classifier of Roszdravnadzor and JECD2. And every controversial situation Roszdravnadzor decides individually. We submit a request to the Office, if we have doubts. It is better to wait a week for a response than to correct documents a month.
Some documents of the registration dossier are not strict. It is convenient to make them, but the department has unexpected questions. We understood this through trial and error, and we receive comments only in particularly difficult cases.
Registration for the EAEU market

The single market of the EAEU medical products implies its own rules for registration of medical devices and medical equipment. It is more complicated, but it will allow you to ship your product to several countries with one registration certificate.

Until the end of 2021, all medical devices in the Russian market must receive a registration certificate of the EAEU sample. It makes sense to immediately register the medical device under the new rules and not to waste time on re-registration.

Select countries of recognition, register medical devices or medical equipment in one of them. And you can deliver the product in all, one RU. You do not need to register the product three times to sell it in Russia, Kazakhstan and Armenia.

Registration according to the rules of the EAEU differs from the national one:

Do not need permission for clinical trials. They are carried out immediately, and the conclusion is included in the dossier.
Check the production. The quality management system at work must meet the standards of the EAEU. To do this, organize a visiting commission.
All documents are consistent in the countries of recognition. Notice of payment of state duty, too.
Technical and operational documentation is translated into the national languages of the countries of recognition.
Since 2022, registration according to the rules of the EAEU will be the only one worth starting now. This is a rewarding experience.

Difficulty is one: legislation continues. Correct accepted documents and publish new ones. For this you need to constantly monitor.

Use our services, you do not have to monitor the legislation of the EAEU, and for us it is part of the work.

Expert support for registration of medical devices

Registration of medical products is a complex of services for the full maintenance of your product.

Check the documentation or develop from scratch
We will write a request to Roszdravravnadzor on all issues
We select laboratories and subtract conclusions
We will work out observations of Roszdravnadzor
We will collect the electronic archive of the current dossier
We ourselves will offer a solution to each problem and report on each stage of work. Do not waste time on the development and correction of documentation - we will do it for you.

We also keep an informational bulletin on the latest developments in legislation, market and science in the field of medical devices.