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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 | 82 次浏览 | 分享到:
欧亚经济联盟框架内医疗产品注册
欧亚经济联盟框架内医疗器械流通的监管是根据2014年5月29日欧亚经济联盟条约,欧亚经济联盟框架内关于医疗器械(医疗器械和医疗设备)流通的共同规则协议进行的,2014年12月23日国际电联法的其他国际条约,委员会的决定以及成员国的立法。
欧亚经济联盟框架内的医疗器械注册按照欧亚经济委员会2016年2月12日第46号决定批准质量和有效性的登记和审查规则进行。
http://www.roszdravnadzor.ru/medproducts/registrationEAEU
医疗器械的国家注册是确认产品符合所有法规和安全标准并可用于俄罗斯市场的认可过程。患者的生命和健康取决于医疗产品的质量。因此,只有那些使用达到其使用风险的产品才能在市场上销售。实施未经注册的医疗器械将被处以数百万美元的罚款,最多五年的监禁和生产禁令。

2018年开始俄罗斯的医疗产品市场被纳入欧亚经济联盟(EAEU)的总体系统。从这一刻起,可以向EAEU的成员国家提供医疗产品只需要提供一份医疗器械注册证书就可以了,不需要每个国家单独注册,浪费大量的时间和金钱。但欧亚联盟EAEU注册需要进行新的注册程序。到2022年它将是唯一的一个适用于医疗器械注册的法规。有关EAEU立法的工作仍在继续,一些文件仍在制定中。因此,制造商通过咨询机构注册医疗产品。这消除了监视新文档并解决移动中出现的问题的需要。
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)

欧亚联盟注册登记程序与现有医疗器械注册的关键不同点:
1、临床试验无需特殊许可。他们立即通过,他们已经提交了临床结论文件。
2、不仅要检查产品,还要检查工厂。该特别委员会检查工厂的质量管理体系是否符合EAEU的国际标准。
3、所有文件在成员的国家都是一致的。也需要支付国家注册费用。
4、技术和操作文件需要被翻译成每个成员国家的国家语言。
5、在我们工作的专家仅在去年才开始研究一般注册。预测没有严格形式的对文件的可能评论是困难的。唯一的办法是:监测每个新的欧洲经委会文件和国家部门的解释。为了不浪费时间和精力,请向专业人员提供您的产品注册。
 


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.