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Создан: 31.08.2020
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Registration of medical devices within the EAEU

Понедельник, 31 Августа 2020 г. 11:19 + в цитатник

Since January 1, 2015, Russia is a member of the Eurasian Economic Union (EAEU), whose member states, at the present time, will also be the Republic of Armenia (because 2015), the Republic of Belarus (since 2015), the Republic of Kazakhstan (because 2015 g.) and the Kyrgyz Republic (since 2015). The main advantage for manufacturers of medical devices in belonging to the EAEU is a single enrollment (in some of the EAEU member states) and the following possibility of promoting their goods as medical from the EAEU recognition countries.

Engineering Center Medical Products and Equipment

Registration of medical devices within the EAEU has completed per the Rules for Registration and Knowledge of the Safety, Quality, and Effectiveness of Medical Devices, approved by the Decision of the EAEU Council dated February 12, 2016 No. 46. Currently, and before December 31, 2021, a transitional period lasts, permitting manufacturers of medical devices to prepare for the upcoming changes and issue registration certificates for their goods (existing RU, such as ones that are nearing, will expire on December 31, 2021).

These are the files needed for foreign manufacturers: a lawyer's records such as medical device approvals (if any) and also a power of attorney for a licensed representative of the Russian Federation's producer. The document on the company's registration as a legal entity (from the nation of production); Manufacturer's certificates of conformity (if any), files confirm proper production requirements and technical file (if available) and instruction or operating manual (if any). And, a description of the item being registered and photographs of the product that is registered. To obtain further information kindly look at медицинские изделия

Engineering Center Medical Products and Equipment

Therefore, whenever folks want help, they can get in contact with the experts at the company.Clients can follow the simple instructions and hand in the essential documents. They could take a look at the website where details of these very important documents are supplied. Once they submit these, they only have to wait a while before they receive the registration. With the certificate accessible, nobody can prevent them from entering the market and conduct legal business.


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