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Have you got any questions about registering a medical device? We have got answers.


Are you wasting your time for registration?

Let the professionals register your medical device. We will optimize time and costs for medical device registration.

 

Are you still not participating in tenders?

Our aim is to take your product to the market as soon as possible. Get your marketing authorization in no time.

Has your MAA been rejected because of laboratory errors?

We thoroughly check compliance of all documents before sending them to Roszdravnadzor (Federal Service for Surveillance in Healthcare). We provide indemnity insurance that covers the amount of the state fee!

Do you have to pay the entire amount?

We accept monthly payments. Plan your monthly budget for registration and do not overpay.

Please, note:

Since 2017, a medical device can be registered in several EAEC countries and it is allowed to provide only one marketing authorization. This new registration procedure is in compliance with the Agreement On the Uniform Principles and Rules Governing Market Circulation of Medical Devices within the Eurasian Economic Union as of December 23, 2014.

All medical devices should be registered according to new rules by December 31, 2021.
Medical device registration by new rules is easy. The main thing is to react in due time to new requirements. We constantly monitor the changes and will register your medical device quickly in full compliance with the EAEC rules at an affordable price.

 

APPLY FOR THE CONSULTATION

RF Code of Administrative Offenses:

  • Article 6.28. Violation of established rules concerning the circulation of medical devices
  • Article 6.33. Circulation of falsified, counterfeit, substandard and non-registered medicines, medical devices and biologically active substances.

The Criminal Code of the Russian Federation:

  • Article 235.1. Illegal production of medicines and medical devices./span>
  • Article 238.1. Circulation of falsified, counterfeit, substandard and non-registered medicines, medical devices and biologically active substances.
  • Article 327.2. Forgery of documents on medicines or medicinal devices or the packaging of medicines or medical devices.

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Our Services


MedRegExpert

Marketing authorization for your medical device in compliance with RF or EAEC procedure quickly and at a reasonable price.

— 100% compliance with deadlines
— Monthly payments

Apply for the consultation
– Medical device registration
– Documentation
– Consultations
– Amendments to the master file

We register medical devices in full compliance with EAEC rules

 

We provide consultations in any matter regarding state registration

Organization of electronic archive

THE LIST OF ALL SERVICES
14

staff experts

5

years on the market

8

months for registration on average

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Registration of medical devices in full compliance with EAEC rules

Call us now for a consultation
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Our Staff


Sergey Karnaukhov

CEO

Sergei Karnaukhov
EXECUTIVE DIRECTOR
Among my employees are highly competent specialists in the sphere of medical device registration in the territory of the Russian Federation

Statistics
Roszdravnadzor has performed 5 thousand inspections of manufacturers and vendors of medical devices during 2016.


• 3.5 thousand of non-conformance reports were issued (67% of the number of inspections)
• 2 thousand criminal cases were opened
• the total amount of fines was 25 million rubles

• 337 non-registered medical devices
• 135 substandard medical devices
• 15 were withdrawn from circulation
• 20 cases of falsification
• 3 million medical devices did not meet the safety and quality standards

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We inform you about any changes in the legislation related to state registration and share the news on the medical device market.

Our contacts


Email

zapros@medregexpert.ru

Contact phone numbers

+7 800 505-234-7

Mon — Thu 9 a.m.-6 p.m Fri 9 a.m.-5 p.m..

Address

LLC MedRegExpert,

Russia, Moscow, st. Kozhevnicheskaya 7, p. 1




The procedure for registration and examination of medical products

Итог

Getting a registration certificate

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