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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.

Registration by the rules

For more than 5 years we have been making the process of state registration of medical devices and medicines understandable, predictable and safe for our clients. To do this, we carefully study each registration and look for ways to make our service even more convenient.

APPLY FOR THE CONSULTATION

Working in the open

  • We provide each client with access to the project on the MedRegExpert corporate portal. Track registration progress, exchange documents, communicate with an expert and get the latest news on your project in one place.

Easy checkout

  • Pay for the work monthly or in stages, the final cost will not change. If these options are not entirely convenient for you, the manager will help you choose a personal payment plan.

Don’t forget anything

  • We have digitized and automated all the routine processes. Now we can completely immerse ourselves in work without fear of missing out on something important. The system will prepare the information itself, send it for verification and remind everyone of urgent matters. Including clients.

REQUEST A PHONE CALL

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
– Registration of a medical device

We register products of any risk class, medical equipment and even software. We conduct registration from the development of documents to obtaining a registration certificate.

– Registration of medicines

We will select analogues ourselves, find a laboratory and control clinical trials. You will only need to provide us with information on time

– 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

Feedback


Registration of medical devices in full compliance with EAEC rules

Call us now for a consultation
REQUEST A PHONE CALL

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

Olga Soldatenko


Olga Soldatenko
EXPERT DIRECTOR

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

Request a call

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

Download scheme