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.
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
– 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
staff experts
years on the market
months for registration on average
Feedback
During our cooperation, the company MedRegExpert, Ltd. has proven to be a professional company with highly qualified staff. They solve all the tasks in an efficient and timely manner. We highly recommend MedRegExpert, Ltd. as a reliable company in the sphere of medical device registration.
Med-Dent, Ltd.
The staff of MedRegExpert, Ltd. have proven to be professional. We should mention the high quality of their work. They successfully managed all the objections of Roszdravnadzor. The goal was achieved. Our company recommends MedRegExpert as a reliable partner with a professional team of experts.
InstrMed, Ltd.
The company MedRegExpert, Ltd. has demonstrated its ability to responsibly manage the tasks and perform the work with high quality and in a timely manner. Professionalism, organization of staff, and a team spirit is what sets the company apart from the competitors. All the tasks were successfully finished.
Tekhstomkom, Ltd.
The main characteristic of MedRegExpert, Ltd. is a high level of organization of staff and their efficiency, willingness to quickly respond to the change of circumstances. PAKS-trade, Ltd. would like to note a high potential of MedRegExpert, Ltd. and their focus on further development.
PAKS-trade, Ltd.
Registration of medical devices in full compliance with EAEC rules
Call us now for a consultation
Our Staff
Alla Sharonova
CEO
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
News
WE ARE CONSTANTLY MONITORING THE CHANGES
New regulations for the inspection of pharmaceutical manufacturers
The Ministry of Industry and Trade is preparing a regulation for inspecting drug manufacturers. The production facilities
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
Our contacts
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,
Moscow, Leninskaya Sloboda 19, of. 4064
The procedure for registration and examination of medical products
Итог
Getting a registration certificate