Registration of medical devices • Медрелис
Registration of medical devices

Registration of medical devices

Registration of medical devices is a prerequisite for their importation to, use, sale, and manufacturing in the Russian Federation.

State registration is mandatory for all medical instruments, apparatus, devices, equipment, materials and other medical products.

How we arrange for registration of medical devices
We define an overall goal
It is very important to define how your medical device will be registered, how you intend to import and distribute it, how you are going to deliver it to medical facilities, and whether you are going to take part in tenders. We will help you solve these and many other issues in order to define a clear way we will follow together
We prepare an application for registration
We identify the product composition, accessories, the number of design modifications, and classification codes. A properly completed application largely determines the future success in the registration process
We complete the documents for importation of the medical device to the Russian Federation
For foreign-made medical devices, we prepare all documents necessary to obtain an import permit from the Federal Service for Surveillance in Healthcare (Roszdravnadzor)
We collect a package of documents
Each registration case is unique in its own way. We will help you to correctly set links between the developer, manufacturer and production sites. We provide documentary evidence of the quality, performance and safety of medical devices. An appropriate set of document is a reliable evidence for any registration
We prepare technical, operational and regulatory documentation
We know what Roszdravnadzor pays attention to. Therefore we develop or adapt the documentation for medical devices to make sure it is accepted without objections
We carry out all necessary testing
We select laboratories that can conduct, properly document and present the testing results specifically for your medical device based on its specific characteristics and features. We oversee the testing process and examine the results to make sure they meet the registration purposes
We support your case with Roszdravnadzor
Disputes that sometimes may arise during the registration of medical devices require a competent response, such as to resolve objections or appeal against wrongful expert decisions. We can solve these issues in a professional manner
We register medical devices according to the new regulations
We have been registering medical devices since 2004. During this time, we have become stronger in dealing with changes in registration regulations and have gained much useful knowledge and experience
WORKING WITH US,
YOU WILL GET
GUARANTEES
We have been delivering on our promises for more than 10 years and we value our reputation
COMFORT
Our work is challenging, multifaceted and stressful. We take care of all challenges — you get the result
INTEGRITY
We do not charge extra fees for testing. The prices for all services are fixed and not subject to change after the contract is signed
SPEED
Our quality management system allows for prompt delivery
FAQ
How long does it take to obtain registration for a medical device?
Risk Class I: 6 to 8 months
Risk Class II and III: 9 to 12 months

The timing of registration may vary depending on many factors, such as the complexity of the medical device, completeness and quality of information about the medical device, how prompt the manufacturer is in providing any missing data for the medical device, etc.

The duration of the registration process may be shortened. Please contact us for a detailed review of the documentation for your medical device.
What is the procedure for paying the registration fee for medical devices?

The cost of registration is fixed and depends on the risk class and the number of modifications of your medical device. We divide the fee into 12 equal parts payable on a monthly basis.

We arrange for your direct contracts with all the parties involved (laboratories, testing centres), so that all payments are transparent.
Are your partner laboratories reliable?
We work only with proven laboratories, whose reports are accepted by Roszdravnadzor. Our extensive and successful experience of cooperation with them has given us a sustainable understanding of who is best to engage for technical, toxicological and clinical trials of medical devices based on their specific features.

Our specialists always thoroughly check the test reports before they are approved, so the probability of errors is minimal.
What is required for the registration process?
  1. Provide us with necessary documents to prepare a master file for your medical device
  2. Inform us of your preferences as to importing and distributing your medical device, whether you are going to take part in tenders, etc.
  3. Promptly provide any missing information about your medical device during the registration process
  4. Sign all documents required for the registration of medical devices, such as contracts, powers of attorney, and letters.

We are trusted

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and more than 20 clients

Customer testimonials

Thank you for your help in obtaining a Registration Certificate for our medical devices Pixel and Avery hearing aids. All registration related work has been performed quickly and professionally. The clinical assessment completed by your staff has saved us time, and the prices for your services are reasonable and reflect the value you deliver.
Maxim V. Murzinov
General Director, Aurika LLC http://www.aurica.ru
Thank you for your help in obtaining a Registration Certificate from Roszdravnadzor for laryngeal mask airways (LMA). High professionalism and competence of your staff invariably cause respect in our hearts. We consider the combination of timing and pricing offered by you one of the best in this market.
Vladislav Y. Chernyshev
General Director, REAN LLC https://reanmed.ru
We would like to express our sincere gratitude for the fruitful cooperation and high quality service in the preparation and conduct of clinical trials for the medical device ENDOCAB endoscope drying and storage cabinet. You have saved us time and helped us achieve the desired outcome.
Denis D. Pozen
General Director, Bandeq-MS LLC http://www.bandeq.ru
We would like to thank your management and employees for their competence and ability to solve complex, integrated tasks with testing laboratories, the Federal Service for Surveillance in Healthcare and clinical sites. We hope for further mutually beneficial cooperation.
Alexey V. Mazanov
General Director, PTK Belva LLC http://www.belva.ru
Thank you for your high quality work in registration and amendment of registration certificates for products of Lojer Oy, Finland. We have been successfully working with MEDRELIC LLC and its staff for many years and undoubtedly recommend them as a trusted and proven partner.
Viktor Y. Samsonov
General Director, Lojer Medical LLC http://www.lojer-medical.ru
All work in preparation of documents for registration has been performed quickly and professionally. Your services have saved us much time, and your pricing is reasonable and reflects the value you deliver. We will be happy to work with you again.
Alexander I. Nikolayenko
General Director, NDA Business Medical Company LLC http://www.nda.ru
The services to support our registration projects have been provided with high quality and professionally. We would like to particularly mention the willingness and ability of your staff to resolve challenging situations with testing laboratories and clinical sites, as well as transparency and timeliness of communications.
Vitaly Khaindrava
Registration Manager for Russia http://dentsplycis.com

Submit request

Medrelic Контакты +7 495 785-72-85 info@medrelic.ru
109074, Moscow 2/5/4 Slavyanskaya square, build. 3
Contacts
+7 (495) 785-72-85
+7 (495) 785-72-84

info@medrelic.ru
Moscow, 109074
2/5/4 Slavyanskaya square, build. 3,
office 4057
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