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REGISTRATION IN CIS AND EUROPE

Home | REGISTRATION IN CIS AND EUROPE

REGISTRATION OF MEDICAL DEVICES

Our company offers services for the registration and certification of medical products in the CIS countries and Europe.

We provide assistance at all stages - from collection to submission of documents. It will take at least 5 months to register a medical device, the terms may vary depending on the complexity and specifics of your project. Our specialists examine the submitted documents, advise on emerging issues and accompany the entire registration procedure.

What kind of medical devices
can be registered?

Instruments

Apparatus

Devices

Equipment

Furniture

Materials

Other items used for medical purposes

Why is it worth contacting us?

Preparation of documentation package

Expert preparation of documentation for submission to Roszdravnadzor is the key to obtaining the Registration Certificate. We work with all regions of Russia!

Maintenance of the registration dossier

All work on maintaining documentation, testing and examination is performed within the terms stipulated by the contract. We approach the process by putting ourselves in the place of experts in Roszdravnadzor, we take into consideration all possible nuances!

Direct contact with Roszdravnadzor

We are not intermediaries, and we do not transfer your cases to third parties, your case is guaranteed to have all the necessary and correctly executed documents for the successful obtainment of the Registration Certificate.

Our services

Examination and analysis of the provided documents

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Preparation of documentation package for clinical trials (research support)

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Preparation of documentation package for technical and toxicological tests (test support)

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Consultation on the development of technical and operational documentation based on the data provided by the manufacturer, in accordance with the requirements of regulatory documents

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Determination of the type of medical product in accordance with the nomenclature classification

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Determining the class of potential risk of using a medical device in accordance with the nomenclature classification

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Assessment of documentation package completeness and correctness of paperwork for passing the procedure of state registration of medical devices

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Initial assessment of the purpose of a medical device

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Determination of the code of the All-Russian classifier of products for a medical device

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Preparation and submission of documentation package for the state registration, approval of the application, tracking the stages of registration (registration process support)

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What documents are required to register a medical device?

Medical products registration of domestic production

• Notarized TIN

• Notarized OGRN

• Statement from the Unified State Register of Legal Entities

• Description of the product, its characteristics, purpose and intended scope

Medical products registration of foreign production

• Notarized TIN

• Notarized OGRN

• Statement from the Unified State Register of Legal Entities

• Technical file part A