Registration of medical devices
in Russian Federation and EAEU countries

Registration of medical devices in Russian Federation and EAEU countries

Preparation of documents for medical devices registration according to the regulation requirements;

Amendments to the registration dossier (registration certificate)

Changes assessment, development of documents and clarifying letters from a manufacturer to execute a dossier update procedure.

Local tests & trials

Organization and coordination of all required local tests/trials (toxicological, technical, EMS, approving the type of measuring tools, clinical trials).

Licensing of medical devices manufacturing and maintenance

Documents preparation and support at all stages of licensing procedure.

Medical devices certification

Interaction with certification authorities.

Consulting

At all stages of provided services.

About us

Our company provides services for medical devices registration for their subsequent admission for circulation in Russian Federation and EAEU countries, as well as services for dossier update, support in medical devices certification, assistance in licensing of medical devices maintenance and production.

We understand the importance of each project and we take a responsible approach to the proposed services execution, ensure compliance with regulations and interpretations of regulatory authorities and provide solutions for varying complexity tasks.

We know what difficulties customers face modifying a product after its registration, so we try to minimize the need for constant registration dossier update and thus ensure its long-term compliance with the delivered product.

Not only timely receipt of the registration certificate is our goal, but also high quality of the submitted dossier.

We do care about our customers and offer the best solutions for each specific case. It is really important for us to maximize benefits for our customer.

Consultation

Ask a question about the company’s services or send a request for a commercial offer.

We support our clients during all stages of the process:

Documents expertise
Obtaining a registration
certificate;
Cancellation of a medical device
state registration;
Documents translation
and notarization;
Assessment of potential changes for a dossier and their impact;
Receipt of a registration certificate duplicate;
Preparation of documents for obtaining permission to import samples of medical devices for further registration purposes;
Registration dossier preparation and submitting to Health Authority;
Participation as a representative for Health Authority reviews

Do you have
any more questions?

Call +7 (495) 204-19-60 or leave a request
and we will contact you.

Consultation

Ask a specialist a question

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