Development of Registration Dossier

The utilization of medical products on the market is strictly controlled by supervisory authorities of our country and availability of permits is the basic premise for sales of the medical equipment.

Most of the manufacturers of medical products already understand that the process of obtainment of the marketing authorisation is complex, unpredictable and has specific principles. It's related to taken measures allowing to confirm the functionality of the product reported by the manufacturer, its quality and safety. The goal of these measures is not just to bring efficient products on the market but also to reduce their risk for human health.

Due to this fact, the registration procedure can be divided into several stages , each of which is necessary and has own special aspects.

Formation of the registration dossier is the first stage of registration which involves preparation of materials characterizing the medical product for submittal to the registering authority. This stage is the key one in the registration process and requires special preparation to the state registration procedure. ПList of the documents required for registration is approved in Decree of the Government of Russia No. 1416 dated 12/27/2012, clause 10

Application for registration of a medical product
Commission of authority
Documentation on the manufacturer's/applicant's company
Certificates for products/raw materials
Documents/certificates for manufacturing
Technical documentation for the medical product
Operational documentation for the medical product
Reports of toxicological tests
Reports of techhnical tests
Please note!
An additional document is required for foreign manufacturers of medical products — Samples import permit

The process of registration of medical products , should be regarded with full responsibility and special attention, and all actions should be coordinated. Such seriousness is reasonable as the members of Roszdravnadzor study the registration documents with the greatest attention.

In our practice, applicants quite often prepare the registration dossier by themselves but get denial. It leads to additional time and financial expenses which pose certain risks to the enterprise. The causes may be different: Lack of experience, outdated knowledge of the specialist, amendments to the legislation during registration, etc.

To prevent unnecessary risks, please contact experts in this area and don't waste your valuable time!

We can offer you:

    • To form the registration dossier for the medical product in accordance with requirements of the registering authority provided that all required documents from the manufacturer and protocols of tests are submitted.

The cost is ₽30,000, work time is 3 business days.

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    • • To form the registration dossier for the medical product in accordance with requirements of the registering authority including working out of the kit of required technical documents

The cost and time are agreed individually and depend on the number of documents to be developed and the tests to be conducted.

Find out the cost

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