Registration of medical devices.

 State registration of medical devices are subject to the following (medical devices):

  • sutures, bandages;

  • all kinds of equipment and machinery;

  • instruments, tools, kits of reagents;

  • items of different materials (plastic, rubber, etc.);

  • dental materials and others.

For registration of medical devices available documents, consisting of the following samples:

  • the application for registration of medical devices (2 copies.);

  • certificate of medical devices;

  • a receipt for paid state tax;

  • registration documents of the manufacturer, which is a legal entity;

  • notarized copy of the contractor a power of attorney in the case,if by the manufacturerthe applicant is not;

  • documents about the conditions of production of medical devices, compliance with the legislation of the Russian Federation;

  • documents confirming the testing of the CP to the subject of technic characteristics.

  • operating instructions of medial devices,

  • reagent and physical therapy devices, used by the consumer by himself.

  • an inventory of available documents.

The specialists of the registration center will examine the registration documents and check the correctness of their filling, will give an initial assessment of the appointment of each product and determine the type of medical devices and potential risks in each product application.

In addition, experts will identify code Russian Classification of medical devices,will keep track of all stages of registration,prepare documents for technical and toxicological tests and clinical studies of each product.

Also the responsibility of specialists includes filing documentation prepared in ‘’Росздравнадзор’’receiving incoming number and arrangement of registration certificates.Preparation registration certificate occurs within 3-8 months.

 

Clinical trials of medical devices from "Evrostroj"

We invite you to take advantage of our company. Professional testing of medical devices is a work, where we are professionals.

Our company offers:

  • Registration of documents required for registration of medical devices

  • Small prices

  • Efficiency in testing and certification.

In further testing and certification the company need to have a large experience of working and high qualifity. Our employees have everything you need in order to perform the required amount of work as soon as possible.

 

Clinical and technical trials of medical devices.

Currently, clinical trials of medical devices, should condact only a companies who have a license for medical activities and they must to protect confidential information.

We are accredited by the Federal Service Authority, and that meansthat the "Evrostroj" has the right to issue and register the declaration of conformity.

Why is so necessary certification procedure of medical devices? The clinical trials of medical devices should carry out to ensure for safe use of purchased or manufactured goods and services.

Technical testing of medical devices is carried out for a period not exceeding 30 days. In carrying out this type of testing is implemented:

  • Identification of medical devices and products;

  • The establishment of a class of potential risk;

  • Analysis of the documentation;

  • The test sample;

  • Checking the safety and quality of data that relate to the product;

  • Processing of technical documents in accordance with the conduct of experiments.

Upon receipt ofpermits in Russiathis type of product can distribute many distributors. "Evrostroj" realizes full range of services for the registration and certification of medical technology areas.

We organize clinical trials of medical devices, technical and toxicological experiments. Also we translate documents quickly and efficiently into the Russian language, carrying out the examination of documents in agreement with the requirements of the ‘’ Росздравнадзор’’ of Russian Federation. Also we make out a certificate of conformity for a period of 1 or 3 years.

After a series of studies you will be able to use a legitimate basis and sell medical products.

Registration of the packaging materials as the medical wares (1 class of danger)

The list of documents needed for registration of documents and materials

1. Certificate of Compliance to EC Directive 93/42/EC (including information about the name, risk class and GNDM code).

2. Certificate ISO 13485 (including information about location of the production site).

3. The documents confirming the legitimacy of the company registration in the country of production.

4. The power of attorney includes:

a. Denomination of the company of owner of registration certificate

b. Denomination of the company that authorized by the producer to perform acts of registration.

The power of attorney must have the right of property which is entrusted to third parties without the consent of the producer.

5. Technical file includes: doc ico

a. Description of medical wares (including pictures/drawings, description of the material, methods of sterilization and validation)

b. Instructions

c. Photos

d. Production scheme

e. Packaging and applying labels

f. Storage conditions

g. Requirements for the recycling and compliance with environmental standards

h. Security questions.

6. Clinical Report - confirmation from the producer about the use of the actual package in the pharmaceutical industry.

7. The description of potential risks.

8. Samples (20-30 units of each type).

Notes

  • The materials of which produce medical devices are described in detail as much as possible - the type, brand, etc.

  • Administrative documents (from 1 to 4) must be apostilled. Translated into Russian and notarized (we recommend our colleagues from the Vialtek Group http://www.vialtech.ru/index.html).

  • The technical file can be filed in Russian, but it must be stitched and authenticated on the back by the producer’s stamp.

Stages of registration

Stage 1:

  • Must be issued a power of attorney.

  • We negotiate with the testing laboratories and conclude an agreement with them on the technical, toxicological and clinical tests.

  • Laboratories calculates the number of articles required for tests.

  • We get the permission for importation and provide exportation of the necessary samples.

  • Tests will be conducted (at the time of conducting there must be the technical file on the base of which tests will be conducted and the information about the clinical efficacy (used in the pharmaceutical industry).

Stage 2 (after reception of all the reports and conclusions) State registration:

  • Formed a package of documents according to the list.

  • Protocols and conclusions from the research centers.

  • Payed the state fee for the issuance of the registration certificate for the products of 1 class of danger.

All this documents is dealt to Roszdravnadzor and the registration certificate issued.