Ural Gost Certification Center. Registration certificates for medical devices free download State Register of Medical Devices

Current legislation obliges manufacturers (importers) to obtain permits for the manufacture and sale of most types of products. These can be certificates (declarations) in the TR CU or GOST R system.

Voluntary conformity assessment is also in demand.

Documents are issued by specialists from the Uralgost certification center.

Benefits of Conformity Verification

In Russia, only certification of certain goods is mandatory. Their names can be found in RF PP No. 982 and technical regulations of the EAEU.

Services, works and management systems undergo conformity assessment only at the request of the entrepreneur. Company managers strive to acquire documents on their own, because the presence of voluntary certificates helps them take high places in the rankings and improve financial performance.

Here are examples of competitive advantages:

1. meeting the expectations of large customers (for example, chain stores or government enterprises);
2. fulfillment of the conditions for participation in the SRO;
3. increased liquidity and value in the stock market;
4. access to the international level;
5. expansion of consumer markets;
6. reduced rates on loans and insurance contracts;
7. loyal attitude of supervisory authorities;
8. the right to special marking with a single quality mark;
9. increasing customer confidence.

Advantages of obtaining certificates at the Uralgost center in Yekaterinburg

A selection of the most important documents upon request State Register of Medical Devices(regulatory acts, forms, articles, expert consultations and much more).

Judicial practice

The healthcare institution committed violations in the field of medical activities: there is no mandatory equipment in the office of the ENT doctor and ophthalmologist; paid ophthalmological services are provided to minor patients using equipment that is not on the list of the state register of medical devices approved for use; the nurse performing physiotherapeutic procedures does not have the appropriate qualifications.

Articles, comments, answers to questions: State Register of Medical Devices

Open the document in your ConsultantPlus system:
The court indicated that the belonging of imported goods (equipment) to medical equipment products (taking into account their technical and design features) is confirmed by the technical description of the goods, a certificate of conformity, a registration certificate, as well as a letter from the manufacturer of the goods containing a description of the goods. A registration certificate was issued for this product in the prescribed manner, according to which the specified equipment is a medical equipment product registered in the Russian Federation in the state register of medical products and medical equipment. The certification body established the compliance of this equipment with the requirements of GOSTs and determined the code - 94 5140 according to OKP - OK 005-93 "Medical equipment. Equipment for air purification and enrichment" (approved by Resolution of the State Standard of Russia dated December 30, 1993 N 301). The belonging of imported goods to the List of the most important and vital medical equipment (approved by Decree of the Government of the Russian Federation of January 17, 2002 N 19) is confirmed by a certificate of product conformity and a registration certificate.

Open the document in your ConsultantPlus system:
The registration certificate serves as the basis for inclusion in the State Register of Medicines and the State Register of Medical Devices and Organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.

In order for a medical institution to undergo licensing, it is necessary to provide registration certificates for all medical products that are in use in this medical institution, be it a clinic or a hospital. However, these are often lost due to some circumstances. Then websites will come to your aid where you can search for registration certificates, nicknamed “regs” among medical staff.

What are registration certificates for medical devices

This is a document certifying that this medical product is registered on the territory of the Russian Federation and entered into a special database - the State Register of Medical Products and Medical Equipment.

All medical products must have certificates, and if they are missing, this means that this medical product cannot be sold and used in the Russian Federation.

Search for registration certificates for medical products

1. The Roszdravnadzor website searches for registration certificates for medical purposes. At the link you will find the Unified Register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.
   How to use the Unified Register? In the search bar you can enter the name of the medical product or its registration number. For example, we need to find an angular tip in the certificate, then we enter “angular tip” (without quotes) into the search. Many results will appear before us. When searching, you first need to focus on the validity period of the registration certificate. If you do not find the document you need, then expand the search and filter it by the data you need.
   
   To view the search result, click on the line as in the screenshot above (highlighted in red). A pop-up window will open where you can download the document. If you are not satisfied with the document, close the window and continue searching.
   
   
   Example of a found document:
   
   How to find a registration certificate by its registration number? To do this, enter the registration number you need into the search. Example RZN 2016/4700 (registration number of the digital fluorograph "FC Proton" and perform a search.
   
   
   View the document again by clicking on the line and download it from the pop-up window. Example document:
   
2. The Nevacert registration center website has its own page with a search for registration certificates in a unified register. It must be said that the page has a single database and a single search mechanism, like the search on the Roszdravnadzor page, but perhaps a more friendly interface will appeal to more users. When you hover over a search result, brief information will be displayed, and when you click on it, full information will be displayed with the ability to download the RU in PDF format or as a scanned image.