Certification Center Ural Gost. Download registration certificates for medical devices for free What are registration certificates for medical devices

For passing medical institution licensing, you must provide registration certificates for all medical devices, which are in operation in this medical institution, whether it is a clinic or a hospital. However, they are often lost due to some circumstances. Then you will come to the aid of sites that search for registration certificates, nicknamed "regs" among the medical staff.

What are registration certificates for medical devices

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

All medical devices must have certificates, and if there are none, this means that this medical device cannot be sold and used in the Russian Federation.

Search for registration certificates for medical devices

The Roszdravnadzor website searches for medical registration certificates. 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 honey product or its registration number. For example, we need to find in the certificate for an angled tip, then in the search we enter “angled tip” (without quotes). We have many results in front of us. In the search, you first need to focus on the validity of the registration certificate. If you did not find the document you need, then expand the search and filter it according to 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 the document does not suit you, then close the window and continue the search.

An example of a found document:

How to find a registration certificate by its registration number? To do this, enter the registration number you need in the search. Example RZN 2016/4700 (registration number of digital fluorograph "FC Proton" and search.

View the document again by clicking on the line and download it from the pop-up window. Document example:
The site of the Nevacert registration center has its own page with the search for registration certificates in a single registry. I must say that the page has a single database and a single search engine, which is the same as the search on the Roszdravnadzor page, but perhaps a more friendly interface will appeal to more users. When you hover over a search result, you will see short information, and when you click on it - full information with the ability to download the RU in PDF format, and as a scanned image.

The 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.

Issuance of documents is carried out by specialists of the certification center "Uralgost".

Benefits of conformity assessment

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

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

Here are some examples of competitive advantages:

meeting the expectations of large customers (for example, chain stores or state-owned enterprises);
fulfillment of the conditions for participation in the SRO;
growth of liquidity and value in the stock market;
access to the international level;
expanding consumer markets;
reduced rates on loans and insurance contracts;
loyal attitude of supervisory authorities;
the right to special marking with a single quality mark;
increasing customer confidence.

Advantages of obtaining certificates in the center "Uralgost", Yekaterinburg

Certification of medical industry enterprises is carried out on the basis of the international standard ISO 13485:2016. In domestic practice, the analogue of this regulatory legal act is GOST R ISO 13485-2017, which has been in force since 2018.

Application area

When assessing compliance with the current standard, the functioning of the quality management system at medical enterprises is studied. Such a system is formed due to the practical application of measures to optimize the production process, improve the interaction between management and subordinates, establish an organizational structure and comply with sanitary and epidemiological standards.

ISO 13485 certificate is in demand among manufacturers and designers of medical equipment,

suppliers of components and developers of medical software.

Benefits of implementing a QMS

World experience in applying a systematic approach in the management process shows that medical companies have achieved certain success in implementing QMS:

reduction in the level of defective products;
elimination of duplicating operations;
building a positive team spirit;
improving the quality of products;
saving resources.

QMS conformity assessment

You can confirm the application of the principles of effective quality management by issuing a GOST R ISO 13485-2017 certificate. Although the procedure in Russia is voluntary, it is gradually becoming inalienable. This is due to the situation in the business environment, because more and more enterprises are striving to follow world standards and increase their competitiveness.

To obtain a certificate, as well as to develop and implement the principles of the QMS, you can contact the body (center) accredited in the Promtechcertification system.

If there are human resources in the enterprise, you can start building the system on your own. However, then the process can be delayed and lead to questionable results. Therefore, it is better to entrust such work to professionals who will start the process in the shortest possible time and draw up a certification document.

Benefits for holders of ISO 13485 certification

The document brings certain benefits to the enterprise:

expansion of sales markets;
cooperation with foreign companies for which the presence of an ISO certificate from a partner is a prerequisite;
participation and victory in state tenders, competitions;
the right to appropriate labeling;
profit growth and competitiveness.

Stages of confirmation of compliance

Appeal of the enterprise with an application to the authorized body (center).
Discussion of conditions and cost of certification.
Conclusion of an agreement between the parties.
Audit of production activities, organizational structure of the applicant.
Evaluation of the qualifications of employees.
Checking compliance with sanitary and epidemiological standards.
Registration of the certificate in the register of the authority and issuance to the customer (subject to the compliance of the QMS with the requirements of the current legislation).

The certificate is valid for three years from the date of issue. At the same time, the body conducts annual inspection control over compliance with the requirements of the ISO standard.

Document appearance

The official form of the document drawn up in the Promtechsertification system informs the consumer about the most important aspects:

registration data and name of the certification body that issued the document;
the name and details of the applicant enterprise;
registration number of the certificate;
date and period of validity;
confirmation of compliance with the requirements of ISO (ISO) 13485;
signatures of the head and expert of the body, seal.

The certificate is issued together with an application that contains information about the scope of the quality management system (for example, wholesale of medical equipment and (or) manufacture of medical instruments).

If you have any questions about QMS certification in accordance with ISO 13485, please contact the specialists of the information portal "InfoGOST". Our consultations are absolutely free!