Medical registration certificate. Registration certificate of the Ministry of Health Roszdravnadzor registration certificate for medical equipment

To pass medical institution licensing, it is necessary to provide registration certificates for all medical products that are in use in a given 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 - State Register products medical purposes 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

The Roszdravnadzor website searches for registration certificates for medical purposes. Follow the link to find the Unified Register medical products 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:
The Nevacert registration center website has its own page with a search for registration certificates by unified register. I must say, the page has single base 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, and in the form of a scanned image.

The registration certificate is called official document, which is issued in accordance with the requirements and standards Federal service for supervision in the field of healthcare - the Ministry of Health. This certificate is required for private entrepreneurs and legal entities for the sale of specific products. Having a registration certificate is mandatory requirement, if you plan to import, sell and use equipment and drugs in the healthcare sector.

Our specialists will help you quickly get registration certificate Ministry of Health. You provide a minimum package of documents and we begin work without prepayment. Over 7 years, we prepared 14,000 documents for 3,500 companies in Russia, Belarus and Kazakhstan.

Important! If an enterprise does not have such a certificate, it cannot legally manufacture and sell medical grade goods.

Medicines subject to registration

Article 13 F3 No. 61 details which drugs require a certificate:

New items– medicines enter the market for the first time Russian Federation Accordingly, they have never been registered in our country;
Changed combinations– if certified drugs are used in new combinations, then these compositions require state registration;
Another approach– this list also includes drugs that have been registered and are produced in a new dosage or other dosage forms.

The law also defines drugs for which registration certificates from the Ministry of Health of the Russian Federation are not permitted to be issued. The first group includes drugs that have the same trade name, but differ in composition. In the second group there is one drug claimed for state registration, as two or more drugs, but marketed under different brand names.

There are exceptions in which a registration certificate from the Ministry of Health is not required:

Medicines manufactured by individual entrepreneurs and pharmacy organizations who already have a license for pharmaceutical activities;
Drugs that were purchased for personal use in other countries;
Radiopharmaceuticals manufactured by medical companies in accordance with the legislation of the Russian Federation;
Drugs imported into the territory of our country for examination and clinical trials with a view to further obtaining approval.

Medical products subject to registration

Any instruments, devices, materials, as well as tools that are used in medical practice must be certified. The Ministry of Health has developed a classification that allows you to accurately identify products used in medical field. The equipment is classified according to the degree of risk to the patient’s health:

Class No. 1– the risk is minimal, this includes evukoreaktotestors, microscopes, scales and other equipment that has virtually no contact with the consumer;
Class No. 2a – the average degree of risk, which includes audiometers, alcohol meters and an extensive list of laboratory equipment;
class No. 2b – increased risk (cardiac analyzers, defibrillators, etc.);
Class No. 3– high risk, this includes implants, lithotritors, endoprostheses, etc.

The process of obtaining a certificate and its features

The document is issued by federal executive bodies. You need to prepare a set of documents determined by the Ministry of Health. During registration, specialists check all the documents provided by the applicant, then samples of the drug or products are transferred to the laboratory for testing. If the results are positive at all stages, then the applicant is issued a registration certificate from the Ministry of Health of Russia - the legitimacy of the document can be checked at any time in the registry.

To the registry medical supplies and products the following information will be entered:

Name and address of the manufacturer;
Name and address of the individual entrepreneur or legal entity;
Purpose and name of the product;
Product type and risk class;
Information about interchangeable drugs or equipment;
Registration date and number;
Validity period of the registration certificate.

The certificate is issued for an unlimited period, therefore individuals and entrepreneurs receive a document for one type of goods, similar in purpose, manufacturing method and properties.