Registration certificate. Registration certificate of the Ministry of Health Medical products subject to registration

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 obtain a registration certificate from the 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. The second group contains one drug that is submitted for state registration as two or more drugs, but is 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.

The following information will be entered into the register of medical drugs and products:

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.

Registration certificate– this is a document confirming registration medicines, medical products and allowing the release of these products into circulation on the territory of the Russian Federation. Its availability from the manufacturer or importer indicates that the medical product fully complies with all norms and standards established by national legislation and can be used for its intended purpose without the risk of causing harm to the life and health of consumers.

Good afternoon
We have our own technical center for servicing office equipment, computers, and providing IT services.
We have a desire to provide expertise services in this area, what is needed for this and what certificates or licenses are needed.
Thank you

Good day! We would like to place an order for the production of a certificate of conformity to GOST R (firewood products). Please contact us to discuss any issues that interest us.

A certificate is required for the production of vegetable or fertile soil. (Peat sand mixtures)

Good afternoon We need to get in short time phytosanitary certificate for export of cargo to Turkey
Product:
Spliced-glued timber (planed, there is a groove along the entire length of the timber, groove width 0.6 mm, depth 0.6 mm) from spruce and pine, humidity 8-12%
PVA glue D3
Dimensions:
35*42*2100
35*58*2100
30*58*2100
There are no documents on the purchase of the original raw materials; the raw materials themselves are from Arkhangelsk.
Please specify the cost and terms?
Thank you

Registration certificate of Roszdravnadzor is a document confirming that a certain product (product/device) for medical purposes is registered on the territory of the Russian Federation and included in State Register products medical purposes and medical equipment. You can always check the availability of a registration certificate in the registry on the website of the Federal Service for Surveillance in Healthcare of the Federal Service for Surveillance in Healthcare (direct link to the registry). The certificate can be issued to both a domestic and a foreign company registered in accordance with Russian legislation. A registration certificate is issued for medical devices in mandatory. Without a Registration Certificate, a medical device cannot be sold or used on the territory of the Russian Federation. In everyday life, the document can also be called a registration certificate of the Ministry of Health, this is due to the fact that previously Roszdravnadzor was under the jurisdiction of the Ministry of Health of the Russian Federation.

Basic concepts when obtaining a Registration Certificate

When obtaining a Registration Certificate, you should regulate your actions in accordance with the Order of the Ministry of Health of the Russian Federation (Ministry of Health of Russia) dated October 14, 2013 N 737n “On approval Administrative regulations Federal Service for Surveillance in Healthcare for the provision public services By state registration medical products."
Medical products are classified according to the degree of potential risk (each medical product can be assigned to only one class):
Risk class “1” – assigned to products with a low degree of risk. These are microscopes, scales, sound reactor testers and the like.
Risk class “2a” – medium risk. This category includes laboratory equipment, spirometers, audiometers, etc.
Risk class “2b” - high-risk products (defibrillators, cardiac analyzers, or, for example, AVL - artificial lung ventilation device).
Risk class “3” – high degree of risk. These are endoprostheses, implanters and similar equipment (for example, a lithotripter - a device for crushing stones in the bladder).

What documents are required to obtain a Registration Certificate?

For a foreign manufacturer:

legalized power of attorney from the manufacturer to authorized representative m();
documents confirming the registration of the manufacturer (Extract from the Chamber of Commerce and Industry or a similar document);
CE certificate Quality control system Directive 93/42/EEC for medical equipment or 98/79/EEC for in vitro diagnostic medical devices
Declaration of Conformity for the product itself in accordance with Directive 93/42/EEC or 98/79/EEC or Certificate of Free Sales;
ISO 13485:2003 or ISO 9001:2000 certificate;
technical documentation;
operational documentation;
test reports (electronic);
clinical review;

For Russian manufacturer

Technical specifications (developed or finalized by our specialists)
Operating manual (developed or finalized by our specialists)
Information about regulatory documentation

It is worth keeping in mind that additional documents may be required for components of a medical device.
If Medical equipment equipped measuring instruments– sensors, thermometers, etc. – to obtain the RU, you first need a certificate of approval of the type of measuring instruments. You will also need samples for testing (the number of samples depends on the complexity of the product and the requirements for its testing).

You can always contact Roszdravnadzor directly

or contact specialists and not waste your time studying all the necessary documents

Services and advantages of our company

Our experience in preparing Registration Certificates will help give you professional advice on every issue related to notification and its execution.
We issue test reports only in accredited laboratories. Full list Laboratories by test category can be found on the Roszdravnadzor website.
Assistance in preparing the submission of documentation to Roszdravnadzor.
All discussions with the authorities involved in issuing Registration Certificates, as well as tracking the entire process of obtaining RU, decision controversial issues Our company takes full responsibility for this.

What happens to registration certificates after the end of the transition period?

On this moment(until December 31, 2021), at the choice of the manufacturer of a medical device or its authorized representative, registration of a medical device may be carried out in the manner established by the Commission, or in the manner prescribed by the legislation of a member state of the Eurasian Economic Union. This transition period is intended for a “smooth” entry into the new registration procedure for medical devices within the EAEU.

So far, Decision of the EEC Council No. 46 dated February 12, 2016 “On the Rules for Registration and Examination of the Safety, Quality and Efficiency of Medical Devices” continues to apply without changes, which states that national registration certificates will cease to be valid on December 31, 2021. However, the participants of the working group (organized for the purpose of discussing and determining the rules for registering medical devices within the EAEU) agreed to make changes to the documents:

1. Registration certificates obtained according to the national procedures of the participating countries after December 31, 2021 will continue to be valid until their expiration date, namely:

for the Russian Federation: indefinitely
for the Republic of Belarus: 5 years
for the Republic of Kazakhstan: 5 years
for the Kyrgyz Republic: indefinitely
There is no national procedure for registration of medical devices in the Republic of Armenia.

2. Amendments to the documents contained in the registration dossiers of medical devices registered under the national procedure will be possible under the same conditions.

3. Registration of medical devices according to the national procedures of the EAEU member countries after December 31, 2021 will become impossible.

The size has changed since the beginning of 2015 state duties for performing actions during the state registration of medical devices and other related services:

Terms: from 3 months