RUSSIAN MEDICAL DEVICE REGISTRATION

1. Overview

2. Groups of medical products

3. The list of medical products and goods to be declared

4. Required documents

5. Price calculation

The concept of medical devices covers a wide range of products – from equipment, consumables to medical furniture. Products for medical purposes are divided into classes according to the degree of risk and function – the source of energy, the way of interaction with the human body, etc. For their legal use in medical institutions of the Russian Federation and Customs Union, all medical devices must pass the registration in the Federal Service for Surveillance in Healthcare register.

There is a Global Medical Device Nomenclature.

Medical products can be divided into 2 groups:

1.By their degree of security:

2.By function (energy source, vital functions, the way of interaction with the human body, the duration of use, invasiveness).

Software used for medical devices gets the same class as medical devices for which it is intended and also applies to medical devices. All medical devices must be registered in the State Register of Medical Devices of Roszdravnadzor for their legitimate use in health facilities of the Russian Federation. According to the list of products subject to mandatory declaration in the GOST R system medical equipment must have a declaration of conformity.

For the largest number of medical goods, you need to issue a declaration of conformity, but there are also medical products for which a certificate of conformity is required in the GOST R system. You can find out what a medical product is subject to certification or declaration in the list of products subject to certification and declaration in the GOST R system.

he list of medical products and goods to be declared includes:

•  Latex products and adhesives for medical purposes (surgical gloves, medical glue, diagnostic gloves, etc.)

•  Rubber products for medical use (rubber tubes, etc.)

•  Paper goods used in medicine

•  Means for dressing (materials for surgery, gauze, cotton wool medical, napkins, bandages, cotton-gauze products, etc.)

•  Medical glass containers (for blood, substitutes, medicines, etc.)

•  Fixing and compression elastic products made of synthetic threads

•  Facial protective shields

•  Medical furniture

•  Medicines passed the state registration

•  Medicines

•  Drugs and vitamins for humans and animals

•  Prosthetic and orthopedic products

•  Animal vaccine sera

•  Medical instruments, syringes, etc.

•  Medical equipment

Thus, for the implementation of medical equipment and products within the framework of the current legislation it is necessary to go through the procedure of registering medical products in the Federal Service of Roszdravnadzor and obtain a Registration Certificate. To do this, you must: apply for registration, provide samples of medical devices and the necessary documents. Roszdravnadzor performs examination of documents, as well as testing of samples and toxicological, biomedical and sanitary-hygienic studies. After these checks, in the event of a positive result, Roszdravnadzor shall enter the medical device in the State Registry and issue a Certificate of Registration.

After receiving the Certificate of Registration, mandatory certification of medical equipment in an accredited certification body follows in the form of a GOST R declaration of conformity or certification. The application and the required certification documents are submitted. Documents submitted are subject to examination. If the result of the examination is satisfactory, then the applicant is issued a declaration of conformity.

The following documents are required for registration of the declaration or certificate:

•  Application

•  Product Test Reports

•  QMS certificates, quality declarations, raw materials certificates (if available)

• TIN Certificate

• OGRN certificate

• Charter

• For imported products – shipping documents

The concept of medical devices covers a wide range of products – from equipment, consumables to medical furniture. Products for medical purposes are divided into classes according to the degree of risk and function – the source of energy, the way of interaction with the human body, etc. For their legal use in medical institutions of the Russian Federation and Customs Union, all medical devices must pass the registration in the Federal Service for Surveillance in Healthcare register.

How to get a medical registration certificate and what to do next?

To register a medical product, you must: apply for registration, provide samples of medical equipment and the necessary documents.

A list of the key documents from the manufacturer:

• ISO 13485, with Apostille

• ISO 9001, with Apostille

• CE / 93/42 from the certification body, with Apostille

• Extract from the Chamber of Commerce of manufacturer, with Apostille

• Power of attorney for the authorized representative, with Apostille

• Free sale Certificate (if available), with Apostille

• A document confirming the fact of registration of products in the country of origin (if available), with Apostille

• Risk analysis of production, assures by manufacturer

• Data validation of the sterilization process, if the product is subjected to sterilization, assures by manufacturer

• Information about the sterilization process, method, method parameters

• Test report on the claimed products held in the country of the manufacturer, assures by manufacturer

• Clinical studies carried out on the territory of the country of origin, or a program of clinical trials, assures by manufacturer

• Information on the use of standards (DIN, ISO, JIS, EN, BS EN, etc.) in the country of origin, in the form «number and title» of the standard, assures by manufacturer

• Technical file the STED DHTF form, assures by manufacturer (For processing to send in electronic form)

• User’s manual

• Instructions for use for the market of the Russian Federation, assures by manufacturer.

A list of the key documents from the authorized representative in the Russian Federation:

• Layout of marking for the market of the EAC, certified by an authorized representative of the manufacturer

• Layout of packaging for the market of the EAC, certified by an authorized representative of the manufacturer

• Application for registration (must specify exactly which model it is necessary to register), certified by an authorized representative of the manufacturer

• The application for the import, certified by an authorized representative of the manufacturer

• Label, certified by an authorized representative of the manufacturer

• Pictures of the products certified by an authorized representative of the manufacturer

• Extract from EGRUL

• The certificate of registration (a notarized copy)

• Samples for the technical, toxicological, clinical trials.

Federal Service for Surveillance in Healthcare conducts a documentation expertise, as well as sample testing and toxicological, biomedical and sanitary-hygienic tests. After these tests, in case of a positive result, the Federal Service for Surveillance in Healthcare enters the medical device into the State Register and issues a medical registration certificate. For successful further sale of medical devices, it is not enough just to register them. Next, you need to issue an EAC declaration, which confirms that the product meets the standards specified in the technical regulations, has the necessary qualities and characteristics for effective use in relation to its purpose. For some groups of goods, you will have to issue a certificate of conformity in the GOST-R (Russian National Standard) system. We will advise on these issues and show you what type of certification you need to complete for a specific type of medical equipment.

Pass all the procedures for the use of medical devices in Russia quickly and without unnecessary hassle

Our company has been providing comprehensive certification services for more than 9 years and helps to pass all tests for the successful import, sale and use of various products in the territory of the Eurasian Customs Union. The accredited body has all the resources to quickly resolve the issue with minimal worries for the client. Contact us.