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State registration in the Russian Federation

Russia belongs to countries which allow to include only medical devices having passed the state registration, necessary trials and having obtained a special permission of the authorized government body into the circulation at their territory.

Consideration of safety and efficacy of medical devices applied for registration is monitored by the Federal Service of Surveillance in Healthcare – Roszdravnadzor.

Registration in Roszdravnadzor is obligatory for all medical devices including devices having an approval according to form 510 (k) of the Food and Drug Administration of the USA (FDA) and European conformity mark CE.

Risk classification of devices

On 06 June, 2012, the Ministry of Health of the Russian Federation introduced a new classification of medical devices in Decree No 4. In particular, depending on the potential risk all medical devices are divided into four classes:

  • class 1 - medical devices of low risk;

  • class 2a - medical devices of average risk

  • class 2b - medical devices of increased risk

  • class 3 - medical devices of high risk.

The risk depends on the intended purpose and conditions of medical device application. The following criteria are assessed:

  • operational lifetime of medical devices;

  • invasive character of medical devices;

  • contact or interaction of medical devices with the human body;

  • the way of introducing medical devices into the human body (through a body orifice or surgically through the surface of the body;

Full list of documents for registration

DOCUMENTS TO BE AFFIXED WITH APPOSTILLES AND TRANSLATED INTO ENGLISH/RUSSIAN:

1. Power of attorney issued by the manufacturer to the authorized juridical entity (in the name of its director indicating legal addresses and names of the company) for registration at the territory of the Russian Federation (attested and apostilled), translated into English/Russian.

2. Certificate registration of the company, business-license of the manufacturer in the country of the manufacturer and/or other countries (attested and apostilled), translated into English/Russian.

3. ISO certificates 9001/13485, declarations/conformity certificates, EC certificates – foreign documents (national and international) confirming that a medical device complies with the requirements of national and/ore international reference documents and characterizing the conditions of its production (attested and apostilled), translated into English/Russian.

DOCUMENTS TO BE STAMPED AND SIGNED BY THE MANUFACTURER AND TRASLATED INO ENGLISH:

4. Risk management file – a list of dangers connected with the application of a medical device and description of measures and ways to ensure tolerability of residual risks.

Файл менеджмента риска – перечень опасностей, связанных с применением МИ, и описание мер, способов, принятых с целью обеспечения допустимости остаточных рисков.

5. Clinical report.

6. Reports on sterilization, validation, biocompatibility test-reports – description of technological processes influencing the safety of a medical and methods of their control. Regarding sterilization processes, as a rule, detailed information on the sterilization method, achieved sterilization efficacy, applied standards, sterilization protocol in accordance with applied standards (for instruments, implants and other medical devices contacting with the internal environment of the human body) is indicated.

7. Description of materials (with trade marks and manufacturers) contained in the key functional elements, blocks, parts of medical devices including material contacting with the human body.

DOCUMENT TO BE TRANSLATED INTO ENGLISH:

8. List of applied national and international standards to ensure safety, efficacy and quality of medical devices.

9. Medical note of the medical device with the information on its intended use and main characteristics.

10. Catalogues, advertising and illustrative materials.

11. Instruction manual for a medical device.

12. Foreign technical documentation and technical protocols.

13. Quality photographs (size not less than 180х240 mm) of a medical device – OF ALL DESIGN VERSIONS.

14. Photographs of a medical device labelling, labelling of inner and outer packaging of the medical device.

14. Photographs of a medical device labelling, labelling of inner and outer packaging of the medical device.

15. Requirements and information on labelling.

16. Requirements and information on safety.

17. Requirements and information on environmental protection including requirements for safe destruction and disposal.

18. Requirements and information on life span or expiration date.

19. Requirements and information on transportation and storage.

20. Manufacturer’s guarantees.

Difference between notions “Applicant”, «Holder» and «Authorized manufacturer’s representative»

An Applicant for registration of medical devices in the Russian Federation can be a manufacturer that is a resident of one of the countries of the EAEC or his Authorized Representative. Manufacturers that are not residents of the EAEC have to find an Authorized Representative to initiate the registration procedure.

Authorized Manufacturer’s Representatives (AMR) can be a Russian juridical person or resident of the EAEC. Such an authorized person – with an impeccable reputation and wide experience in registration in the Russian Federation – works for INTRAROS CO., LTD> He ensures representation in Roszdravnadzor and settlement of questions regarding service and reclamations in the future after having obtained the marketing authorization (MA) in Roszdravnadzor.

An MA holder can be any company upon request of the manufacturer’s – the very manufacturer of the medical device, foreign representative of the manufacturer, Russian juridical person – in this regard law requirement are quite flexible.

Registration stages

Registration stages

Collecting of documentation

Preparation of necessary documentation for medical devices according to the list, photographs and samples

Manufacturer

Documentation audit, preparation of an Application for Registration, translation of the documents into Russian and notarial attestation if necessary
correction of technical files according to Russian legislation, search for registered analogues of medical devices

INTRAROS CO., LTD.

First registration stage *

Technical tests

Test center accredited to carry out technical tests

Toxicity tests

Test center accredited to carry out toxicity tests

Audit of protocols of technical and toxicity tests

INTRAROS CO., LTD.

Payment of state duties for registration

INTRAROS CO., LTD.

Expert examination of the first stage, issue of the permit to carry out clinical tests

Roszdravnadzor

Second stage *

Clinical tests

Test center accredited to carry out clinical tests

Audit of protocols of clinical tests

INTRAROS CO., LTD.

Expert examination of the second stage, decision to issue a marketing authorization

Roszdravnadzor

Obtaining of the Declaration of Conformity or letter of exemption

Obtaining of the declaration of conformity or letter of exemption explaining the absence of necessity to obtain the mandatory declaration in Rosstandart (the Federal Agency on Technical Regulation and Metrology)

INTRAROS CO., LTD.

* Devices of the first risk class are registered in one phase.

** For devices of risk class higher than the first.

Registration documents

State marketing authorization model

Describe necessary elements with footnotes

Declaration of Conformity

Describe necessary elements with footnotes

Unification of the registration procedure, integration of The Eurasian Economic Community

On 29.05.2014 the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation signed “Treaty on the Eurasian Economic Union” and were further followed by a number of other countries. Based on article 100 of this Treaty starting with 01.01.2016 the market performance of medical devices within the Union has been carried out.

Since 01.01.2016 there has been an opportunity (which, unfortunately, is not put into practice so far) to register medical devices at the manufacturer’s option either in one country (at option – in Belarus, Kazakhstan, Russia, Kyrgyzstan, Armenia) or within the Customs Union on an international base.

A transitional period for harmonization of the legal framework and standardization has been established till 31.12.2021. During this period depending on the procedure manufacturers will choose the territory of further circulation of medical devices will be determined till 31.12.2021. Upon registration on a national base (for instance, in Russian or Roszdravnadzor) afterward a medical device will circulate only on the domestic market, within the country. For free circulation at the whole territory of the EurAsEc it is necessary to undergo the registration procedure according to unitary standards of the EurAsEc.

However, unfortunately, at present (as on December, 2017) none of national authorities of the participants of the EurAsEc has not started the registration by new standards yet. The procedure of harmonization of national laws is rather complicated and long. Experts estimate that first applications for obtaining of MA of the EurAsEc will be accepted in the second half of 2018 – 2019.

FAQ

How long can the registration last if it is handled independently?

Expert help in the sphere of compliance with national standards in necessary and important as, otherwise, the dossier will not pass the first expertise stage in Roszdarvnador and will be deсlined on formal grounds. Moreover, national standards in the RF do not always fully correspond with international standards ISO and, besides, local statutory acts are valid in Russia, which often are reconsidered and updated. We thoroughly monitor all legislation amendments and check the dossier on its full conformity with current requirements. Thus, we minimize the risk of rejection on formal grounds, save our clients’ time and decrease the service cost (including payment of duties).

Nevertheless, if you have to handle the registration in the RF on your own, the risk is high that you will continue until you are aware of all the details. It can occupy more than a year.

How often to rejections occur at the first registration stage?

Experience shows that very few dossiers pass the first stage without demurs from Roszdarvnador. Such circumstances should be accepted and you should be ready to correct and reapply the dossier within 1 month after the receipt of the demurs.

Should the duty be paid upon repeated filing of the dossier after eliminating the faults?

Yes, it should be paid again. This is one of the reasons experts of Roszdravnadzor pay so much attention to the dossier content at the first stage.

How to choose a test laboratory?

Tests may be carried out only in accredited institutes and laboratories of Roszdravnadzor. Their list is on open access on website http://www.roszdravnadzor.ru/ and is updated on a regular basis.