Facilitated registration of medical devices

Due to restrictive economic measures taken by the unfriendly countries in relation to Russia, we face a risk of inventory shortage (deficiency) of medical devices.

As a measure to prepare preliminarily for possible shortage of provision of medical devices and their deficiency for ultimate purchasers, the government of the Russian Federation has developed and adopted the Resolution dated 04/01/2022 No.552 «On confirmation of trade peculiarities, including the features of state registration, of medical devices in case of shortage or risk of deficiency in view of implementation of restrictive economic measures against the Russian Federation» (hereinafter – the resolution).

The resolution establishes the following:

  • facilitated procedure of registration of medical devices included into the List of types of medical devices subjected to trade according to the resolution. Peculiarities of registration of different types of items;

  • facilitated procedure of correction of registration dossier (portfolio) of medical devices produced in Russia due to change of used raw products, materials, components, composed units, accessories;

  • facilitated procedure of change of documents included into the registration dossier of the items specified in the List.

The List of types of medical devices subjected to trade according to the Resolution

According to the Resolution, the List of types of devices includes:

  • medical devices in case of their deficiency (shortage of suggestion in the market) or a risk of deficiency;
  • medical devices for which delivery offers at price lower than the average market price are made to the multiagency commission;
  • other medical devices determined by the multiagency commission.

This List should be accepted by the multiagency commission represented by the Ministry of Healthcare, the Ministry of Industry and Trade, the Ministry of Finance, the Ministry of Economic Development, the Federal Anti-Monopoly Service, the Federal Revenue Service, the Federal Customs Service, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and other bodies and authorities when required. Such an extensive participation of various legal bodies is determined by the need of objective inclusion of one or another device into the List. The List should be placed on the web-site of the Federal Service for Surveillance in Healthcare.

Currently, the List includes 1619 types of medical devices. The Resolution also defines the procedure Introduction of amendments to the registration certificate and the registration dossier!

In some aspects, the Resolution differs significantly from the Rules of state registration of medical devices accepted by the resolution of the Government of the Russian Federation dated the 27th of December, 2012, N 1416 «On confirmation of the Rules of state registration of medical devices». Thus, we consider the precise situations and peculiarities of trade of the devices in case of their deficiency or risk of shortage.

Peculiarities of state registration of medical devices included into the List

The procedure of facilitated registration is prescribed by Section II of the Resolution. This procedure is valid till the 1st of September, 2023 (as well as the registration certificates issued according to this scheme!). The detailed action order is given in the scheme.

Scheme of state registration of medical devices included into the List

For registration, the applicant should assign the following documents to the expert authority:

Table 1

wdt_ID No. Name of the document Comment
1 1 application on state registration of the medical device made according to the requirements to the contents of such an application established by the Rules of registration information that should be contained in the application is specified in point 9 of the Resolution of the Government 1416 dated the 27th of December, 2012
2 2 copy of a document that approves the qualification of a plenipotentiary of the manufacturer (vendor) letter of authorization. The document should be submitted according to the international legal rules
3 3 original document that approves the qualification of a body authorized for import of a medical device to Russia for state registration (by applicability) the applicant can be a body that imports the medical device to the Russian Federation (an importer)!
4 4 documents that confirm that the medical device belongs to the body that imports the device to the Russian Federation to register it legally (by applicability) invoice
5 5 the manufacturer (vendor) technical documentation for the medical device corresponding to the requirements set by the Ministry of Healthcare of the Russian Federation according to the requirements of section II of the Order of the Ministry of Healthcare of the RF dated the 19th of January, 2017, N11н
6 6 the manufacturer (vendor) operational documentation for the medical device corresponding to the requirements set by the Ministry of Healthcare of the Russian Federation according to the requirements of section III of the Order of the Ministry of Healthcare of the RF dated the 19th of January, 2017, N11n
7 7 photographic images of general view of the medical device including the accessories required for intended use of this medical device (size of the image should be not less than 18x24 cm) the image should be colorful for determination of modifications of the device produced in various colors
8 8 photographic images of an electronic medium and a software interface (when used) (size of the image should be not less than 18x24 cm) – for the software considered as the medical device, including the software based on technologies of artificial intelligence see the previous comment
9 9 documents that confirms the results of technical testing of the medical device, toxicology research of the medical device and (or) accessories for the medical device that contact directly or indirectly the human skin, mucus membranes, internal milieu of the body (for which such an influence (contact) is required to perform their functions), clinical testing of the medical device performed according to the type test procedure in dependence from the type of the medical device developed by an expert body (by applicability), or in a form of estimation of compliance of the medical device according to technical testing, toxicology research, clinical testing required for state registration of medical devices in the order established by the Ministry of Healthcare of the Russian Federation for any device from the List (peculiarities of the scope of documents that confirm the results of testing and research for some Russia-made and imported devices are given in points. 9.1, 9.2).
10 9.1 AS PER THE APPLICANT’S CHOICE FOR DOCUMENTS IN POINT 9: documents of the manufacturer and (or) companies that perform technical testing, toxicology research (with the corresponding results) that allow to estimate the applied methods and the list of the test equipment Russia-made medical devices (except for the implantable devices and the devices manufactured in the sterile form)

Documents of the manufacturer (vendor) given in the table (except for the document that confirms the qualification of a body authorized for importing of a medical device to the RF) should be authenticated by the manufacturer (vendor) or by an authorized representative of the manufacturer (vendor).

Authentication by an authorized representative can be accepted if the Federal Service for Surveillance in Healthcare possesses a document that confirms that the representative is legally authorized to authenticate the documents. The document that confirms the qualification of an authorized representative must come into force before issuing of the documents to be authenticated.

In case when the specified documents are in a foreign language, they should be submitted with translation to Russian confirmed according to the established order.

The Resolution allows that the applicant can be not only a manufacturer or an authorized representative, but an importer as well! This helps to perform parallel import in case of further economic restrictions!

Let’s consider the features of the scope of documents that approve the results of technical and clinical testing and toxicology research (point 9 of table 1) for various types of medical devices.

Any medical device included into the List

Technical and clinical testing and toxicology research (when required) should be performed according to the type test procedure in dependence from the type of the medical device developed by an expert body, or in a form of estimation of compliance of the medical device according to technical testing, toxicology research, clinical testing required for state registration of medical devices in the order established by the Ministry of Healthcare of the Russian Federation.

Russia-made medical devices included into the List (except for the implantable devices and the devices manufactured in the sterile form)

In relation to the Russian manufacturers of medical devices, the Resolution allows that the manufacturer itself performs technical testing and toxicology research according to the standard procedure developed by an expert body without recourse to accredited test laboratories.

The manufacturer documents on the results of toxicology research and (or) technical testing should allow to estimate the applicable methods and the list of the test equipment.

Practically, this requirement means that the manufacturer should have own laboratory registered by RusAccreditation, or:

Just a few Russian manufacturers can perform testing in-house at the required level. Thus, it is much easier and faster to perform technical testing and toxicology research according to the standard procedure in an accredited test laboratory.

Foreign-made medical devices (except for the software declared as a medical device, including the software based on artificial intelligence, and medical devices for diagnostics in vitro)

For this category of medical devices, it is allowed to submit the documents that approve the fact of registration according to the established order in the manufacturer country (СЕ certificate, FDA, etc.) with applied documents that confirm clinical efficiency and safety of the medical device to be registered (clinical evaluation report) instead of clinical testing in the Russian Federation. This allows to reduce the period of preparation of the registration dossier and to reduce significantly the expenses of the registration works.

The registration certificate issued according to section II of the Resolution is valid till the 1st of September, 2023. However, at any time before the registration certificate becomes invalid, the manufacturer of the medical device or an authorized representative can submit a letter of application for state registration and a set of documents specified by the Registration rules to the Federal Service for Surveillance in Healthcare to register the medical device and to get an unlimited registration certificate. The detailed procedure of issuing of the registration certificate according to the Government Resolution 1416 dated the 27th of December, 2012, is described at this page.

The only peculiarity of the affirmation is that the expert review of an application for state registration of the medical device and the documents required by the Registration rules takes place together with the expert review of the scope and the results of the performed testing and research. At this, you should pay the state fees for the second time.

This registration scheme allows the applicants to receive an unlimited registration certificate according to the national (Russian) rules that is much easier, faster and chipper than registration according to the EAEU rules.

Registration of non-sterile medical devices of the 1st risk class

For this category of medical devices included into the List, the Resolution establishes the easiest procedure of issuing of the registration certificate. It is also valid till the 1st of September, 2023. To register a device, the applicant submits the following documents to the Federal Service for Surveillance in Healthcare in print format directly or by the first class recorded delivery:

Table 2

wdt_ID No. Name of the document Comment
1 1 application on state registration of the medical device made according to the requirements to the contents of such an application established by the Rules of registration information that should be contained in the application is specified in point 9 of the Resolution of the Government 1416 dated the 27th of December, 2012
2 2 copy of a document that approves the qualification of a plenipotentiary of the manufacturer (vendor) letter of authorization. The document should be submitted according to the international legal rules
3 3 original document that approves the qualification of a body authorized for import of a medical device to Russia for state registration (by applicability) the applicant can be a body that imports the medical device to the Russian Federation (an importer)!
4 4 documents that confirm that the medical device belongs to the body that imports the device to the Russian Federation to register it legally (by applicability) invoice
5 5 the manufacturer (vendor) technical documentation for the medical device corresponding to the requirements set by the Ministry of Healthcare of the Russian Federation according to the requirements of section II of the Order of the Ministry of Healthcare of the RF dated the 19th of January, 2017, N11n

In case when the specified documents are in a foreign language, they should be submitted with translation to Russian confirmed according to the established order.

Documents of the manufacturer (vendor) given in the table (except for the document that confirms the qualification of a body authorized for importing of a medical device to the RF) should be authenticated by the manufacturer (vendor). Authentication by an authorized representative can be accepted if the Federal Service for Surveillance in Healthcare possesses a document that confirms that the representative is legally authorized to authenticate the documents. The document that confirms the qualification of an authorized representative must come into force before issuing of the documents to be authenticated.

The further actions and steps are given in the scheme.

Scheme 1 class non-sterile

Within a period not exceeding 150 working days since the date of state registration of a non-sterile medical device of the 1st risk class included into the list of medical devices, the manufacturer (vendor) of the medical device or an authorized representative should submit the application letter on state registration and the scope of documents (table 3) to the Federal Service for Surveillance in Healthcare to undergo the procedure of state registration of the medical device according to the Rules of registration.

Table 3

wdt_ID No. Name of the document Comment
1 1 application on state registration of the medical device made according to the requirements to the contents of such an application established by the Rules of registration information that should be contained in the application is specified in point 9 of the Resolution of the Government 1416 dated the 27th of December, 2012
2 2 copy of a document that approves the qualification of a plenipotentiary of the manufacturer (vendor) letter of authorization. The document should be submitted according to the international legal rules
3 3 Information on regulations for the medical device
4 4 the manufacturer (vendor) technical documentation for the medical according to the requirements of section II of the Order of the Ministry of Healthcare of the RF dated the 19th of January, 2017, N11n
5 5 the manufacturer (vendor) operational documentation for the medical device including the operation instruction of the operation manual for the medical device according to the requirements of section III of the Order of the Ministry of Healthcare of the RF dated the 19th of January, 2017, N11n

As the table shows, if there has been no changes or additional testing, the scope of the documents does not include the documents that confirm the results of testing and research for these documents are already submitted to the Federal Service for Surveillance in Healthcare at the previous stage.

The further procedure of receiving an unlimited registration certificate for medical devices with low potential risk of application during their use (except for the medical devices produced in sterile form) is described in the scheme below.

The scheme of confirmation of state registration according to the Registration Rules

Thus, the manufacturers/authorized representatives and importers of non-sterile medical devices of the 1st class risk can receive the registration certificate valid within 150 working days as soon as possible (within a month) at the minimum possible price. Then they can get an unlimited registration certificate on the basis of partially prepared and confirmed documentation.

This procedure of facilitated registration of medical devices is developed and valid for medical devices widely used under the conditions of pandemic of coronavirus infection (COVID-19).

Cancelling of state registration of a foreign-made medical device registered according to the Registration rules or Resolution No.552 on the basis of the manufacturer (vendor) or an authorized representative of the manufacturer (vendor) submitting of an application letter for cancelling of state registration of the medical device PROHIBITED!

We also should note that non-sterile medical devices of the 1st class risk can be registered both according to section II and section III of Resolution No.552 (i.e., you can use both of the mentioned schemes)!

The Resolution forbids limitation of compatibility of medical devices by means of use of special technical or program means, or by any other means with regards or their trade. It is applicable for all the medical devices registered according to the national rules, not only the ones given in the List!

It is still actual for the cases when the manufacturer (vendor) specified a restricted list of consumables in the operation instruction (manual) for the medical device. To use the consumables by another manufacturer, you should confirm the possibility of their mutual use with the device during the process of their state registration.

At the same time, mutual use of the medical device with such a consumable should be performed with considering the peculiarities specified in the operational documentation of the manufacturer (vendor) for the consumable materials. It is especially vital for the medical devices for diagnostics in vitro. Thus, the Resolution makes it possible, for example, to use non-original reagents for closed analytical schemes.

Despite some of the points of the Resolution cover only some specific groups of medical devices, together they can help to reduce significantly the terms and the expenses of the issuance of the registration certificate. And, what is the most important, the Resolution allows to get an unlimited registration certificate according to the national rules of the Russian Federation.

Currently, we are waiting for assignation of the multiagency commission that will accept the list of types of medical devices covered by the Resolution.

As soon as the list is published, we will be ready to help you to receive the registration certificate according to the simplified rules of 2022 within the shortest period.

We also currently suggest the services for registration of medical devices according to the EAEU rules, registration of lots (series) according to Resolution of the Russian Federation Government No.430, development of the documents of the registration dossier as a part of preparation works for registration according to the national rules. We also help to add amendments to the registration dossier or registration certificate of any Russia-made medical devices both within the borders of the national rules and according to Resolution No.552.

If you have a medical device to be registered, contact us by any appropriate means to get a free consultation.

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