Tag Archives: Registration

Russian and Eurasian Medical Device Regulations – Highlights 2022

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  1. Russian national medical device regulatory system

    Over the several years, a deadline for the end of the Russian national procedure of the registration was set as 1 January 2022. However, a few days before 2022, the Eurasian commission came up with a protocol for postpone the national registration deadline for another year, until 1 January 2023.

    Due to the length of procedures of ratification and signing the protocol by all Eurasian Member states, the national registration procedure was closed during 6 months, and re-opened only in June 2022, when this prolongation came into force.

    In August 2022, the Council of the Eurasian Commission announced approval of further prolongation of the Eurasian transition period with possibility of medical device registration submissions according to the national regulations until 31 December 2025.

    This draft protocol has been circulated to the Member States and will come into force after ratification and signing.  In November 2022, proposal on new prolongation was approved by the Russian government, but for end of December it is not yet been enforced officially.
  • Updates in the registration procedure:

    Over the year 2022, we me may see several updates in the national registration procedure:

    -Since March 2022, a new regulations for pre-clinical and clinical testing for medical devices (link in Russian) have been enforced;

    -Since August 2022, Russian medical device regulator Roszdravnadzor simplified the process of importation of samples for testing and registration (link in Russian);

    -In September 2022, the Russian Ministry of health introduced a requirement of quality management system inspections for national registrations and renewal (re-registration) procedures of sterile IIa, all IIb and III class medical devices (link in Russian). This requirement was established with a transition period until 1 June 2023, until this date QMS inspection may be postponed for the next two years after registration approval. Since November 2022, the Russian Ministry of health is discussing extension of this deadline until 31 December 2023.

  • Updates in post-market requirements:

    It is worth mentioning two quite significant updates in the Russian post-market medical device regulation over the last year:

    Since February 2022, according to the regulation #1113 (link in Russian), Manufacturers or their Russian authorized representatives are required to submit annual clinical post-market monitoring reports for class III medical devices and IIB implantable devices registered in Russia after January 2021;

    Since March 2022, according to the regulation  #11020 (link in Russian) for the purpose of safety monitoring of medical devices on the market, Manufacturers and Distributors have to inform Roszdravnadzor within 15 days, about every unit of any medical device imported into Russia;

  • Other significant updates in the national medical device regulations:

    Since September 2022, the Russian government released the regulation #2425 (link in Russian) and updated a lists of products subject to mandatory GOST certification and declaration. Current GOST certificates and declarations of conformity for products on the market, mentioned in the previous versions of the lists, will remain valid until 1 September 2025.

    Medical and in-vitro devices intended for diagnostics and treatment of COVID-19 infection are still may be registered in Russia via simplified registration process until and receive approval until 1 January 2025.  In the same time, part of these products already registered before, have been withdrawn from the market by the regulator.



    2.Expedited registration process for medical devices in risk of shortage and other measures related to geopolitical situation

Since April 2022, the Russian government released several regulations “intended to improve the stability of the market for socially important goods and mitigate a risk of inventory shortage for medical devices caused by the economic restrictive measures imposed against Russia”.

The measures, among others, include “fast-track” medical device approval process for certain groups of medical devices and simplified re-registration procedure in case of change of the raw material and components for domestic medical device manufacturers;

The resolution #552 (link in Russian) enforced on 1 April 2022, introduced a possibility of the “fast track” registration for medical devices included the special list. Since April 2022, the list of devices, that has determined to be in shortage at this time, has been extended several times, and for the end of the year, it contains more than 1800 codes. Depending on classification of the device, (formal) timeline for fast-track review by the Regulator may start from five-business days while certain administrative and testing requirements for such submission are simplified. The registration approval for this procedure is granted for the limited period (initially established until 1 September 2023 and later prolonged until 1 January 2025). For the end of 2022, 18 medical devices have been approved according to this simplified process.

Among other measures, as a response to economic restrictive measures and complexity of the logistic process,  the Russian regulators introduced ban for export from Russia of certain medical devices included in the special list, legalized a “parallel importing” in Russia for certain goods including medical devices without the permission of the trademark holder, introduced a requirement for manufacturers and importers of medical devices to notify the regulator prior to suspend or terminate business activity in Russia.

3. Updates in the Eurasian medical device regulatory system

Overall, we did not observe a major breakthrough in the development of the Eurasian medical device regulatory system over the last year.

For the end of the year 2022, there are 14 medical devices registered according to the Eurasian medical device registration system (versus 7 approvals in the beginning of the year), most of registered medical devices are manufactured by domestic Eurasian companies;

There are 22 testing laboratories and 41 medical organizations accredited for conducting testing and clinical trials of medical devices according to Eurasian requirements;

In July 2022, the Eurasian Commission released the Regulation # 144 (link in Russian) implementing new edition of Eurasian medical device registration rules with several updates in the procedure;

In August 2022, the Council of the Eurasian Commission announced approval of further extension, until 31 December 2025, of the Eurasian transition period medical devices registration submissions open both according to national and Eurasian regulations;

In December 2022, the Eurasian Commission announced approval of the roadmap for the further transition the common market of medical devices, which, according to the Commission, will ensure “unconditional transition” for registration of medical devices after end of transition period.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, August 2022

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1.Draft Protocol on Prolongation of the Eurasian Transition Period until 2025

On 19 August 2022, the Council of the Eurasian Commission announced (link in Russian) approval of the protocol of amendments to the Eurasian Agreement on common principles and rules of circulation of medical devices and prolongation until 31 December 2025 of the transition period with possibility of registration of medical devices according to the national regulations.
According to the announcement on the website the Eurasian commission, the draft protocol with abovementioned amendments was forwarded to the Eurasian member states for carrying out procedures necessary for signing and implementation of this regulation.
The Eurasian Agreement on common principles and rules of circulation of medical devices was enforced by the Eurasian Commission in 2016; the transition period, that was initially established as 31 December 2021, was already extended for one year in June 2022.

2.Simplification of the Procedure of Importation of Samples of Medical Devices for Registration

On 8 August 2022, the Russian medical device regulator Roszdravnadzor has announced (link in Russian) change of the procedure of importation of samples of medical devices for registration in Russia. 
Since that date the requirement to obtain the sample importation permit for registration was cancelled and replaced by new requirement to submit online notification with information on imported samples. 

3.Enforcement of the Requirement on QMS Inspections for National Registration Procedure

On 1 September 2022, the regulation #135 (link in Russian) is coming into force. This document is establishing rules for the inspection of quality management systems (QMS) for medical device manufacturers and introduces mandatory requirements to perform QMS inspection and submit QMS inspection reports for national Russian registration and amendment procedures for IIA sterile, IIB and III class medical devices.

The regulation established nine months (i.e. until 1 June 2023) transition period. Within this timeline, registration and amendment procedures may be done with submission of ISO 13485 inspection report on condition that postponed inspection to be performed by the Russian component authority within 2 years after approval.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union in July 2022

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  1. New Revision of the Eurasian Medical Device Registration Rules

On 18 July 2022, the Decision of the Eurasian Commission #144 (link in Russian) came into force, implementing several significant changes in the current Eurasian medical device registration rules:

  • Updated criteria for grouping of products in one application for registration not linked with nomenclature code (see clause 19);
  • Clarified requirement to have at least one Eurasian acceptance state  in addition to reference state for registration application (see clause 16 and 21);
  • Updated requirement on list of administrative documents (e.g. mandatory contract between Manufacturer and Eurasian authorized representative – see Annex IV clause 3);
  • Updated terminology: “components”, “consumables” have been replaced with terms “composition” and “accessories”;
  • Updated requirement on QMS inspection for sterile 2a, 2b and 3 class devices henceforward may be done within 45 days after start of expert review after possible deficiencies of expert body are resolved but not before the submission (see clause 26);
  • Introduced a possibility for certain amendments in registration licenses to be done as notification without review of the competent authority (see chapter VI);
  • Some other changes.

For the end of July 2022, there are 10 medical devices registered according to the Eurasian regulations.

2. Discussions on Further Prolongations of the National Registration Procedures in Russia

 In June 2022, the Eurasian commission confirmed a prolongation of the transition period from the national to Eurasian medical dveice regulatory system and re-opened submissions on medical device registration according to the national requirements until the 31 December 2022.

In July 2022, the Russian Ministry of Health, in the response to the request from the manufacturers and distributors, admitted a possibility of the further extension of the national procedure for registering medical devices until the end of 2023.

According to the response of the Regulator, this initiative is currently being discussed internally, and the draft protocol with possible amendments will be considered by the Eurasian member states at the next meeting of the Council of the Eurasian Economic Commission.

3. Simplified Registration for Eurasian Manufacturers in Belarus

On 9 June 2022, the Belorussian Ministry of Health released the regulation #52 (link in Russian)
which provided an opportunity for medical devices manufacturers located within the Eurasian Union and having their products approved in USA and European union to pass simplified registration process in Belarus (i.e. without hygiene tests, clinical trials, and production inspections).

The same regulation introduced a new supplemented sub-clause (see 5.2.4) regarding regulation of research-use only (RUO) products in Belarus.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, January 2022

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  1. Submissions according to the local medical device regulations of the Eurasian member states are closed, but may reopen

According to the Eurasian agreement on the common principles and rules of circulation of medical devices, 1 January 2022 is the end of the transition period for device registration to move from national to the Eurasian level. 

On 30 December 2021, the Eurasian Economic Commission (EEC) released this protocol (link in Russian) confirming the transition and that all registration dossiers submitted before 31 December 2021 must be reviewed using the original rules. The protocol also confirmed that all medical devices approved locally in Eurasian states before 31 December 2021 could keep their status in the member state until their registration expires. The registrations could also be amended to comply with national rules, which are valid until 31 December 2026.

In January 2022, the Russian medical device regulator Roszdravnadzor announced the closure of submissions for new device registration files complying with the original national regulations. Medical device regulators also published same information in Kazakhstan and Belarus. 

However, on 24 December 2021, the EEC discussed new changes to the agreement, a potential reopening of submissions, and prolonging the transition period for another year. On 19 January 2022, the EEC published Decree 27 (link in Russian) approving this extension which all Eurasian member states should authorize.

In addition, at the end of December 2021, two amendments to existing Eurasian medical device regulations were released by the EEC: Regulation 144, a revision of EEU rules for device registration and examination (link in Russian), and regulation 146, a new edition of the guidance on clinical trials (link in Russian).

At the end of January 2022 there  still  7 medical device approved on the Eurasian database according to new requirements, while the Russian Regulator was saying about hundreds of new submissions per day according to the national requirements for the end of 2021 and more than 31 thousand medical devices approved  on “old approach”.

  1. Upcoming Deadline for submission of clinical monitoring reports in Russia

According to regulation 1113 (link in Russian) that came into force in January 2021, clinical post-market monitoring is now required for class III medical devices and IIB implantable devices registered in Russia afterJanuary 2021. The regulation also states that devices should be continuously monitored, with annual monitoring reports for three years after the approval date. Guidelines for the structure and content of the reports are provided in annex 5 of the regulation.

The deadline for submission of the first reports is 1 February 2022. 

On 21 January 2021, Roszdrvnadzor published a reminder for medical device manufacturers (link in Russian) and clarified the report submission requirements on paper.

3. Extension of the accelerated approval route for medical products for diagnosing and treating COVID-19

In December 2021, the Russian Government released regulation 2250 (link in Russian) and extended until 1 January 2025 the accelerated approval process for COVID-19 diagnostic and treatment products.

According to regulation 430 (link in Russian), more than 400 such medical devices may be approved via the expedited evaluation route with a limited expiration date for a particular batch.

More than 500 existing registration certificates in the national database issued via this route had their validity extended from 1 January 2022 until 1 January 2025;

In January 2022, the Russian regulator confirmed it is possible to submit these registration files using Russian national (but not Eurasian ) criteria. 

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Thank you for following my blog, which aims to provide timely and clear updates on the development of Russian and Eurasian medical device regulations. You may also be interested in my recent article on the Eurasian medical device regulation model, which will be published in the Journal of Medical Device Regulation in February 2022.

Three Things You Should Know about Medical Device Regulations in Russia

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Dear Colleagues, 

Welcome to my monthly review of medical device regulatory changes in Russia and the Eurasian region:

1. New Procedure for Importation of Samples of Medical Devices into Russia

On 30 September 2020, the Russian Ministry of Health published Regulation 661N (link in Russian) and updated the procedure for obtaining an importation permit and importing samples of medical devices for registration in Russia. 

The new regulation will go into effect in January 2021, and unlike the current procedure described in Regulation 7N, the entire new procedure will be completed only in electronic form.

The importation permit is required for bringing in samples of medical devices for preregistration testing. It will be required for any medical device made by a foreign manufacturer, except medical software. It will be issued free of charge by the regulator Roszdravnadzor within five business days and will be valid for one year.

The Regulation lists the documents required for obtaining an importation permit and the list of reasons for the rejection of a submission.

2. Updated Guidance on VAT Application for Medical Devices in Russia

On 19 October 2020, the Russian Ministry of Finance published letter N0307-07/90841 (link in Russian) and provided guidance on the application of value-added tax (VAT) exemption on the sale of medical devices and its components in Russia.

According to the document, exemption from VAT is applied on the conditions that there are registration certificates for the medical devices and that they are included in the list found in Resolution 1042.

If the components necessary for the intended use are sold together with medical devices and in the amount specified in the delivery set, then these components should be recognised as integral parts of medical devices and exempted from VAT.



3. Criteria for Humanitarian Use of Medical Products in Kazakhstan

On 14 October 2020, the government of Kazakhstan published Resolution 662 (link in Russian) and updated the list of cases when pharmaceutical products or medical devices are allowed to be imported into the country for humanitarian use.

The regulation allows importation – without the approval/registration by the Ministry of Health – of medical products for the prevention and elimination of the consequences of natural and civil emergencies, as well as during the start of a state of emergency; of medical products that are intended for prevention and treatment of especially dangerous infectious diseases; and of orphan (rare) diseases.

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union – August 2020

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Welcome to my monthly review of the most important updates to medical device regulations in Russia and the Eurasian countries.

 

  1. Development of the Regulations for Software as a Medical Device (SaMD) and Artificial Intelligence

On the 10th August 2020, the Russian Ministry of Health published order #686N (link in Russian) and updated the algorithm for the classification and registration of SaMD.

In addition, in early August 2020, the Russian Ministry of Health published two draft regulations:

  • An amendment to the rules governing the state registration of medical devices (link in Russian) suggesting an accelerated approval process (a one-step registration instead of the current two-step process) for SaMD, including software that uses ‘artificial intelligence technologies’.
  • An amendment to the requirements for technical files and the instructions for their use (link in Russian), providing specific requirements in relation to the technical files for SaMD.

It is interesting to mention that at the end of July 2020, the Russian Ministry of Health announced that work to improve the standards of artificial intelligence in healthcare was underway, and in the last month it has been revealed that a first draftof the national standard on clinical trials for systems with artificial intelligence has been published.

Regular readers might also recall that in June 2020, the Russian healthcare regulator Roszdravnadzor published the updated guidelines (national methodical recommendations) for the registration of SaMD in Russia (link in Russian).

The accelerated approval process for the registration of low-risk medical devices (class I) and in vitro diagnostics was implemented in Russia in 2018.

  1. List of Medical Devices Containing Ethyl Alcohol

On the 26th August 2020, Roszdravnadzor published (link in Russian) a list of 41 medical devices containing ethyl alcohol that are excluded from general alcohol regulations in Russia, such as Federal Law 171. The production, importation and circulation of these products will not be covered by the federal law on the regulation of ethyl alcohol and thus will not require additional licenses or permits.

According to the current procedure, this list is created using applications from manufacturers, or their authorized representatives, submitted to Roszdravnadzor between the 1st of January and the 30th of June each year, and subject to rules that came into effect in 2019.

It should also be noted that Russian legislation specifies that any medical device in liquid form containing ethyl alcohol (ethanol) should be subject to additional specific regulation.

  1. Eurasian Update

On the 3rd August 2020, the Eurasian Commission published a draft regulation with an amendment to the rules for toxicology (biocompatibility) testing of medical devices for Eurasian registration (link to the draft in Russian).

This document included updates to the testing requirements and the description of the testing procedure. The regulation also updated the criteria for the inclusion of testing laboratories into the unified Eurasian database.

For the end of August 2020, according to the official website of the Eurasian Commission, there were three medical devices approved using the Eurasian procedure with more than 20 applications for Eurasian registration submitted by manufacturers over the last year, and 23 laboratories now accredited to perform the testing.

 

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Thank you for following my blog, which is a non-commercial project with the aim of providing timely and clear updates on the development of Russian and Eurasian medical device regulations. Let me remind you that you can receive my regular updates directly to your email via the ‘follow’ button on the toolbar of this blog.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, April 2019

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Dear colleagues,

This is my usual selection of highlights on the changes made to the medical device regulations and trends across Russia and the Eurasian Union over the last month:

 

  1. Some updates on the Eurasian Medical Device Regulations

On 19 April 2019, the Eurasian Commission published Regulation No. 62 ‘On the classification of the areas of intended use for medical devices’ (link in Russian). This third-level regulation document provides a classification system for the intended use of the medical devices that should be used by the applicant in the preparation of documents for the registration dossier.

Earlier, on 3 April 2019, the Eurasian Economic Commission (EEC) published a draft decision ‘On the rules for assessing and authorizing inspecting organizations to conduct QMS inspections.’ (Link in Russian)

According to the official comment in the published document, the EEC does not support the approach proposed earlier, whereby only government bodies can act as inspecting organisations. The proposed draft document contains the requirements and criteria for the QMS inspection organisations, a description of its accreditation procedure (45 days), as well as the subsequent scheduled and unscheduled government audits (at least once over a two-year period).

It should be recalled that on 16 March 2019, it was the end of the transition period which provided manufacturers with a delay in conducting QMS inspections for Eurasian registration.

 

 

  1. The Russian regulator announced a decrease in the number of registration refusals in 2018

On 26 April 2019, the Russian healthcare regulator, Roszdravnadzor, published a video with its annual report for the year 2018. It cites a 38% decrease in the number of registration rejections during last year when compared to the year 2017: 1342 new medical devices were approved and 398 registration applications were rejected in 2018.

rzn-registrations-2018.png

 

Screenshot from the Roszdravnadzor  annual report 2018 shows 38% decrease in number of medical device registration refusals compared to previous year : http://www.roszdravnadzor.ru/news/16631

 

In addition, the regulator announced its priorities for regulations concerning medical devices in 2019 as being: an introduction of the unified database of patients with implanted medical devices; the development of labelling approaches for medical devices; and the organisation and carrying out of activities to inspect the manufacturers of medical devices according to the Eurasian regulation model.

 

  1. Kazakhstan has amended the requirements for inspections

On 10 April 2019, the government of Kazakhstan published the order No. ДР DSM-26 ‘On Approval of the Rules for Inspection in the Sphere of Circulation of Medicinal Products, and Medical Equipment’ (Link in Russian). The document updates the previously established rules and requirements for conducting inspections of manufacturers of pharmaceutical products and medical devices in accordance with Kazakh legislation.

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Thank you for following my blog; it is a non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer. You are able to receive updates directly to your email via the ‘Follow’ button on the toolbar.

Russian and Eurasian Medical Device Regulatory Recap 2018

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Dear colleagues,

In my December newsletter I would like to summarise all the major changes in medical device regulations and trends in Russia over the past year. So here are the top stories you should know in 2018 if you deal with medical devices in Russia.

  1. The development of the Eurasian medical device regulation model has been the most important topic for several years now.

    In March 2018, the last «second level» regulation, #106, of the Eurasian Economic Commission (EEC) on the requirements for the quality management system (QMS) for manufacturers of medical devices for the Eurasian Economic Union (EAEU) registration procedure (link in Russian) came into force and was postponed for one year to allow for a transition period. These requirements were developed on the basis of international standard ISO 13485; however, the audits will be based on compliance with the requirements of the EAEU QMS regulation but not with the requirements of the ISO standard itself.

    Over the year 2018 the EEC released multiple «third level» medical device regulations:

    -Recommendations with criteria for interpreting whether or not a borderline product would be considered a medical device within EAEU regulations (link to the document in Russian).

    – Regulation #116 (link in Russian) provides definitions, algorithms, and criteria for the registration of the spare parts, elements, modifications, components, and consumable materials for medical devices in the EAEU.

    – Regulation #123 (link in Russian) provides criteria for inclusion (grouping) for registration for several modifications to a medical device in one certificate.

    – Methodical guidelines exist for medical device registration expertise for EAEU registration (link in Russian).

    – Regulation #25 concerns the criteria for classifying products as medical devices in the EAU (link in Russian).

    – Regulation #176 concerns the single register of organisations conducting testing/trials for medical devices for registration in the EAEU (link in Russian).

    – Regulation #177 provides a single database on the safety monitoring of medical devices in the EAEU (link in Russian).

    English translations of most Eurasian medical device documents are available on the official EEC website.

    In November 2018, the EEC announced that the first applications to register medical devices under the EAEU medical device system have been filed for review by the competent authorities in Kazakhstan and Russia.

    Over the last year there has been a great deal of discussion on the level of competency of the competent authorities and in the media about potential prolongation of the transition period for the EAEU medical device registration system. There is a draft document available for the end of the year 2018, but no official position has been released on this topic and the end of the transition period remains as 31 December 2021.

  2. Changes and initiatives in the local regulatory systems in Russia and Kazakstan occurred over the year 2018 in parallel with the development of the EAEU medical device system.

    – In June 2018, the Russian government released Resolution # 633 (link in Russian) and simplified the registration process for in-vitro diagnostics in Russia, implementing a one-step assessment process (instead of a two-step process, as previously followed) for all classes of IVDs, which has shortened the overall approval process for IVDs by up to several months.

    – Likewise, Resolution # 633 (link in Russian) implements improvements for the registration of medical devices with a pharmaceutical component (which was considered a significant roadblock in the approval of such medical devices in Russia) before.

    – Another important initiative for Russia (which has not been approved by the end of 2018) is to suggest an expansion of the list of cases when clinical trials involving human subjects are required for the approval of medical devices. The draft document published in May 2018 introduces a requirement for all medical devices  IIB and III classes to undergo mandatory clinical trials involving human subjects, which should be conducted in at least two medical organisations following a single clinical trials protocol.

    – In August 2018, the Ministry of Health of Kazakhstan implemented multiple amendments to the rules for examining (expertise) medicines and medical devices.The published order, #347, (link in Russian) provides the updated requirements for the content of the registration dossier, samples for testing, the procedure for conducting the examination for the registration, and harmonising of the major part of the Kazakh and Eurasian algorithms and requirements for assessment.

  1. Russia chairs the IMDRF in 2019

In conclusion, it should be especially highlighted that in 2019 Russia will be the chairman of the IMDRF and the next two meetings of the IMDRF will be held in Russia: in March 2019 in Moscow and in September 2019 in Yekaterinburg.
The key topics for the meetings for the next year were highlighted as cybersecurity, premarket reviews, and personalised device regulatory pathways.

***
This was the Russian medical device regulatory landscape in 2018.
I would like to thank everyone for following, supporting, and contributing to this blog, my non-commercial project to make Russian and Eurasian medical device regulations clearer for regulatory professionals worldwide.
I would like to wish you a wonderful holiday season!

See you in 2019; there are many exiting things to come.

Alexey Stepanov

Alexey@medicaldevicesinrussia.com

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union in November 2018

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Dear Colleagues,

Welcome to my monthly review of updates on the medical device regulations landscape in Russia and the Eurasian Union for November 2018:

 

  1. First Registration Files for Eurasian Medical Device Registration Procedures and other Eurasian Medical Device Regulations Updates

“The first applications for registration under the Eurasian Economic Union (EAU) medical device system have been filed for review by competent authorities of Kazakhstan and Russia.” It was announced by the Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission (EEC) in Moscow at a conference organized on 15 November 2018 in Moscow by the medical device manufacturers association IMEDA together with the European Association MedTech Europe and EEC. During the same event it was announced that the unified information system for registration of medical devices  will be launched “in full mode” by the end of this year. Unreadiness of this system was, until now, considered as one of the main barriers to starting registration procedures for the harmonized market.

In addition, on 16 November 2018, the EEC published approved versions of several third-level documents:

  • Regulation # 25 – On criteria for classifying products as medical devices in the EAU (link in Russian);
  • Regulation #176 – On the single register of organizations conducting testing/trials of medical devices for registration in the EAU (link in Russian);
  • Regulation #177 – On the single database on safety monitoring of medical devices in the EAU ( link in Russian);

Earlier in November, the EEC published English translations of all second-level Eurasian medical device documents. The link is available on the official EEC website.

 

  1. Clarification on Valued Added Tax (VAT) for Medical Devices

On 2 November 2018, The Russian Ministry of Finance published a clarification letter (link in Russian) on exemption from VAT for the importation and sale of medical devices in the Russian Federation.

According to the letter, medical devices imported and sold in Russia are exempt from VAT if two conditions are met: the first is the presence of a registration certificate for the medical device, and the second is the inclusion of the product in the list of devices, approved by government resolution No. 1042 of 30 September 2015.

 

  1. Update of some Medical Device National Standards in Russia

 It is important and often critical to use the most updated version of the national standards for the preparation of the technical documentation, testing, and assessment of medical devices in Russia. Several GOST standards relevant for registration of medical devices in Russia will be updated within the next two months.

Thus, on 1 January 2019 the new versions of the following national standards will come into force:

  • Sterilization of health care products. Moist heat (Part 3). Guidance on the designation of a medical device to a product family and processing category for steam sterilization (link in Russian);
  • Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 (link in Russian);
  • Medical devices utilizing animal tissues and their derivatives (link in Russian);

On 1 February 2019 the following national standards will also come into force:

  • Medical electrical equipment. Part 2-49. Particular requirements for the basic safety and essential performance of multi-functional patient monitoring equipment (link in Russian)

 

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Thank you for following my blog, which is a non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer for regulatory professionals. You can also follow my updates on Twitter @Meddevrus.

 

 

Russia Released Multiple Changes in Medical Device and IVD Registration Requirements

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It’s a quite a good news for IVD manufacturers… In the first days of June 2018, the Russian Government released the resolution #633 (link in Russian) and approved significant multiple changes in the procedure of registration of medical devices in Russia:

  • Simplification of the registration process of in-vitro diagnostics (IVD) proposing one-step expert assessment (expertise) for registration instead of the current two-step pathway. All classes IVDs pass henceforward through simplified registration process by analogy with class I and non-sterile class IIa medical devices;
  • Significant changes for the list of reasons, requirements and timelines for regulatory renewals (amendments of the registration certificates and amendments of documents of the registration dossier) for already registered devices; the list of cases when expert assessment (expertise) is not required for re-registration was clarified;
  • Update of requirements for documents of registration file for IVDs and medical devices with pharmaceutical component;
  • Extension of the list of reason for registration rejection and cases when registration certificate may be withdrawn/annulled;
  • Other minor amendments on registration procedure e.g. requirement of providing information of trademark, clarification of number of possible additional document requests from the assessment body and clarification of administrative requirements for the applicant…

Overall,  the amendments of the resolution #633 harmonise Russian medical device registration requirements with Eurasian regulations and aimed to simplify IVD and MD approval process.