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Three Things You Should Know About Medical Device Regulations in Russia – August 2019

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Dear Colleagues,

August was rather quiet in Russia and the Eurasian countries in terms of new medical device regulations released. Nevertheless, for those of you interested in the field, here is the usual selection of my monthly highlights:

 

  1. Extension of the List of Medical Devices with 0% VAT in Russia

On 19 August 2019 the Russian government published resolution no. 1054 (Link in Russian) and extended the list of medical devices which are not subject to VAT.
It should be recalled that the list was launched in 2015; however, since January 2017, when a new OKPD2 (ОКПД-2) classification came into force in Russia, a significant number of new codes for medical devices, such as certain surgical instruments, computer tomography, certain diagnostic devices, X-ray and ultrasound machines, and electro-diagnostic and scintigraphic devices, were missing from the list. As implemented by Russian tax regulations, the VAT for these products was changed from 0% to 18%. This has led to difficulties with their importation and tax/customs clearance for their distributors and manufacturers.
The updated list uses a new classification system and includes more than 90 new (OKPD-2) codes for medical devices previously missing codes. It also provides VAT preferences for ‘old’ (OKP) codes for medical devices registered before 2017.

 

  1. IMDRF Meeting in Yekaterinburg

In 2019 Russia is the official chair of the International Medical Device Regulators Forum (IMDRF). The sixteenth IMDRF meeting and Open Stakeholders Forum will be held from 16-19 September 2019 in Yekaterinburg. The meeting’s key topic has been announced as artificial intelligence in healthcare and the meeting will address regulatory and standardisation activities for medical devices based on artificial intelligence. A detailed agenda is published on the official webpage of the event. Registration is open until 9 September 2019.
It should also be noted that the Russian healthcare regulator Roszdravnadzor announced an internal IVD working group meeting taking place from 20-22 August 2019 within the framework of the IMDRF forum.
The previous IMDRF meeting took place in Moscow in March 2019.

  1. Update on Notification Requirements on the Start of Activities in the Medical Device Domain

On 9 August 2019 the Russian Ministry of Health enforced Order 3239 (link in Russian) with a new edition of the regulation on notifications on the start of activities in the field of circulation of medical devices. According to the enforced document, any legal entity involved in medical device circulation in Russia must notify healthcare regulators prior to the start of activities. The requirement is not new, but a new edition of the regulations harmonised it with other regulations and allows for the submitting of notifications to any territorial body of Roszdravnadzor in Russia.

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

Three Things You Should Know about Medical Device Regulations in Russia, March 2019:

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Dear fellow colleagues,

 

This is my usual newsletter with a selection of updates regarding the medical device regulation landscape in Russia and the Eurasian Union for the last month.

 

  1. International Medical Device Regulators Forum in Moscow

    IMDRF.jpg

The 15th International Medical Device Regulators Forum (IMDRF) and Open Stakeholders Forum were held from 19–21 March 2019 in Moscow. Here are some of the most important outcomes from the event:

The Russian healthcare regulator Roszdravnadzor reported about preparation at the conclusion of the Forum with regard to final versions of the following documents, which are “in process of implementation as part of the Russian regulation system”:

  • ‘Principles of labelling of medical devices, including medical devices for in vitro diagnostics’;
  • ‘Guidelines for the application of the system of unique identification of medical devices UDI’;
  • ‘Terminology of adverse events: terms, structure, codes; Appendix E, F’;
  • ‘Electronic registration for medical devices (IVD & non IVD)’;

On 20 March 2019 the IMDRF issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents explaining how to build submissions using its table of contents structure.

Moreover, ahead of the Forum on 18th March 2019 the Global Medical Device Nomenclature (GMDN) Agency signed a Memorandum of Cooperation with the Eurasian Economic Commission to enable it to use the GMDN to support the improved identification and regulation within the Eurasian medical device regulatory system.

The next meeting of the IMDRF Leadership Committee is planned for 16–19 September 2019 in Yekaterinburg.

 

  1. Russia is Discussing a Potential New Regulatory Path for the Scientific Application of IVDs

On 27 February 2019, the Russian Ministry of Health published a draft federal law (link in Russian) suggesting a potential new regulatory path for some in vitro diagnostics (IVDs) in Russia.

Thus, according to the document, IVDs that are developed, manufactured and applied in the laboratories or medical organisations engaged in scientific activity, may be allowed for use without registration upon condition that special five-year permits are obtained by the said medical/scientific organisation and the IVD product is included in the special register after the assessment procedure (expertise).

The draft document also describes control measures and algorithms of safety monitoring for such IVDs and the requirements for the medical/scientific laboratories that apply such products.

It should be noted that the registration procedure for all IVDs in Russia was simplified in June 2018; however, even today it still remains quite a long and complex process.

 

  1. New Version of the List of Medical Devices with Reduced VAT

On 15 March 2019, the Russian Ministry of Health published a revised version of the draft amendments to the list of medical devices exempted from VAT (link in Russian).

It should be recalled, that a single list of medical devices with a reduced VAT rate was approved by the Russian government in the Resolution 1042 in September 2015; however, since January 2017, after the entry into force of the new Russian classification system some of the medical devices (for example, some cardiac pacemakers, computer tomography, electrocardiography, and pieces of ultrasound and laser equipment) on the list were changed into categories that in practice do not have tax preferences. The published draft with a new version of the list based on a new classification system contains new codes and is intended to remedy this situation.

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

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Dear colleagues,

This is my short selection of highlights on medical device regulation changes and trends across Russia and the Eurasian Union for the last month:

 

  1. Medical Device Identification Requirement Initiative in Russia

The Russian law No. 488 (link in Russian), enforced in December 2018, gave the Russian government the right to approve the lists of goods subject to mandatory labelling/marking with additional means of identification. The objective of this initiative is to counteract the turnover of counterfeit products on the market.
Before 2019, the product labelling/marking initiative worked in experimental mode involving fur products (since 2016), medical drugs (since February 2017), and alcohol and tobacco products (since 2018). This year, Russia is also planning to gradually introduce the requirement of mandatory identification labelling/marking on other types of goods.

On 7 February 2019, the Russian medical device regulator Roszdravnadzor reported that the draft document on mandatory marking of medical devices has been prepared by the regulator and will be published in the near future. According to the regulator, the new requirements have been prepared ‘in line with the latest international requirements and on analogy with UDI’ in order to ensure traceability and to adequately identify medical devices through their distribution and use in Russia.


  1. Multiple Changes in Medical Device Regulations in     Kyrgyzstan

On 14 February 2019, the decree No. 311 of the Government of Kyrgyzstan ‘On certain aspects related to the registration of medical devices’ (link in Russian) came into force and introduced multiple changes in the medical device regulation in the country.

Thus, new local medical device registration rules (link in Russian) were implemented. According to the new rules, the medical device registration process takes up to 90 days and consists of a two-step examination: analytical expertise (this step is not required for medical devices approved in the European Union, Australia, Canada, Japan and USA) and specialised expertise completed with manufacturing site inspections in some cases.

In addition to the new registration rules, the enforced decree No. 311 accepts that classification of medical devices, as well as technical, biocompatibility testing and clinical trials for local registration, are conducted according to enforced Eurasian regulations.

Kyrgyzstan is a full-fledged member of the Eurasian Economic Union since 2015.

  1. IMDRF Meeting in Moscow

The fifteenth meeting of the International Forum of Regulators of Medical Devices (IMDRF), chaired by the Russian Federation, will take place on 18-21 March 2019 in Moscow for delegates from the medical devices manufacturing industry, research institutions, federal executive authorities, state institutions, foreign and international regulatory organisations. The open stakeholders forum will be held on 19 March 2019, with an agenda and registration details available on the IMDRF website and on the official web page of the event.

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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.

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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, September 2018

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Dear Colleagues,

Here is my usual monthly selection of news about developments in medical device regulations in Russia and countries of the Eurasian Economic Union for September 2018.

  1. Kazakhstan Changes the Rules for Registration Examination of Medical Devices

At the end of August 2018, order #347 of the Ministry of Health of Kazakhstan (link in Russian) came into force and implemented multiple amendments to the rules of examination (expertise) of medicines and medical devices for registration according to the local procedure. 

Order #347 provides updated requirements for the content of the registration dossier, samples for testing, and the procedure for conducting the examination for registration. The expertise process for registration of medical devices consists, as before, of three steps (validation of the registration documents, laboratory testing, and specialised expertise), which take up to 90 working days of real time for I and IIA class devices and up to 160 working days for IIb–III class devices.
In the new edition of the rules, we notice the harmonisation of the major part of the Kazakh and Eurasian algorithms and requirements for assessment.
The new rules also stipulate the possibility of obtaining pre-registration consultancy from the expert organisation.
New requirements have been effective for all medical device submissions for registration and renewals in Kazakhstan since early September 2018.

  1. Russia: Guidelines on Software Registration

On 12 September 2018, Russian medical device regulator Roszdravnadzor published methodological recommendations (guidelines) on the procedure for assessment (expertise) of medical software for its registration as a medical device in Russia (link to the document in Russian).
The published document is intended to establish uniform approaches for the registration assessment of software as a  stand-alone medical device across institutions involved in the medical device registration process in Russia.
The guidelines contain a list of criteria for assigning software to medical devices depending on their intended use, principles for classification and determining the risk category, possible criteria for non-compliance during registration assessment, algorithms for assessment of technical documentation, and a list of national standards used for software evaluation.

  1. Russia to Chair IMDRF in 2019

Russia will replace China as IMDRF (International Medical Device Regulators Forum) chair in 2019; this was announced during the IMDRF meeting in Beijing, China where  the key topics for the next year were highlighted as Cybersecurity, Premarket Reviews, Personalized Device Regulatory Pathways. The upcoming IMDRF meeting in March 2019 was also announced by the Roszdravnadzor management during the industry meeting in September 2018.

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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. You can receive updates directly to your e-mail via the ‘Follow’ button on the toolbar.