Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, September 2018

 

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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Three Things You Should Know about Medical Device Regulations in Russia, November 2017

Dear colleagues and group members,

Welcome to my monthly newsletter with the most important regulatory updates on medical devices in Russia for November 2017.

  1. Russian medical device expert organisations are starting pre-submission consultancy
    In November 2017, both Russian expert organisations involved in the registration process announced the start of pre-submission consultations for medical device manufacturers. The expert organisations published information on consultancy procedures, application forms, contracts, information on prices, and required and recommended documents on their websites:
    – Consultations from VNIIMT (ВНИИМТ) expert organization – link in Russian;
    – Consultations from CMIKEE (ЦМИКЭЭ) expert organization – link in Russian;

    According to Roszdravnadzor Regulation 6478 (link in Russian) published in July and enforced in September 2017, the scope of the consultations are: development of a medical device and necessary documentation and testing for registration and re-registration for particular devices, specific aspects of the Russian registration process and requirements, classification of medical devices, and determination if a product meets the definition of a medical device, according to Russian regulations.

  2. Evolution of restrictions on polyvinyl chloride consumables
    On 1 November 2017, the Russian Ministry of Health published a letter (link in Russian) with information on weighted average prices for disposable medical devices from the government list of foreign disposables made from polyvinyl chloride (PVC) plastics, whose admission to public procurement was restricted by Resolution # 968.
    It should be recalled that Resolution No. 967 (link in Russian) and Resolution No. 968 (link in Russian) came into force in August 2017, and extended the list of medical products restricted from participation in state procurements, (link to up-to-date version in Russian) with particular reference to medical devices containing PVC implementing criteria for its manufacturers, and the new scheme of state procurement for such products.
    The national register for manufacturers of PVC consumables that met the criteria is published by the Russian Ministry of Industry and Trade and at the end of November contains one company.

    3. Medical software in telemedicine technologies

    On 3 November 2017, the Russian Ministry of Health published draft regulations on providing medical care using telemedicine technologies (link in Russian). Amongst other matters, the document contains a requirement for mandatory registration of special medical software that is ‘designed for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body and used as a part of information systems’ as a medical device.

    It should be noted that, the Russian medical device regulator Roszdravnadzor has emphasised several times during the past years that medical software should be considered a type of medical device and must therefore pass the mandatory registration process

Three Things You Should Know about Medical Device Regulations in Russia, January 2016

Dear Colleagues,

It is the end of the January and I am glad to deliver my monthly update on events in the Russian and Eurasian regulatory landscape.

  1. The Eurasian Market for Medical Devices Formally Came into Force

On 1 January 2016, Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan formally introduced a common market and regulatory system for medical devices within the Eurasian Economic Union (EEU). One of the final steps – ratification by Russian parliament – was completed by the end of January. Some (but not all) second-level regulations have now been officially published and are in force: e.g. new rules on post-market safety surveillance can be found on the website of Roszdravnadzor (the Russian medical device regulator).

From a practical standpoint, there is currently no information about how any regulatory step (testing, expertize, clinical trials, registration submission) should be conducted under the new Eurasian approach, and medical device competent authorities in member states continue to receive registration submissions and grant approvals using “old” local procedures. From 1-28 of January 2016, for instance, 166 medical device approvals were registered in the database of the competent authority in Russia, while 87 approvals were made in Kazakhstan and 149 in Belarus.

Roszdravnadzor has announced a full-day regulatory conference (with online broadcast) on 4 February 2016, where more details and guidance about Eurasian medical device integration are expected to be announced.

 

  1. Evolution of Price Regulation for Implantable Medical Devices in Russia

The subjects of price regulation for implantable medical devices and “destabilization of prices in the market” for state procurements have been discussed by Russian government institutions since the end of 2014, when the Russian Ministry of Health published a list of “implantable medical devices approved for state programmes of guarantees on gratuitous medical care”.
In March 2015, Russia adopted amendments to Article #80 of Federal Law No. 323-FZ (“On fundamental healthcare principles in the Russian Federation”) and introduced regulation of maximum sale prices and maximum volume of wholesale and retail mark-ups for medical devices on the previously published list.
On 9 January 2016, the Russian government published Resolution #1517 (link in Russian), titled “On state regulations of prices of medical devices included in the list”. The resolution came into force on 16 January 2016 and set the methodology for how mark-ups on such devices should be calculated. According to the resolution, prices in future state procurement contracts for implantable medical devices on the list cannot exceed the stated values, including after maximum mark-ups and valued added tax have been calculated accordingly.
In addition, the resolution set a deadline of 15 July 2016 for manufacturers or Russian-authorized representatives to submit files to Roszdravnadzor for price registration.

 

  1. Roszdravnadzor on Medical Software

Roszdravnadzor clarified its requirements for medical software. According to the letter released at the beginning of January (link in Russian), the Russian medical device regulator has informed manufacturers that medical software should be considered a type of medical device and must therefore pass the mandatory registration process if it has any of the following uses: operation of medical equipment, receiving diagnostic data, monitoring and transmitting information on bodily functions (including wireless technologies), calculating dosages for medicines or emissions, medical data management, medical image processing, 3D modelling, or connection of medical and diagnostic equipment. Medical software in Russia, like in many jurisdictions, can be registered as a standalone unit or an integrated part of a medical device.

 

To conclude, I would like to remind that you can follow my updates about Russian medical device regulations on twitter @MedDevRus or get them directly via e-mail using the “Follow” button on the toolbar of this page.

Alexey Stepanov
Alexey@medicaldevicesinrussia.com

Five Questions about Medical Software Regulations in Russia

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  1. Should medical software be registered in Russia?
    Yes, according to clause #2 of Russian medical device registration rules (Decree 1416, link in Russian), special medical software is covered by the definition of a medical device and must be registered prior to market access.
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  1. Should medical software be registered in a separate registration certificate or together with another device for which it is intended?
    Roszdravnadzor (Russian medical device regulator) did not provide clear guidelines on this point up to now. However, if you undertake some brief research in the state medical device register (Roszdravnadzor`s national database of approved medical devices), it is apparent that, since new registration rules were enforced in January 2013, medical software was mentioned in 258 Russian registration certificates. Of this number, absolutely the major part of software was registered as a component or as an accessory to other medical devices (e.g. computerised tomography systems, ultrasound and X-ray devices…). I could find only four cases since this period when medical software was registered as a separate medical product (separate registration certificate).
    It should be noted that, since the beginning of 2015, a new medical device nomenclature classifier has been enforced. In the current version of this classification there are more than 150 codes devoted to medical software depending on its intended use.
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  2. Should a version of software be indicated in the registration submission?
    Roszdravnadzor recommends including the name and the version of the software in the registration application form. Even if medical software is submitted for registration together or as a part of another medical device, its version and release date should be mentioned in the technical file in the registration dossier.  If several versions are mentioned in the description of a medical device, each modification of software should be identified by name, version and release date. Based on recent feedback from the Russian regulator, lack of detailed identification of software is a typical and one of the most common reasons for additional requests and delays during registration expertise in the last year.
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  3. What should be done if the software has been upgraded after a product is registered?
    Upgrade of the software requires notification of Roszdravnadzor (see clause #55 of Decree 1416, link in Russian ). After this notification, then regulator will make a decision; if such an upgrade requires identification of a new software version and if a procedure of revision/renewal of technical documentation of a medical device is necessary. Usually, minor changes and bug fixes will not require further regulatory actions after the notification.
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  4. What are the main regulations?
    -Russian National Standard GOST R ISO/MEC 12119:2000 (link in Russian)
    -Federal Law 102-FZ dated 26.06.2008 (clauses 3.2 and 4.2.5) (link in Russian)
    -WELMEC 7.2 Issue 4 (measuring Instrument Directive 2004/22/EC)