Category Archives: English

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)

Three Things You Should Know about Medical Device Regulations in Russia and CIS, June 2015

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Dear Regulatory Colleagues,

Please find below my monthly update of important news on medical device regulations in Russia and the CIS region:

1.Ukraine: The Transformation of the Medical Device Regulatory System – Will it be Painful for the Industry?

1 July 2015 is the enforcement date for the new medical device approval procedures in Ukraine. After this, new products will only be able to access the Ukrainian market by conforming to assessment procedures similar to those used by the European regulatory model. The Ukrainian Ministry of Health should promptly adopt additional regulations for the transition to the new regulatory system. It should be remembered that the introduction of new regulations has already been postponed three times in the last several years. Industry players consistently express fears about a possible crisis in the medical device sector in the country due to incomplete legislation covering the transitional period. Another concern of local trade associations is the introduction of mandatory inspection for foreign medical device manufacturers as a part of the assessment procedures for certain types of device. This has a high probability of causing extra delays in market approval due to the lack of qualified inspectors.

2. Russia: Revised Standards on Clinical Trials

A new Russian national standard (GOST ISO 14155-2014 “Clinical trials: Good Clinical Practice” – link in Russian) came into force on 1 June 2015 and replaced the previously enacted GOST R ISO 14155-1-2008 and GOST R ISO 14155-2-2008 standards. This standard has been designed to harmonize with the similar international standard ISO 14155: 2011, which addresses planning, documentation and proper representation of the results of clinical trials to ensure the validity of the data, as well as to protect the rights, safety and well-being of human subjects and define the responsibility of sponsors. It should be highlighted that this standard is highly recommended by Roszdravnadzor (Russian medical device regulator) for clinical trials related to the registration of medical devices in Russia, and it is not applicable to in-vitro diagnostic devices.

3.Eurasian Union: Draft of Harmonized Technical Testing Rules

As is commonly known, the requirements of the technical testing (a form of conformity assessment) for medical devices, as well as requirements for laboratory accreditation, currently differ between Russia, Belarus and Kazakhstan. This means that the results of tests conducted in any one of these countries are not recognized or accepted in the others. On 22 June 2015 the Eurasian commission published a draft of harmonized rules (link in Russian) for technical testing of medical devices, establishing common requirements for technical test procedures across the Eurasian Economic Union (EEU). This document is a second-level guideline which (together with other second level regulations) complement the agreement on the common principles of the circulation of medical devices (link in Russian), which are expected to come into force on 1 January 2016 and thenceforth govern a common market for medical devices in the EEU.

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As usual, I would also like to remind you that the objective of this blog is to make Russian and Eurasian medical device regulations clearer. I therefore encourage you to post your comments and questions either here or on the Russian medical device regulations LinkedIn group.

Three Things You Should Know about Medical Device Regulations in Russia and CIS, May 2015

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Dear Colleagues,

I hope your Russian regulatory projects are going well! Let me deliver my monthly update of the most important regulatory news for Russia, CIS and the Eurasian Customs Union:

  1. Ukraine: should current medical device registration certificates be renewed?

1 July 2015 is the enforcement date for the new medical device approval procedures in Ukraine. After this date, the access of new products to the Ukrainian market is expected to be possible only by obtaining a special mark, achieved by conformity with the new technical regulations such as:
-technical regulation #753 –        Medical devices (link in Russian)
-technical regulation #754 –        In vitro diagnostic devices (link in Russian)
-technical regulation #755 –        Active implantable medical devices (link in Russian)
The deadlines for mandatory application of technical regulations has been repeatedly postponed since  2011, but according to the message from the Ukrainian Ministry of Health, this year the Regulator is going to adhere firmly to the announced date and does not recommended another postponement.
Last month the Ukrainian government approved decree №181 (link in Russian), which establishes a procedure for the transitional period until 1 July 2015. After 1 July 2015, the admission of products already registered in Ukraine is expected to be permitted until 1 July 2016 or until the expiration date of the relevant product’s registration (if this date is earlier than 1 July 2016).
Meanwhile, Ukraine has recently established a temporary exemption from VAT and fast track registration for certain medical devices imported and/or supplied on the basis of agreements with qualified international procurement agencies.

  1. Strengthening price regulation for implantable devices in Russia

Amendments to the Federal Healthcare Act (link in Russian), signed in February, are aimed at strengthening the regulation of prices for implantable medical devices. These amendments officially came into force on 9 May 2015. These amendments have introduced price registration, monitoring and control for implantable medical devices included in the list of implantable medical devices subject for national reimbursement programmes.  Despite the fact that these amendments are now in force, the law is not yet effective due to a lack of secondary legislation (i.e. a description of  the price registration procedure and  methodology for determining the maximum wholesale producer’s prices for medical devices) which are at the stage of approval and are expected within the coming weeks.

  1. Status of the Eurasian Medical Device Harmonisation

At the meetings of the working group of the Eurasian Economic Union (13-15 May 2015 in Almay (Kazakhstan)) it was confirmed that there may be a “high degree of readiness” of a major part of second-level regulations for common medical device regulations, which is expected to come into force on 1 January 2016. The draft rules of registration and expertise of medical devices proposed previously by Kazak regulators as well as the requirements for its implementation maintain the quality management system for medical device manufacturers are approved with some additional recommendations.  Documents will be available on the official website. For now, three guidelines for new medical device systems are already approved and available: 1. classification according to safety class (link in Russian), 2. essential principles of safety and performance (link in Russian) and 3. requirements for EAC mark (link in Russian).

Let me take advantage of this update as well to thank you for following this blog and invite you again to register and to ask your questions in the new Russian Medical Device Internet Forum which you can find at the top of this page //www.medicaldevicesinrussia.com/ or http://meddevrus.listbb.ru

Welcome to Russian Medical Device Regulations Forum

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Dear Fellow Colleagues,
One year ago I decided to launch my blog http://www.medicaldevicesinrussia.com in order to make Russian medical device regulations clearer.

Seeing the discussions on local Russian conferences and professional meeting I thought that we might need such tool as internet forum to share experience and accumulate information and best practices for registration of medical devices in Russia. For many of us forum is easier for navigate and more convenient communication tool.

Some days ago I launched this internet forum and hereby invite you to join, register and to start any discussion. You can find this forum in the top of main page of this blog or via direct link http://meddevrus.listbb.ru

I would like to draw your attention that I made this tool bilingual and there is special English section there.

forum

I would be glad as well for any of your feedback and ideas on this topic.

Three Things You Should Know about Medical Device Regulations in Russia and CIS, April 2015

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As usual at the end of the month, I would like to share my selection of highlights on what is going on with the regulation of medical devices in Russia, the Eurasian Customs Union, and CIS countries:

 

  1. Russia has published a 5-year import substitution strategy.
    The Ministry of Industry and Trade of the Russian Federation (MinPromTorg) approved the 2nd April 2015 strategic 5-year plan for import substitution in the pharmaceutical and medical device industry. Within this plan, there is a list (link in Russian) of one hundred and eleven groups of medical devices detailing targeted market shares of foreign manufacturers by 2020. Among them, for example, are surgical disposable materials (target is 40% imports in 2020, compared to 90% at the moment), prostheses, endoprostheses and their parts, cardio pacemakers (10% import in 2020 vs. 85% now), endoscopes (35% vs. 100%), X-ray equipment, and other groups of medical devices. It is to be noted here that the National program for the development of the pharmaceutical and medical industry approved last year’s target of a 40% market share of all medical devices to be manufactured in Russia by 2020.
  2. Kazakhstan has changed the registration procedures.
    In April, the Ministry of Health of Kazakhstan published changes in order №735 of the registration of medicines and medical devices and medical technique equipment (link in Russian) and order №736 for expertise in pharmaceuticals and medical devices (link in Russian). The relevant authorities in Kazakhstan held a seminar explaining the new rules.
    The main changes in procedure include a requirement of expertise of a medical device prior to a submission for registration and introduction of a mandatory electronic registration dossier.
    From April 2015, all registration documents will only be accepted in electronic form. In the process for expertise and registration, the electronic dossier will be updated with the conclusions of experts at all stages of examination, as well as with additional materials. It should be recalled that Kazakhstan has a separate procedure for medical equipment (technique) and medical devices and requires separate registration for every manufacturing site.
  3. Medical device mark for Eurasian Economic Customs Union.
    In April 2015, the draft ( link in Russian) of a special mark for medical devices marketed in the Eurasian Economic Customs Union (EECU) became available on the website of the Eurasian Economic Commission.Screenshot_1
    It is expected that before the release of a medical device for circulation in the EECU, the manufacturer or their authorised representative will mark the medical device with this mark (the device, individual packing, and instructions for use should be marked), if the device passed the newly established registration procedure. Let me remind you that the agreement on common principles of the circulation of medical devices, signed in December 2014, implies the harmonisation of registration and labelling requirements, circulation, and post-market surveillance for medical devices across Russia, Belarus, and Kazakhstan from the 1st January 2016.

I would also like to use the opportunity of this update to thank all blog readers and group members for following and invite you to join my presentation on upcoming EECU medical device regulations at the Informa Regulatory Affairs in Emerging Markets conference in June 2015.

Russia Medical Device Market Access and ISO 13485 certification for the ROW

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Dear Colleagues,

Let me invite you to a free webinar Russia Medical Device Market Access and ISO 13485 certification for the ROW that I am preparing currently with LNE/G-Med.

The webcast will take place on Wednesday, April 29, 2015 from 2:00 PM to 2:30 PM (US Eastern Daylight Time) and will cover up to date Russian medical device registration steps and regulations as well as ISO 13485’s and CE marking  role in the Russian medical device regulatory system.

You can check an agenda and to register for free on the link below:

http://www.lne-america.com/about-us/eventsappearances.html

Nine Questions about Registration of Medical Devices in Russia

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На русском

“A complex landscape, which is continuing to be adjusted” …this quote, by the head of the medical device expertise body, is a description of what is going on today in the regulation of medical devices in Russia and was the main idea behind ​​the seminar on the registration of medical devices in Russia, held by the medical device regulator on the 6th and 7th of April in Saint-Petersburg. In addition to the official reports of experts, a lot of time at this event was assigned to live discussion, with representatives of Russian and international medical device companies. I would like to highlight below the most interesting of these questions which were answered by the experts:

  1. Question: Is it allowed to group in one registration submission several medical devices of different types according to the Russian nomenclature classification?

    Expert answered: No. It is possible to group medical devices only within one type of nomenclature classifier.  This question is still open for renewals of registrations already granted, and Roszdravnadzor (the Russian medical device regulator) is considering the possibility of listing multiple types of medical devices in the registration certificates issued previously.

  2.  Question: What should I do if the type (code) of my medical device is not listed in the nomenclature classifier?

    Expert answered: Roszdravnadzor is working to keep the national medical device nomenclature classifier updated and harmonized with global medical device nomenclature (GMDN).  If the type (code) of a medical device is not listed in the current version of the classifier, it is recommended to submit the code GMDN for the medical device in the technical file. In this case, the regulator will assign a similar Russian code.

  3. Question: Can I get a formal consultation on the registration process with Roszdravnadzor or an expert organization?

    Expert answered: Currently, Roszdravnadzor does not consult applicants. Any question about the registration of medical devices is only possible in the form of a written request.  It should be noted however, that Roszdravnadzor is currently considering legal mechanisms for the possibility of such consultations in the future.
    Expert organizations also do not provide consultation options for applicants, and they conduct their activities only upon request of Roszdravnadzor. According to the Decree of Ministry of Health number 1353N, direct communication between experts and applicants is prohibited. If the applicant has any query for the expert organization, it should apply to Roszdravnadzor.

  1. Question: Who and how determines if a borderline product (e.g. medical device, pharmaceuticals, biological product) can be registered as a medical device?

    Expert answered: Before the registration of borderline products, this question should be addressed (with a technical file and IFU) to the special interdepartmental commission convened regularly by Roszdravnadzor.
  2. Question: Is Russian registration mandatory for a medical device manufactured in Russia for export sales only?

    Expert answered: Yes. Manufacturing is part of the life-cycle of a medical device; therefore, registration is mandatory in order to start production of any medical device in Russia, even if it is for export purposes only.

 

  1. Who and at what stage of the registration process defines whether a medical device will undergo full clinical trials, or only evaluation of clinical data for the registration?

    Expert answered: After the first stage of the expertise and obtaining the authorization of Roszdravnadzor, the clinical investigation plan, including study design, should be developed by the applicant together with an accredited clinical center. It is an obligation for the applicant to provide an appropriate evidence base in order for the clinical center to make a decision about how clinical data could be obtained.

 

  1. Are there any requirements for the design plan of the clinical trial?

    Expert answered: A program of clinical trials can be drafted in any form and should contain the information required by ISO 14155-2008

  2. Question: How can I perform clinical trials of an analyzer and in-vitro reagents, if these items should be submitted for registration separately?

    Expert answered: Such items should undergo clinical trials and technical testing together. The same rule applies to analytical systems, components of which are registered as individual medical devices (glucometers, test strips, test solutions).

  1. Is clinical usage of a medical device authorized when the registration certificate has expired?Expert answered:

    Yes. According to the explanation of the Ministry of Health, if a medical device was imported into Russia, and purchased by a clinical center during the period of validity of the registration certificate, then such a medical device can be used for clinical purposes until the end of lifetime indicated in the IFU.

Disclaimer: the objective of this post is solely to provide information about the seminar that I found interesting from my professional point of view. This post is NIETHER an official report NOR recommendation and does NOT state official position of any organization or regulatory body.