Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, March 2017.

 

Dear Colleagues and Group Members,

Welcome to my monthly update on the latest news on medical device regulations in Russia and the Eurasian Economic Union. Here are three of the most important updates for March 2017:

 

  1. Russia Released Requirements on Technical Files and Instructions for Use of Medical Devices

 

On 15th March 2017, the Russian Ministry of Health released Order #11N (link in Russian) with a list of requirements for technical files and instructions for use of medical and in-vitro devices (IVD). Undoubtedly, this is one of the most important and long-awaited Orders concerning medical device regulations issued in Russia in the last few years. Since the Russian medical device regulation system changed in 2013, information on the structure of technical documentation was available only as recommendations or voluntary standards, which could be interpreted differently by different institutions. This was one of the most common sources of a lack of understanding of registration requirements and subsequent registration delays.

 

The new requirements became effective from 24th March 2017. Since this date, manufacturers have had to ensure that technical files in registration dossiers for medical devices contain 20 mandatory clauses/chapters (and seven additional clauses for IVD products). Meanwhile the structure of so-called “operational documentation” (i.e. instructions for use (IFU) /product inserts/user manuals) must contain 21 clauses/chapters for all medical devices, with 19 additional clauses for IVD products.

 

As this regulation is relatively recent and no additional guidance has been published, it is difficult to assess the impact at this stage, but it should be noted that some requirements are quite new, for example, one of the requirements for IFU is to provide “the list of data, keys, passwords, and software necessary to mount, set up, operate, and maintain the medical device provided by the manufacturer” (see clause 11g) or to include “the list of national <i.e. Russian?> standards applied by the manufacturer” (see clause 11h).

 

I will closely follow the development of this topic in my blog and publish an analysis of new requirements relating to any additional guidance in future posts of this blog.

 

 

 

  1. Consulting on Russian Medical Device Registration Procedure

 

Following Resolution #160 published last month which (among other initiatives) provided the possibility of official consultations on the medical device registration process on behalf of Russian regulatory expert centres, in March 2017 Roszdravnadzor (the Russian medical device regulator) published the draft regulation with a detailed description of the future consultation procedure. According to the document, consultancy will be performed by two Russian expert organisations involved in the registration process, namely VNIIMT (ВНИИМТ) and CMKEE(ЦМИКЭЭ). Consultations could cover registration and re-registration procedures, question classification of medical devices according to Russian regulations and could be carried out by answering questions posed by applicants, both in oral and written forms.

During consultations, experts cannot perform preliminary assessments of a dossier and cannot cover questions regarding expert evaluation.
A consultancy meeting should be scheduled based on the contract between an applicant and expert centre, and should occur within thirty days of receipt of the applicant`s request for a meeting.

The cost of consulting services and their schedules will be determined by each expert centre.

 

 

 

  1. Reporting Adverse Events in Belarus

 

In March 2017, the Belorussian Ministry of Health clarified its requirements for reporting adverse events for manufacturers of medical devices. According to a letter released on 17th March 2017, the following information must be reported: “serious or unexpected side-effects not mentioned in the instructions for use <of a medical device>, all adverse events during its usage/exploitation, peculiarities of interaction with other medical devices” to include facts of substandard quality and circumstances creating a threat to life and health of patients and medical personnel”. In the same letter, the regulator provided a form for manufacturers or distributors to use for reporting events and warned about responsibility measures in case of potential violations.

 

 

***

My blog is a non-commercial project aimed to make Russian and Eurasian medical device regulations clearer. I would like to remind that you can get my updates directly via e-mail by using the “Follow” button on the toolbar of this page.

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

Dear Colleagues and Group Members,

This is a monthly update with my selection of highlights at the end of January on medical device regulation changes across Russia:

1. Cancellation of “old” forms of Medical Device Registration Certificates.
On 1 January 2017, Russia applied a deadline for the replacement of old forms of registration certificates for medical devices. Despite the fact that this deadline was set and became known four years ago, and the administrative procedure of the replacement was relatively simple (compared to the registration process), several sources have reported a number of cases when medical device companies did not replace their licences in time and for this reason, shipments of products into Russia during the first days of 2017 were stopped. To date, no statistics about the numbers of replacements have been officially published.
The question today is about the regulatory status of medical devices with old forms of “non-replaced” registration certificates which had already been imported into Russia before 2017 – it is unclear if such products can be legally commercialised.
At the same time, it is known that a possible extension of this deadline until 2021 has been suggested, together with other amendments under the current medical device registration rules in Russia. These are now still under the consideration of the Russian government. At the end of the day 30 January, the decision on this consideration has still not been published, so today still such scenario is not excluded.

2.New List of Medical Devices with 0% Value Added Tax
In the first days of January 2017, the Russian government published Resolution #1518 (link in Russian), which amended the list of medical products which were not subject to value added tax (VAT) in Russia. The previous version of the list was published in October 2015.
The new version of the list (link in Russian) contains 45 types of medical products separated into three parts: medical devices, optical lenses and rehabilitation equipment. Medical devices are classified using both “old” all-Russia Product Classification – OKP (for medical devices registered before 2017) and “new” OKPD-2 classification systems.
It should be recalled, that according to articles 149 and 150 of the Russian Tax Code (link in Russian), imports of registered medical devices to Russia should be exempted from VAT in distinction of 10% or 18% for other (medical) products.

3.Request to Report Data for Implantable Medical Devices
At the end of December 2016, the Russian medical device regulator Roszdravnadzor released a letter (link in Russian) aimed at manufacturers of implantable medical devices in Russia and requested them to report data, together with providing customs and finance documentation, for the period from 1 January until 31 December 2016 for the purpose of calculating “weighted-average” prices for each type of implant included in the list of medical devices subject to state healthcare programmes (link in Russian). According to the document, information should be reported using an electronic system, together with hard copies, by 15 March 2017.
The price regulation of medical devices from the list was set in Resolution #1517 at the end of 2015, but the deadline for its implementation has been postponed until the middle of 2017.

Thank you for following this blog! My objective here is to make Russian and Eurasian medical device regulations clearer. You can also follow my news on Twitter @MedDevRus

Three Things You Should Know About Medical Device Regulations in Russia, November 2016.

 

Dear Colleagues and Group Members,

It is the end of November, and welcome to my monthly update on the latest news on medical device regulations in Russia:

 

1.      Will the Deadline for Replacement of Registration Certificates be Extended?

One month is left till the deadline to complete procedure of administrative replacement of medical device registration certificates issued before 2013. According to current medical device registration rules, such registration certificates will not be valid after 1 January 2017. Replacement is free for medical device manufacturers and in practice takes 30-60 days. Based on assessment from different sources, only 20-30% of such registration certificates have so far been replaced. The possibility of extending this deadline till the end of 2021 was discussed with the regulator earlier this year by the Russian trade association IMEDA and it is quite good news that this possibility has emerged in a draft of multiple amendments to current registration rules last month. Will this draft be approved by the Russian Government, and will the deadline be extended? We will discover in December.

 

  1. Russia Harmonised National Standards for In Vitro Products

A number of Russian national (GOST) standards for in vitro diagnostic (IVD) (drafts were introduced last year by Russian Agency of Technical Regulation Rosstandart) came into force on 1 November 2016 and replaced older versions. Now Russian IVD standards are completely identical to relevant international ISO standards:

Russian GOST R ISO 18133-1-2015, identical to ISO 18133-1-2009, establishes general principles and specifies essential requirements for information supplied by the IVD manufacturer.

Russian GOST R ISO 18133-2-2015, identical to ISO 18133-2-2009, specifies requirements for information supplied by the manufacturer of IVD reagent calibrators, control materials and accessories for professional use, and defines the requirements for labels for outer and immediate containers and to the instructions for use.

Russian GOST R ISO 18133-3-2015, identical to ISO 18133-3-2009, specifies requirements for information supplied by the manufacturer of IVD instruments for professional use and also applies to apparatus, equipment and accessories intended to be used with it.

Russian GOST R ISO 18133-4-2015, identical to ISO 18133-4-2009, specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing, calibrators and control materials and accessories intended for use with IVD medical devices for self-testing.
Russian GOST R ISO 18133-5-2015, identical to ISO 18133-5-2009, specifies requirements for information supplied by the manufacturer of IVD instruments and accessories for self-testing.

In Russia, the application of standards is voluntary for medical device manufacturers; nevertheless, following these (and other) standards is the best way to demonstrate compliance during pre-clinical testing and expert evaluation within the Russian medical device registration process.

 

  1. List of Regulations for State Control Activity

The Russian medical device domain is regulated at different levels, which can sometimes seem confusing and contradictory. In November, the Russian healthcare regulator Roszdravnadzor published Order # 12848 with a full list of current regulations and legal acts, containing mandatory requirements, compliance with which is assessed during government control activity by the regulator (link in Russian). Chapters ##12 and 13 are devoted to medical devices and service maintenance of medical equipment in Russia. Although this order does not contain any new legislation, it summarises in a single document an exhaustive list of existing Russian Federal Laws, Government Resolutions and other regulations for this domain. From a practical standpoint, the document can be used as a comprehensive checklist for medical device manufacturers represented in Russia to ensure compliance with local regulations.

 
Thank you for following the blog and newsletter. I am always grateful for your comments, and I encourage you to ask specific questions in the LinkedIn group.

 

 

Three Things you should Know about Medical Device Regulations in Russia, October 2016

 

 

Dear Fellow Colleagues and Group Members,

Let me deliver my selection of highlights on the status of the regulation of medical devices in Russia in October.

  1. Draft of Multiple Amendments to Russian Medical Device Regulations

In October 2016, the Russian Ministry of Health published several draft documents (link in Russian) that are intended to implement significant changes into current key medical device regulations (i.e., Federal Law 323 and Resolution #1416).  In general, the trend of proposed changes is in line with Eurasian medical device harmonization. The key suggested changes are:

  • extended validity of the “old” forms (issued before 2013) of medical device registration certificates until December 31, 2021;
  • allowance of official consultancy from Russian medical device regulator and expert organizations for applications to register medical devices;
  • simplified procedure of registration expertise of in-vitro diagnostic (IVD) products (single stage examination rather than the current two stage process);
  • implementation of mandatory annual reporting to Russian authorities of information regarding efficiency and safety data for class IIb and III medical devices within three years of registration approval;
  • implementation of mandatory regular reporting to Russian authorities of information on lot/batch numbers of class IIB and III sterile single-use medical devices and class IIB and III IVD products;
  • implementation of “180 day rule” after submission or notification of changes in the registration dossier. Medical devices that are manufactured within 180 days of date of approval of changes in the registration by the Russian regulator can be legally imported and circulated in Russia according “old” registration dossier (before changes are approved) .

Published documents are currently undergoing public and expert evaluation and they are expected to come into force by the end of the year.

 

  1. List of Implantable Medical Devices: New Version

On 22 October 2016, the Russian Government extended the list of medical devices that can be implanted into the human body, subject of state healthcare programmes (link in Russian). Compared to the previous version of the list, 160 new medical devices have been added and some old devices have been removed (devices that were not implantable, as classified according to current nomenclature).

Recall that, in accordance with Russian Federal Law №323-FZ, prices for implantable medical devices that are included in state programs and that are included in the list are subject to the state regulation.
The first version of the list, which included 202 medical devices, was published in 2014.
Guidelines (link in Russian) for determining the maximum wholesale mark-up that could be made to the actual selling price of medical devices implanted into the human body were approved and published in 2015.
In August 2016, the deadlines for implementation of price regulation were postponed for one year.

 

  1. New Fees for Amendments to the Registration Dossier

Another draft regulation regarding state fees for amendments to the registration dossier was published (link in Russian) by the Russian Ministry of Health in October 2016. Currently, amendments to the registration dossier (according to Clause 55 of Russian medical device registration rules) are free for applicants and mandatory when technical or quality characteristics of the approved medical device are changed.  The new document implements the following fees:

– amendments to the registration dossier for a medical device – 3,500 rubles (55 USD)

– procedure of expertise of amendments to the registration dossier 30,000 rubles (460 USD) – 55,000 rubles (850 USD), depending on the safety class of the device.

 

The objective of this blog is to make Russian and Eurasian regulations more clear. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group. You can also follow me on Twitter @MedDevRus.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, September 2016

 

Dear colleagues and group members, please find below my selection of highlights in terms of medical device regulations in Russia, for September:

 

  1. State Control over Medical Devices in Russia
    In September, Roszdravnadzor (the Russian medical device approval agency) published a release about the state control over the circulation of medical devices. According to the regulator, 85% of the medical devices [on the Russian market, checked and tested in the context of state control measures] do not meet the required quality and safety requirements. Recall that today’s Russian medical device regulations require a full correspondence of all characteristics (technical specifications, model and size ranges, labelling, software versions), with the data provided in the registration dossier, and in the case of discrepancies with which this data medical product can be considered as unregistered by the regulator.
    State control over the circulation of medical devices has been implemented in Russia since 2013 and includes the possibility of revisions / audits of medical device manufacturers, distributors and clinics by Roszdravnadzor (see full regulation in Russian). Since 2015, Russia has strengthened the responsibility for violations of medical device regulations and today we can see some of the first legal practices on this.

 

  1. Revised Version of Requirements for Technical Files and Instructions of Use for Medical Devices
    The Russian Ministry of Health published a revised version of the draft of requirements for the technical documentation and instruction for the use (IFU) of medical devices. The document clarifies the full list of the information required in the technical file and IFU for medical devices and in-vitro devices. As you probably know by experience and based on the feedback from Roszdravnadzor, discrepancies and lack of consistency or particular information regarding these documents are the most common reasons in registration delays today.
    An interesting innovation for Russia is that the draft regulation allows a shorter version of instructions for the use for medical devices of the I and IIA class (on the condition that such medical devices can be safely used). According to the document, it is also allowed to distribute electronic forms of instructions for use (on the website or on the screen of the medical devices)—in this case, the manufacturer must ensure that the consumer is informed about how to have access to the up to date version and about how to receive their paper version.
    #
  2. Tax Exemption for Foreign Medical Device Components
    A number of amendments to the Russian Tax Code, exempting Russian medical device manufacturers from paying value added tax (VAT) for importing components and raw material for the medical device manufacturer process in Russia, will come into force on the 1st of October 2016. Until that day, Russian medical device manufacturers are required to pay 18% VAT on any imported components for their products, which, in some cases, poses significant restrictions and impacts on the cost of the manufacturing process. New amendments grant VAT exemptions in situations whereas the imported medical device components or the raw materials have no Russian equivalents and in those cases when their intention for manufacturing a medical device is proven. According to experts, the amendments will help to develop the Russian assembly of complex medical equipment, but their implementation in practice may take some time.

Three Things You Should Know about Medical Device Regulation in Russia and Eurasian Union. August 2016

 

Dear Colleagues,

While there was not visible progress in the development of a harmonized Eurasian medical device regulation model in August, there were some quite important regulatory changes in local medical device regulations in Russia and Kazakhstan.
As usual, here are my three highlights for regulatory professionals interested in what is going on in our region:

 

  1. Russia: Price Regulation for Implantable Devices Postponed

On 1 August 2016, the Russian Government amended the following decree adopted at the end of last year: “On state regulation of prices for medical products included in the list of medical devices implanted in the human body…” (Resolution #1517). The corresponding document, Resolution #735, has been published on the Russian legal information portal (link in Russian). According to these amendments, the deadlines for providing documents for medical device manufacturers have been postponed for one year:
-Deadline for registration of maximum sale prices of implantable devices: until 15 July 2017.
-Deadline for the establishment of the regional authorities of maximum wholesale markups to the actual selling prices of the implantable medical devices: until 1 September 2017.
-Deadline for the proposals by Russian Ministry of Health in collaboration with other concerned agencies requiring submissions of the government proposals on the agreed upon procedure of re-registration of maximum sale prices: until 1 October 2017.

 

  1. Russia: Deadlines for the Procedure of Administrative Replacement of Registration Certificates

There are less than five months left until the deadline set by the Russian government in 2012 for the procedure of administrative replacement of “old” registration certificates for medical devices that were issued before 2013. According to Roszdravnadzor (the Russian medical device regulator), less than 9.2 thousand files for replacement have been submitted to authorities by medical device manufacturers since 2013 (out of the 37.5 thousand registration certificates which require replacement). Some experts say that this situation can lead to a problem where a significant number of medical devices may lose their approval in the Russian market from January 2017.
In the same time, the new Eurasian medical device regulation model requires medical device manufacturers to re-register their products by the end of 2021, according to the new Eurasian registration procedure.

Considering this, IMEDA (International Medical Device Manufacturers Association) sent a petition to the Ministry of Health of Russia with the suggestion to extend deadlines for the replacement of “old” registration certificates until the end of 2021.

Later in August, Roszdravnadzor issued a news release pointing out that the procedure for the replacement of registration certificates takes 30 days, and that today “medical device manufacturers have enough time to get new registration certificates.” determining that the statements about potential problems on the medical device market in 2017 stemming from bureaucratic reasons were “baseless.”

 

 

  1. Post-market Surveillance Requirements for Medical Devices in Kazakhstan

Kazak medical device regulator, the National Center of Medicines, Medical Devices and Medical Equipment, clarified in August 2016 that according to the Order MZSR RK #421(link in Russian) regular safety monitoring is mandatory for medical device manufacturers and their authorized representatives (holders of registration certificates with an unlimited validity term in the Republic of Kazakhstan). The regulator recommends submitting periodic safety reports every three months starting from the date of the registration until no later than the tenth day of the month following the report period. The safety report must contain information about product incidences both in Kazakhstan and worldwide and  information about corrective actions. The form for the report is provided in Russian on the website of the regulator.

The objective of my blog is to help regulatory professionals understand the Russian medical device regulatory environment. I would like to remind that you can follow my updates concerning Russian medical device regulations on Twitter @MedDevRus, or receive them directly via email using the “Follow” button on the toolbar of this page.

Three Things You Should Know about Medical Device Regulations in Russia and Eurasian Union, July 2016

Dear Colleagues,

It is the end of July and welcome to my monthly update, in which I share the latest news and updates on medical device regulations in Russia and countries of the Eurasian Economic Union (EEU).

 

  1. Rules of Medical Device Registration in Eurasian Union have been published.

    On 12 July 2016, the Eurasian Economic Commission published the final and approved version of the Eurasian Medical Device Registration Rules (link in Russian) – one of the most long-awaited regulations of the new EEU Medical Device Harmonized model. As was the case previously, the new registration process for medical devices is based on local pre-clinical testing in an accredited laboratory, clinical trials in one of the member states of the Eurasian Union, and a 60-day expertise phase (assessment) by a governmental expert organization (more details).
    In parallel with these new rules, on 5 July 2016, the Russian Ministry of Health published a draft regulation (link in Russian) aimed at amending the Russian tax code and introducing state fees for registration, expert assessment, amendments and renewals of registration certificates under the new Eurasian Harmonized Medical Device registration procedure.
    By the end of July 2016, eleven of the thirteen final editions of second-level regulations will have been published. Experts at the Eurasian Commission expect the new medical device regulation model to be fully operational by the end of the year.

  2. Russia: Medical Device Trade Associations Warn about Potential Collapse of State Procurement of Implantable Devices.

    On 5 July 2016, the Russian Ministry of Health published  guidelines for determining the maximum amount of wholesale mark-up, to the actual selling price, on medical devices implanted in the human body (link in Russian).
    According to the published document, the maximum size of the wholesale mark-up established by Russian regional authorities takes into account the costs associated with the production of these medical devices. Justification for these production costs must be provided by the medical device manufacturer or its authorized representative. As an example, the calculation of the maximum wholesale mark-up, provided in the published guidelines, is from 1 to 7 per cent or 350 – 10,000 Russian rubles, depending on actual selling price.
    At this same time, leading regional and global medical device trade associations together have called on the Russian Government to postpone implementation of price regulation for implantable devices to January 2018, intensify cooperation between the industry and the regulator, and warn about the potential freezing of state procurement of implantable medical devices in Russia.
  3. Federal Law on “Biomedical Cell Products”
    At the end of June 2016, the Russian Federal Law “On Biomedical Cell Products” #180 FZ (Link in Russian) was signed by the Russian President and officially published. This federal law is a basic document which implements the legal terms of biomedical cell products and regulates their research and development with the related donation of biological material, pre-clinical action, clinical studies, registration, circulation, import and export and transportation of such products. The document will come into force on 1 January 2017.

The objective of this blog is to help regulatory professionals better understand the Russian medical device regulatory system. Please post your comments and questions here or in the Russian medical device regulations LinkedIn group.