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

Dear colleagues and group members,

Welcome to my monthly update on medical device regulations in Russia and countries of the Eurasian Economic Union (EEU). Here are my three highlights for May 2016:

 

  1. Development of the Eurasian Medical Device Regulations

In May 2016, the Eurasian commission published final approved versions of five second-level regulations (which were previously available as drafts) for the Agreement on Common Principles and Rules of Circulation of Medical Devices in the Eurasian Economic Union (EEU):

  • Essential principles and rules on the safety and effectiveness of medical devices (link in Russian) – this document was drawn up on the basis of similar GHTF guidance and provides general and fundamental design and manufacturing requirements on the safety, quality and performance of medical devices (MD) and in-vitro medical devices (IVD). In addition, this document provides common labelling requirements for MD and IVD within the Eurasian Economic Union
  • Rules on conducting technical testing for medical devices (link in Russian) and Rules on conducting clinical trials (link in Russian) provide guidance on conducting pre-submission testing and trials. Good news for IVD manufacturers – in contrast to the current Russian approval process, only clinical trials will be needed in the EEU (skipping the technical tests). Not so good news for implantable devices – full-scale clinical trials with patients’ involvement will be mandatory for their approval
  • Resolution on the EEU medical device mark (link in Russian) – this document provides detailed descriptions of new EAC (EEU) medical device symbols and procedures of EAC-marking for medical devices approved under the new harmonised approval process
  • Resolution on the formation and maintenance of the common medical devices information system (link in Russian), which describes procedures for the common Eurasian database of approved medical devices, clinical centres and laboratories accredited to conduct trials/testing and information on medical devices’ adverse reactions and safety field actions within the EEU.

In these ways, today the full Eurasian medical device regulatory model can be vizualized like this:
EEU 201605

Although currently the new EEU procedures do not work in practice, according to the Eurasian commission, a full-scale launch of the new harmonised system is expected in 2016.

 

  1. The Russian Ministry of Health is considering an extended list of Implantable Medical Devices
    The Russian Ministry of Health is preparing an extension of the “List of Implantable Medical Devices for Medical Aid Provided to Citizens under the Programme of State Guarantees of Free Medical Care“. According to information published in May 2016 (link in Russian), the Russian regulator reviewed 671 applications from medical device manufacturers and medical institutions, with positive decisions made on the majority of them.

    In this context, it should be recalled that the last version of the list (with 207 items) was published in December 2014. According to the Russian Ministry of Health, companies producing Implantable Medical Devices not included in the list will not able to participate in national healthcare programmes from 2017. According to current procedures, applications for inclusion in the list can be submitted to the Ministry of Health by 1st March each year.

 

  1. New Version of Guidelines for Expertise in Medical Devices
    A draft of new guidelines on the expertise in medical devices for procedures of registration was published in May 2016 (link in Russian). This document contains detailed descriptions of the expertise procedure, requirements on documentation format for registration and testing files, and unifies these requirements from two expert organisations. The document will replace the previous version of these guidelines (link in Russian) published in November 2013 and will be expected to come into force formally in the near future.

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

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

Dear colleagues,

Let me share the most important news and updates from the Russian medical device regulatory landscape in March 2016:

  1. Detailed Statistics on Medical Device Registration Processes in Russia in 2015

At the beginning of March 2016, Roszdravnadzor (the Russian medical device regulator) published an annual report with detailed statistics on medical device registration procedures in 2015.

According to this document, over the last year, the regulator received and reviewed 1985 registration submissions, among which 1052 (52%) medical devices were approved (447 for Russian manufacturers and 605 for foreign manufacturers). Another 2705 files were submitted for amendment of existing registration certificates (the so-called ВИРУ procedure), with 1853 (68%) receiving approval. The regulator also reported 1307 authorizations for clinical trials of medical devices, 698 administrative renewals of registration certificates, and 1229 authorizations of samples for pre-submission testing in 2015.

Interesting statistics were also provided on submissions of notifications about changes in technical documentation for approved medical devices (a requirement since 2015), with the regulator making 302 approvals and 312 rejections on these submissions over the last year.
A full version of the report (in Russian) is available on the IMEDA website.

 

  1. Possible Extension of the Transition Period for Medical Device Registrations in Ukraine

From today, there are almost three months left until the end of the transitional period set last year by the Ukrainian Government for medical device manufacturers. Currently, for a significant proportion of medical devices available on the Ukrainian market, approval was received before July 2015 via the old registration procedure; current rules allow such medical products to be imported for sale until 1 July 2016, after which they can be used until the documented product service or shelf life expiration date.

However, the Government of Ukraine is now discussing (link in Ukrainian) extending this transitional period to 1 July 2017. This is happening in parallel with another legal initiative (link in Ukrainian) aimed to ensure the national register retains information about medical devices registered before July 2015, with registration information kept until at least June 2020.

It should be recalled that, since July 2015, medical devices in Ukraine can be approved only through new conformity assessment procedures, as evaluated by the relevant Ukrainian notification body (currently, more than ten conformity assessment centres operate in Ukraine).

 

  1. The Russian Ministry of Health is Updating Requirements for Medical Device Technical Files

In recent years, it has become widely accepted that the failure of regulatory bodies to provide full and clear requirements for assessing the technical files of a medical device poses a major challenge within current registration procedures. According to reports from expert organizations, more than 50% of additional requests during the approval process, as well as registration delays, are related to discrepancies or lack of information in the technical documentation of the registration file. Moreover, in practice, current approaches to reviewing technical documentation may differ depending on the organization reviewing the device.

The Russian Ministry of Health is therefore currently developing new regulations in order to establish transparent criteria for evaluating the technical and operational documentation of medical devices, which will simplify the registration procedure. According to the official website, these new requirements are expected to be finalized by June 2016.

*****

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.

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

 

Dear fellow colleagues,

Let me deliver my selection of highlights on the status of the regulation of medical devices in Russia and the Eurasian Customs Union in February:

 

  1. Price regulation for implantable medical devices in Russia
    One of the most significant topics is the development of price regulations for implantable medical devices for state programmes of guarantees on gratuitous medical care. Following the publication of Government Resolution #1517 in January 2016, on 10 February 2016, Roszdravnadzor (Russian medical device regulator responsible for price regulation and control) published a list of 412 manufacturers, Russian authorised representatives and distributors to whom it will be sending requests to provide information for the calculation of weighted-average prices regarding the medical devices included in this The regulator recommends submitting this information using a newly createdelectronic database no later than 30 days following the day of receiving the inquiry. In parallel, the Russian Ministry of Health has clarified some categories on the list of implantable medical devices subject to price regulations (see the clause below).

 

  1. Amendments to Russian Public Health Protection Federal Law
    At the start of February 2016, The Russian Ministry of Health suggested a number of amendments to the Russian Federal Law 323 on Public Health Protection in the Russian Federation (link in Russian). Though this law is extremely high level and fundamental healthcare act, some of these amendments are relevant to medical devices:
  • Extension of the number of cases when a medical device needs no registration or is allowed to be imported into Russia unregistered; e.g., medical devices imported for research and scientific needs, forensic medicine, trade exhibitions, as well as for vital requirements for a particular patient (using special permissions).
  • The draft introduces the definition of an implantable medical device, which is in line with similar internqtional GHTF definition
  • The draft clarifies categories of implantable medical devices subject to price regulations.

This legal initiative is not yet adopted and is currently in the development phase; the draft can be traced online via the official Russian regulation web portal.

  1. Status of Eurasian Medical Device Integration
    Eurasian integration – how does it work in practice? Though common Eurasian medical device and pharmaceutical regulations formally came into force in January 2016, for the time being, no information is available from member states pointing to the fact that applicants can take advantage of new registration During the Eurasian session of the seminar held by Roszdravnadzor on 4 February 2016, the speaker from the Eurasian Commission reviewed the status of second and third level regulations, and it was announced that these would take effect in March 2016. Also confirmed was the transition period of five years during which a manufacturer will be able to chose either to submit using “old” national or “new” Eurasian processes; previously, the timeline for the transition period had been interpreted ambiguously.

In this blog, I will keep an updated focus on imitative strategic Eurasian medical device updates, as well as on other regulatory updates, which you can follow using WordPress, Twitter or the LinkedIn group.

Alexey Stepanov
Alexey@medicaldevicesinrussia.com

 

 

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

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Economic Union, November 2015

Is it the calm before the storm? In November 2015 we cannot observe major regulatory news and updates for medical devices in Russia and the Eurasian Economic Union countries… In one month’s time the common harmonised market of pharmaceuticals and medical devices will begin functioning (at least formally). Meanwhile, at the current time, there are still a lot of questions to be answered, second-level regulations and guidelines to be published…
Nevertheless, here are some updates which should be useful to know for your Russian regulatory projects:

  1. New version of national standards for labelling requirements for In Vitro devices

In November 2015 the Russian Federal Agency on Technical Regulating and Metrology (Rosstandart) published an updated version of its voluntary national standard GOST R ISO 18133, which is composed of five parts and which contains technical requirements on labelling and accompanying information and documentation for In Vitro Diagnostic (IVD) medical devices (part 1, link in Russian), IVD reagents (part 2, link in Russian), IVD instruments for professional use (part 3, link in Russian), self-testing IVD devices (part 4, link in Russian), and IVD instruments for self-testing (part 5, link in Russian). The new standard will come into force in November 2016 and will replace the version from 2009, which is valid currently. It should be recalled that the use of standards is voluntary, but recommended by Roszdravnadzor as the best way to demonstrate that a medical device meets all labelling requirements during the approval process and into further commercialisation.

  1. Discussions around the Russian product classification code

FullSizeRenderAnother update from the Federal Agency on Technical Regulating and Metrology (Rosstandart) is the extension of validity of the Russian product classification code OKP (ОКП ) until 1 January 2017. The OKP code is a classification code which is present in every registration certificate (in addition to the medical device safety class and nomenclature classification) and is used by customs officials, among others, to define the amount of VAT exemption during medical device import and customs clearance. Previously, the deadline for transition into a new product classification system was set as 1 January 2016, which seemed to threaten a wave of uncertainty in calculation and in applying VAT exemption in practice. It should also be noted that some months ago Roszdravnadzor (the Russian medical device regulator) expressed the opinion that, in future, this code should be removed from the registration certificate.

 

  1. Armenia joins the EEU Agreement for Medical Devices

ArmeniaArmenia ratified the Agreement on common principles and rules of circulations of medical devices signed at the end of last year by EEU countries. In such a way, for November 2015, this agreement is approved by Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia. It should be noted that, at present, unlike in other EEU countries, Armenia regulates the approval process for pharmaceuticals and not medical devices, which suggests quite deep further changes are coming in the medical device sector for the country.

In conclusion, I would like to thank you for the following and remind that you can get regulatory updates about Russian medical device regulations from this blog directly in your e-mail using the ‘Follow’ button in the toolbar in the upper corner of this page.

Three Things You Should Know about Medical Device Regulations in Russia, October 2015

Dear colleagues,

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). Here are my three highlights for October.

 1. The Russian government approved the list of medical products subject to value-added tax exemption.

In the first days of October 2015, the Russian government published resolution #1042 (link in Russian) and approved the list of medical products, which are not subject to value-added tax (VAT). The list consists of three parts: medical devices, optical devices and rehabilitation equipment. Resolution #1042 placed the period in long-lived contradictions between tax and customs legislation for medical devices in Russia. According to article 150 of the Russian Tax Code, imports of medical devices to Russia should be exempted from VAT. However, for several years this rule was a source of controversy for Russian customs, which imposed extra VAT (18% instead of 0%) in some cases due to new terminology for medical devices implemented by the Federal Law #323 in January 2013.

  1. Kazakhstan implemented new fees for the registration of medical devices.

On 22 October 2015, the Ministry of Health of Kazakhstan enforced resolution #771 (link in Russian), implementing new rules for the calculation of fees for the expertise of medical devices for the state registration. New fees are provided for different classes of medical devices and are calculated based on safety class and number of modifications of the device or number of units in the kit in one submission. For example, the minimal fee provided for registration of a simple, low safety class medical device for dentistry is calculated as 48,000 KZT (about 170 USD) per unit; the highest fee of 515,000 KZT (about 2,000 USD) is provided for complex capital equipment.

  1. Eurasian medical device session of the National Annual Regulatory Conference.

Less than two months remain until the enforcement of the Agreement on common principles and rules of the circulation of medical products of the Eurasian Economic Union. A special session of the Annual National Regulatory Conference, FarmMedObrashenie, was devoted to this topic on 19 October 2015, where a representative from the Eurasian Economic Commission made a report on the status of second-level regulations to this agreement. It was reported that no final regulations have yet been published and all documents (thirteen in total) are currently still in ‘a high state of readiness’. All drafts are available online. Possible changes ‘will be of an administrative nature’ only and the final regulations are stated to be enforced ‘in very similar editions’.
Representatives from Roszdravnadzor (Russian medical device regulator) expect that ‘in order to avoid a repetition of the painful Russian experience of 2013’, with high probability during the transitional period imposed in chapter 11 of the Agreement, it will be possible to work on two parallel procedures: the local registration procedure of the country (effective today) and a new procedure of the Eurasian Union. Please see detailed Q&A on this topic in the separate post.

The objective of this blog is to make Russian and Eurasian regulations clearer. 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, August 2015

Dear  colleagues,

I hope you all enjoyed your summer holidays! Allow me to deliver my usual monthly update of the most important regulatory news in the medical device industry for Russia, the Eurasian Economic Union (EEU), and the CIS region:

 

  1. Possible expansion of restrictions on state procurement for foreign manufacturers of medical devices.

In August 2015, the Russian Ministry of Industry and Trade (Minpromtorg) proposed the introduction of a new set of restrictions on the state and municipal procurement of imported medical devices. A new legal initiative proposes to considerably expand the list ‘of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in the Russian Federation’ adopted in February 2015 by way of Decree #102 (link in Russian) which has already imposed a ban on applications to tender for state and municipal procurements for foreign manufacturers of 45 types of medical devices, provided there are two or more entries from manufacturers in Russia, Belarus, Armenia, and Kazakhstan.
The draft of the new initiative, which was published (link in Russian) on the 3rd of August 2015, generated active discussions and an unsought avalanche of attention from the Russian medical device industry as well as non-governmental organisations. “Public discussions” concerning the draft will continue until the 1st of October 2015.
State procurement restrictions may affect antiseptics, disinfectants, medical dressings, some orthopaedic and rehabilitation equipment, condoms, artificial heart valves, defibrillators, dental and endodontic instruments, certain types of ultrasound and X-ray equipment, and some other medical devices. In addition to the 45 medical devices affected in February, there are now more than 90 types of medical devices under discussion.
One should recall that the key strategic objective for Minpromtorg is ‘40% of medical devices for state procurements to be manufactured within Russia till 2020’.

  1. Harmonised Eurasian regulations for medical devices – four months to go.

The Eurasian Commission published a new series of “second level” guidelines concerning anagreement on common principles and rules of circulation of medical devices in the Eurasian Economic Union (EEU).
In August 2015, drafts of the following documents became available:

  • Common Eurasian rules on safety and vigilance monitoring of medical devices (link in Russian).
  • Eurasian rules for medical devices with measuring function (link in Russian).
  • Common Eurasian nomenclature for medical devices (link in Russian).
  • Guidance for conducting clinical trials for medical devices in EEU (link in Russian).
  • Rules for the common Eurasian informational database for medical devices (link in Russian).
  • Common Eurasian requirements on quality management system for medical device manufacturers (link in Russian).

The Eurasian Commission is expected to approve these drafts by the end of September 2015. All approved documents on the Eurasian medical device integration initiative can be found on the official website of the Eurasian Commission.
It is expected that the new medical device regulation system will come into effect in Russia, Kazakhstan, and Belarus on the 1st of January 2016. In these countries, the new system will overhaul regulation approaches for all stages of the medical device lifecycle.
EEU regulations MD

  1. Update on regulations of narcotic substances for medical products

On the 8th of August 2015, the Russian Ministry of Health enforced amendments for the decree #157n (link in Russian) ‘On approval of the maximum allowable amount of narcotic drugs, psychotropic substances and their precursors, contained in medical products’. This decree regulates the maximum amount of such substances permitted per 1 mL of pharmaceutical product or medical device. This may be pertinent to some IVD and dental adhesive materials. The updated and finalised list of substances can be found by following the link in Russian.

*****

The objective of this blog is to clarify Russian and Eurasian medical device regulations. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group  Feel free to follow me on twitter @MedDevRus.