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 and the Eurasian Union, June 2018

 

Dear fellow colleagues,

This is a monthly update with a selection of the latest news on medical device regulation changes across Russia and the Eurasian Union for June 2018.

  1.       Russia: Simplification of the Registration of IVD Products and Other Multiple Changes in Medical Device Registration Rules

During the first few days of June 2018, the Russian government released resolution # 633 (link in Russian) and enforced the long-awaited multiple changes in the Russian medical device registration rules.

The enforced changes have a most significant impact on the procedure for the registration of IVD products. Henceforward, all classes of IVDs pass through a one-step assessment process (instead of a two-step assessment process, as previously followed), eliminating several months of the assessment phase in obtaining authorisation for clinical trials. From now on, mandatory local clinical trials for diagnostics may be conducted in parallel with technical assessment before submission to the Russian competent authority, Roszdravnadzor. This may, hopefully, shorten the overall challenging approval process for IVDs in Russia by up to several months.

Another significant change affects the registration of medical devices with a pharmaceutical component. The resolution released replaced the requirement for the mandatory registration of the drug component as a pharmaceutical substance in Russia (which was considered a significant roadblock in the approval of such medical devices in Russia) by a new requirement to provide confirmation of the quality of the drug component according to the regulations in the country of its origin.

The enforced changes will also affect the procedure for registration renewals (amendments of the registration certificates and amendments of documents of the registration dossier), introducing classification of the registration renewals depending on the product/design changes.

Some other minor changes in the registration procedure and timelines overall were aimed at simplifying the IVD and medical device  approval process and making registration requirements similar to upcoming Eurasian medical device registration rules.

2.       Eurasian Economic Union: Updated Criteria for Borderline Products

On 22 June 2018, the Eurasian commission published an updated version of the draft of recommendations with criteria for interpreting whether or not a borderline product would be considered a medical device within the terms of Eurasian medical device regulations (link to the document in Russian).

The document provides guidance for how to classify products as medical devices, in-vitro devices, cosmetic/toiletry products, disinfectants, general purpose products, assistive/rehabilitation products, products for sports or leisure, personal protective equipment, medical software, medical packaging, physiotherapy devices, medical furniture, medicinal products and medical devices with a drug component and some other products depending on their intended use.
These criteria can be used in the preparation of documents for the registration of medical devices and also in the examination of the effectiveness of medical devices in accordance with these rules.

3. Kazakhstan: New List of Medical Products Exempt from VAT

On 15 June 2018, the Ministry of Health of Kazakhstan, according to its resolution #124, enforced the new list of medical products (pharmaceutical products and medical devices) for which the selling and importing are exempt from value added tax (VAT).
The new list is available online (link in Russian).

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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 for regulatory professionals. You can also follow my updates on Twitter @Meddevrus.

Three Things You Should Know about Medical Device Regulations, April 2018

Dear Colleagues,

This is an update for April with a selection of the latest news on medical device regulation changes across Russia and the Eurasian Union countries.

  1. Statistics on Medical Devices in Russia in 2017

At the beginning of April 2018, Russian medical device regulator Roszdravnadzor announced statistics and published a detailed report on approvals of medical devices and post-market control for 2017. It detailed about 1403 new medical devices approved in the last year. It should be noted that, compared to previous years, this amount showed a decrease for the first time since 2014.
The published report (link in Russian) also mentions a significant increase of registration rejections in the last year (647 rejections in 2017 against 477 in 2016), caused, according to the regula

tor, by “among other factors, enforcement of Order 11N on requirements on technical file and instruction for use for registration” in March 2017.

Roszdravnadzor also reports positive decisions to amend 3548 registration certificates and 570 registration dossiers in 2017. The total number of files submitted to the agency by medical

device companies was reported as 5262.
Regarding post-market control, the regulator reports about 5124 inspections and 827 examinations (expertises) of medical devices approved on the market which in 89.5 % cases revealed non-conformities of the examined medical devices with current Russian regulations.89,5.png

  1. Price Regulations for State Procurements of Medical Devices in Kazakhstan

At the end of March 2018, the Ministry of Health of Kazakhstan enforced Order #112 (link in Russian) and updated requirements on the registration of prices for medicines and medical devices for state procurements within the guaranteed free medical care. According to the document, medicines and medical devices may be purchased at prices not exceeding those established by the competent authority. The requirement is applicable for purchases by government institutions within the guaranteed free medical care or using health insurance funds.
Updated rules and guidelines for price and mark-up registrations have been published previously (link in Russian). Prices may be submitted online and should be registered by the competent authority within ten working days. The deadline for submission of information on prices was set as 27 April 2018 by the competent Kazakhstan authority (National Centre of Expertise).

  1. Several Eurasian Medical Device Regulations Approved

There was no breakthrough in start of functioning of Eurasian medical device regulations model in April 2018 compared to previous month; however, the Eurasian Commission approved several “third-level” regulations which come into force in May 2018:

-Regulation #46 on nomenclature of medical devices in EAEU (link in Russian);
-Regulation #47 on classification on adverse events for medical devices (link in Russian);
-Regulation #48 on classification of documents of the registration dossier (link in Russian).

In addition, one other interesting and detailed document published in April 2018 is the draft of the updated guidelines/recommendations for the expertise of medical devices for registration according to Eurasian requirements (link in Russian); however, as of the end of April 2018 the final approved version of the document is not available.

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

 

 

Dear colleagues and group members,

 

Here is May’s monthly newsletter, showing a selection of medical devices and regulatory highlights for Russia and the Eurasian Union.

 

  1. Developments in Eurasian Economic Union (EAEU) Medical Device Regulation

“On May 6, 2017, the main regulation acts of the EAEU, ensuring the functioning of the common markets for medicines and medicines, are coming into force” –this statement was made  by the Minister of the Eurasian Economic Commission, Valery Koreshkov, at the very beginning of May. Thus, ten days after the ratification of the protocol on Armenia’s accession by the Kyrgyz Republic, most of the ‘‘second level’’ documents regulating the circulation of medical devices in the single market of the Eurasian Economic Union came into operation. The thirteenth and last ‘‘second level’’ document on the requirements for the quality management system (QMS) has not yet been adopted or entered into force. However, this is not likely to be an obstacle to the launch of a single medical device market.

Later, on 24 May 2017, the Eurasian Commission published the first draft of “third-level” regulations – recommendations on a list of applicable standards to ensure compliance with essential principles of safety and efficacy of medical devices in the EAEU (link in Russian). The document contains a list of 43 standards (mostly Russian GOSTs and Belorussian STBs) which may be voluntarily used by manufacturers and testing laboratories of member states to demonstrate conformity with new Eurasian medical device regulations. The Eurasian Commission recommends that member states implement the list gradually, within six months from the day of its official publication.

In addition to this, Russian healthcare regulator Roszdravnadzor announced an upcoming one day seminar and webcast on the registration of medical devices in accordance with the changes in the legislation of the EAEC. This will take place in Moscow on 8 June 2017. The agenda of the seminar also covers topics relating to clinical trials, vigilance requirements and implementation quality management systems according to EAEU requirements.

  1. Medical Device Nomenclature in Kazakhstan

On 22 May 2017, the Ministry of Health of Kazakhstan approved new nomenclature of medical devices harmonised with the Global Medical Device Nomenclature (GMDN) together with the Methodological Guidelines for the Formation and Maintenance of the Nomenclature of Medical Devices of the Republic of Kazakhstan. Nomenclature of medical devices may be used for registration, traceability, public procurement and post-registration control for medical devices. New medical device nomenclature is available online (link in Russian) and contains a list of medical devices, including their names, relevant codes and descriptions of their types, as well as classification characteristics used for search and classification.

  1. Russian Regulator Updates Checklist for Control Inspections

At the end of April 2017, Russian healthcare regulator Roszdravnadzor published its order #4043 (link in Russian) and updated the “list of regulations containing mandatory requirements, the observance of which is assessed in the course of state control”. The abovementioned list replaced the previous version published by the regulator in November 2016 (Order #12848). Section three of the published list is devoted to state control of medical devices and summarises the full list of applicable regulations which is assessed by Roszdravnadzor during audits and inspections of manufacturers of medical devices and medical facilities in Russia.

 

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

Five Things to Know about Medical Device Regulations in Russia in 2016

Dear fellow colleagues and group members,

 

As the year is coming to a close, in my final post of 2016 I would like to summarise the most remarkable and important updates that have taken place in medical device regulations in Russia and the Eurasian Union this year. Thus, here is the 2016 Russian regulatory environment at a glance:

  1. First Year of the Eurasian Union Medical Device Harmonised Regulation Model

    On January 1st 2016 the Agreement On the Common Principles and Rules of Circulation of Medical Devices in Eurasian Economic Union (EEU) officially came into force. Nevertheless, in practice, the common harmonised Eurasian system is still not working.

    During the year, the Eurasian Economic Commission (EEC) developed second-level regulations. At the end of the year, twelve out of thirteen legal documents were approved, including new approval (registration) rules for medical devices in the Eurasian Union. One of the most discussed of these second-level guidelines are the requirements for a quality management system for medical devices. Manufacturers are expected to implement mandatory quality audits for most medical device manufacturers for registration within the EEU in 2018.

    In addition to the second-level regulations in 2016, the EEC published twelve drafts of third level documents for the above mentioned agreement (e.g. list of voluntary standards, requirements for technical maintenance, recommendations for categorising borderline medical products, recommendations on the content and structure of the registration file). These have currently not been discussed.

    In November 2016, the Russian medical device trade association ― IMEDA ― together with the MedTech Europe Associations, held the Round Table “Common Market of Medical Devices: Supranational Regulation Model” in Moscow. Representatives of the EEC, together with European regulators, shared practices and discussed fundamental approaches to forming the common market of the MDs.

    According to the Agreement, today all member states of the Eurasian Union (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan) are in a transitional period. This Agreement allows  developing a Eurasian medical device regulation model, in parallel with local medical device regulations of the member states. This transition period is set to end in 2021.

  2. Russia Continues Clear Trend of Supporting Local Medical Device Manufacturers

    In 2016, the Russian government has continued its course on import substitution, which started as a “crisis management plan” in 2014.

    In December 2016, the Russian government published Resolution #1268 (link in Russian) and significantly extended the list of certain medical devices that originate from foreign manufacturers. This was initially implemented in February 2015 in the famous Resolution #102, which allowed the rejection of applications for tenders of foreign manufacturers of medical devices on the list in case if two (or more) similar products manufactured in Russia, Belarus or Kazakhstan were proposed. However, in practice, Russian device manufacturers included in the list had to obtain a special ST-1 certificate (not a simple process), in order to prove their products belonged in a “local” category.

    Another measure intended to help develop the Russian assembly of complex medical equipment is the amendment of the Russian Tax code. This was implemented in October 2016. It provided support to Russian medical device manufacturers, exempting them from paying value added tax (VAT) for the importation of components and raw material for the manufacturing process in Russia.

    Another example is a message from the Russian Federal Antimonopoly Service published in September 2016. They raised a sensible topic for foreign manufacturers of in-vitro diagnostics (IVD) systems and started the discussion to replace “closed” IVD systems with open ones.

  3. Regulation of Implantable Medical Devices is Continuing to Develop

    Price regulations of implantable medical devices ― an initiative that started in 2015 ― had a number of updates in 2016:

    In January 2016, the Russian government published Resolution #1517 (link in Russian) titled “On state regulations of prices of medical devices included in the list”, which set the methodology for how mark-ups on such devices should be calculated.

    Since February 2016, the Russian medical device regulator Roszdravnadzor has started requesting from manufacturers of implantable medical devices and Russian authorised representatives information about weighted average prices for their products. This uses a newly created electronic database.

    In July 2016, the Russian Ministry of Health published guidelines for determining the maximum amount of wholesale mark-up on medical devices implanted in the human body.

    In August 2016, the Russian government postponed all deadlines stipulated by the Resolution No. 1517 for one year:

    -Deadline for registration of maximum sale prices of implantable devices: delayed until 15 July 2017.
    -Deadline for the establishment of the regional authorities of maximum wholesale mark-ups to the actual selling prices of the implantable medical devices: delayed until 1 September 2017.
    -Deadline for the proposals by the 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: delayed until 1 October 2017.

    In 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 (more than 360 in summary) and some old devices have been removed (devices that were not implantable, as classified according to current nomenclature).

  4. Development of Local Medical Device Regulations in Russia

    The Russian medical device registration process continues to perplex regulatory professionals due to lengthy review times and a high number of rejections. Here are some developments that took place in 2016:

    In July 2016 the Russian Ministry of Health published requirements for the technical documentation and instruction for the use (IFU) of medical devices. This clarifies the full list of the information required in the technical file and IFU for medical devices and in-vitro devices.

    In August 2016 the Russian Ministry of Health implemented a mandatory procedure for medical device manufacturers to submit amendments in the registration dossier for approved medical devices. This is in cases where technical documentation has been changed.

    In October 2016, the Russian Ministry of Health published several draft documents (link in Russian) that are intended to implement significant changes in key medical device regulations. These include simplification of the registration process for IVD products, mandatory safety reporting for high class risk medical devices, and the allowance of official consultancy from Russian medical device regulators. Currently amendments have not been approved; discussions are due to start at the beginning of 2017.

    Since August 2016 there has been vivid discussion about a possible extension of the deadline for the procedure of administrative replacements of “old” forms of the registration certificates; nevertheless as of end of the day the 29th December 2016, this suggestion has not been not approved.

  5. Development of Local Medical Device Regulations in Kazakhstan

    Compared to Russia, the medical device approval process in Kazakhstan remains quite predictable. However, several significant changes in the regulations in 2016 should be highlighted:

    Since mid-2016 the Order of Kazak Ministry of Health #421(link in Russian) came into force and introduced mandatory regular safety monitoring of medical device manufacturers and their authorised representatives in Kazakhstan. The regulator recommends submitting periodic safety reports that contain information about product incidences and corrective actions both in Kazakhstan and worldwide every three months. This should start from the date of the registration until no later than the tenth day of the month following the report period.

    Moreover, in November 2016, the Kazak government published Resolution # 634 (link in Russian) and among others changed the requirements and implemented restrictions for visual advertising of medical devices.

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That is it for 2016; I would like to thank everyone for following, supporting and contributing to this blog and professional group. I would like to wish you a very happy holiday season and New Year filled with peace, prosperity and great achievements!

Alexey Stepanov
Alexey@medicaldevicesinrussia.com

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, 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.