Extension of the List of Implants for National Healthcare Programs

On 31 July 2017 the Russian government published the Resolution #1587-r (link in Russian) and extended the list of implantable medical devices for national free healthcare aid programs. The existing version of the list with 359 types of implantable medical devices (link in Russian) have been completed by new 23 types of devices  most of which are intended for preparation for surgical interventions as well as delivery, fixation and extraction of implants.

Initially, the list was implemented in the end of 2014, and for today, according to Russian Federal Law 323-FZ, presence of a product in the list is a mandatory requirement for  its participation in national healthcare programs. Products in the list are subject of maximum sales prices and maximum mark-ups regulation in Russia.

Three Things You Should Know About Medical Device Regulation in Russia and CIS, June 2017

 

Dear Colleagues and Group Members,

This is a monthly update with my selection of highlights for June 2017 on medical device regulation changes across Russia and CIS:

 1. Ukraine Completely Switched to New Medical Device Approval System

1 July 2017 is the end of the transition period from the system of state registration of medical devices to the assessment of conformity with Ukrainian Technical Regulations No.753, No. 754 and No.755.
After this date, medical devices approved under the “old” procedure that were put onto the Ukrainian market before this date will be allowed for distribution without passing the conformity assessment procedure and without a conformity mark. According to new regulations, these products will be allowed to be on the market before the end of their shelf lives, but not for more than five years from the date of their introduction into circulation.

The new Ukrainian medical device approval system is currently very similar to the European medical device and In-Vitro Diagnostics (IVDs) approval process, however the CE mark itself does not entitle a product to be placed on the Ukrainian market without meeting the requirements of local technical regulations.

The new Ukrainian medical device conformity assessment procedure is defined depending on safety class. The most common ways of assessment today include audits of manufacturing sites or batch conformity assessments. Low-class medical devices are mostly self-declared.

Other important requirements of the new approval system include the mandatory appointment of authorised representatives of manufacturers in Ukraine and mandatory use of  Ukrainian language on the product labelling.

At the end of June 2017, the Ukrainian state register of medical devices contained 3764 approved devices, while the website of the Ukrainian Ministry of Health listed 13 accredited notification bodies for medical devices and eight notification bodies for IVDs.

 

2. Deadline for Price Registration for Implantable Devices in Russia
Another important date on the Russian regulatory landscape is 15 July 2017 – this deadline was set by Resolution 1517 (link in Russian) for manufacturers of implantable medical devices and their authorised representatives to submit documents to Roszdravnadzor, the Russian healthcare regulator, for the registration of maximum sale prices for implantable medical devices included in the list for the programme of state guarantees for free provision of medical care (link to the last version of the list in Russian). A list of documents for price registration is defined in Clause 4 of the price registration rules (link in Russian). According to these rules, with proper preparation of the documents, a decision on the price registration should be taken by the regulator within five business days. Meanwhile, in June 2017 the Russian regulator started publishing information about “average-weighted” prices agreed with the Russian Federal Anti-Monopoly Service (FAS). Published prices were provided using a Russian nomenclature classification system.

3. Further Development of the Eurasian Medical Device Regulation Model

After the formal entry of documents at the second level of the Eurasian harmonised system for regulating the circulation of medical devices came into force in May 2017, this system continues to develop. Thus, in June 2017, the Eurasian Commission published drafts of a number of new third-level documents:

  • On the classifier of the types of adverse events associated with the use of medical devices (link in Russian)
  • On the classifier of kinds of documents of the registration dossier on a medical device (link in Russian)
  • On the nomenclature of medical devices (link in Russian)
  • On the Consultancy Committee on Medical Devices (link in Russian).

From today, documents are available as drafts, which remain under public discussion status until the end of July.

 

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I would like to thank IMPROVE MEDICAL for providing updates on the development of Ukrainian medical device regulations. The IMPROVE MEDICAL conformity assessment body is based in Kyiv and performs conformity assessment with Ukrainian technical regulations for medical products.

You can also follow my news subscription on this page or on Twitter @MedDevRus

 

 

 

 

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

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 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 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.