Tag Archives: Russia

Russia is among the Most Difficult Markets to Enter

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Based on the responses of 2,062 industry professionals published in the Global Medical Device IndustryOutlook for 2016 by Emergo Group, Russia and China traditionally was most often cited as more difficult markets to enter.

58 percent of respondents consider that the process of obtaining regulatory approval for a medical device in Russia in 2015 became more difficult than before and only 2 percent of professionals believe that situation became better.

Russia

 

In the same time Roszdravnadzor (Russian medical device regulator) in December 2015 said about “good dynamics” and showed positive trends in medical device approvals.

 

Data published with kind permission of Emergo Group

 

 

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

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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

Russian Duma Ratified the Start of Functionning of Eurasian Medical Device Regulations

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On 20 January 2016, Russian Duma ratified the Agreement on common principles and rules of circulation of medical devices within the Eurasian Economic Union  and the similar agreement for pharmaceuticals. This took another significant step further start of real functioning of common market and regulatory system for medical devices across Russia, Kazakhstan, Belarus, Armenia and Kyrgizstan, which was formally enforced on 1 January 2016.

Related previous posts:

Russia Enforced Price Regulation for Implantable Medical Devices

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On 9 January 2016 the Russian government published it`s Resolution #1517 (link in Russian) “On state regulations of prices of medical devices included on the list of implantable medical devices subject to state reimbursement programses”. The resolution set a deadline as 15 July 2016 for manufacturers or Russian authorized representatives to submit to Roszdravnadzor (Russian medical device regulator) files for registration of the “maximum release prices” of medical devices included in the list.

According to the resolution, the maximum release price proposed by a manufacturer for registration may not exceed the “weighted average price” of the corresponding nomenclature type of medical device defined by Roszdravnadzor according to published method (see clause 3). In the same time, further contract price shall not exceed the registered one.

The timelines for price registration procedure was set as 5 business days.

Related previous posts:

One Year to Replace “Old” Registration Certificates.

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Why?

According to clause #2 of Russian Medical Device Registration Rules (Resolution 1416):

Medical device and medical equipment registration certificates with an unlimited validity period, issued before the effective date of this Resolution, shall be valid until and be replaced on January 1, 2017, with registration certificates in the format approved by the Federal Service for Healthcare Supervision (Roszdravnadzor).

A registration certificate shall be replaced without the repeated state registration of medical devices, on the basis of the application submitted by the applicant to the Federal Service for Healthcare Supervision and containing the information envisaged in the Rules provided for by this Resolution.

Does my certificate need replacement?

How does registration certificate with an unlimited validity period look like (need replacement by 01.01.2017):

old registration1

How does new format registration certificate look like:

new registration1

What is the process?

  1. Sign the Power of Attorney/Autorization letter in the name of Russian Autorized Representative (legalization with apostile is required).
  2. Complete the application form;
  3. Submit the file to Roszdravnadzor (1+2+a scan copy of “old” certificate);
  4. Review time 2-4 weeks (for Q4 2015);
  5. Return paper copy of “old” certificate and get the new one.

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

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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.

Classification of In-Vitro Diagnostic (IVD) products in Russia

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Classification of In-Vitro Diagnostic (IVD) products in Russia is based on similar (but not the same!) principles as described in GHTF/SG1/N045:2008 guidance. Classification rules are described in the Decree of the Ministry of Health #4N (Link in Russian) and more detailed specific national standard GOST R 51088-2013 (link in Russian).  Please note that in addition to classification based on safety class there is nomenclature classifier (link in Russian) which should be considered when IVD is submitted for registration. Please find my summary in the slide below:

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

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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.