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

Posted on 28.02.2017 by Alexey Stepanov

Dear Colleagues,

Welcome to my monthly update on medical device regulations in Russia and countries of the Eurasian Economic Union (EAEU). Here are my three highlights for February 2017:

Prolongation of old forms for registration certificates
On 14 February 2017, the Russian government released the Resolution 160 (link in Russian).
The key update on this resolution is prolongation of the deadline for the procedure of administrative replacement of “old” forms of Russian medical device licences issued before 2013.

Recall that, according to the Resolution 1416 of the Russian government issued at the end of 2012, registration certificates for medical products and medical equipment issued before the date of entry into force of the new registration rules (2013) were to be replaced under a special administrative procedure. Initially, entry into force of the measures was planned for 1 January 2014 and then was postponed until 1 January 2017.

The Resolution 160 extends these deadlines again for another four years – until 2021, in line with the end of the transition period for Eurasian medical device regulations.

Russian medical device regulator Roszdravnadzor says more than 10,000 registration certificates were replaced using this procedure from 2013 till 2016. Meanwhile from the other side industry experts assess that up to 10% of licences for medical devices on the Russian market were not updated on time.

The formal timelines for the administrative replacement procedure according to the Russian regulations is 30 business days; the process for application is described here.

Official consulting from Russian medical device regulatory authorities
Another innovation introduced by the Resolution 160 is the possibility for official consultations on the medical device registration process on behalf of Russian regulatory expert centres involved in the registration process. The resolution addresses Russian medical device registration rules with relevant amendments (see clause 58.1), allowing medical device manufacturers to discuss with authorities specific aspects of the regulatory process and requirements.

Recall that previously, Russian law did not allow such forms of consultancy, and direct communication between manufacturers and authorities on any specific question was prohibited.

Considering that lack of transparency still remains one of the key challenges for regulatory professionals in the Russian medical device registration process, such possibility could be especially valuable for medical device manufacturers in the near future.

Fees for Eurasian medical device registration procedure

On 22 February 2017, the Russian Duma released a draft federal law aiming to update the Russian tax code. Among other updates and amendments, the document introduces long-awaited information about amount of fees for a harmonized Eurasian medical device registration procedure.

The total proposed registration fee for a medical device consists of three parts:
a) Constant registration fee: 7,000 roubles (approx. 120 USD)*
b) Fee for the expertise: 45,000–115,000 roubles (750–1,800 USD)* depending on safety class
c) Fee for the “acceptance” procedure: 45,000–115,000 roubles (750–1,800 USD)* depending on safety class for each member state.

Today, lack of established fees for registration is one of the reasons why a harmonized EAEU medical device regulation model is still not working in practice. One can expect that proposed amendments will come into force from the second half of 2017 after approval of both chambers of the Russian parliament.

*RUR/USD rate provided for end February 2017

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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.

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

Posted on 29.12.2016 by Alexey Stepanov

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:

First Year of the Eurasian Union Medical Device Harmonised Regulation Model
On January 1^st 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.
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.
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).
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 29^th December 2016, this suggestion has not been not approved.
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 and Eurasian Union, July 2016

Posted on 29.07.2016 by Alexey Stepanov

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).

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.
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.
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.

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

Posted on 30.06.2016 by Alexey Stepanov

Dear colleagues and group members,

Traditionally, summertime is not a very hot season for regulatory updates, so I am glad to share these three important highlights for medical devices in Russia and the Eurasian Economic Union (EEU):

Update on Eurasian Medical Device Regulatory Model

On 2 June 2016 the Eurasian Commission published final versions of two second-level pieces of legislation for the harmonized Eurasian medical device regulatory system:

Rules for Biocompatibility Testing of Medical Devices (link in Russian)
List of Medical Devices with Measuring Function (link in Russian)

As at the end of June 2016, ten out of thirteen final versions of the Eurasian medical device regulations have been published. The final versions of two of the most crucial documents – “Eurasian Medical Device Registration Rules” and “Guidance for a Quality Management System for Medical Device Manufacturers” are still under discussion between member states and are expected within the near future.

Recall that although the Agreement on Common Principles and Rules of Circulation of Medical Devices formally came into force at the beginning of 2016, the new system is still not working.

Discussions around price registration for medical devices

Some implantable medical devices (i.e. intended for fixation, delivery or extraction of implants or preparation for implantation procedure) may be removed from the “List of Implantable Medical Devices for Medical Aid Provided to Citizens under the Programme of State Guarantees of Free Medical Care” and exempted from the mandatory requirement of price registration. In June the draft law (link in Russian) was prepared and sent to the Russian parliament for discussion and approval.

In this context it should be recalled that 15 July 2016 is the deadline set by the Russian medical device regulator Roszdravnadzor for manufacturers of implantable devices to provide the regulator with information about the prices of their products.

Clear identification of the medical device is critical for proper registration

In June, the Russian press loudly reported a story illustrating an example from current Russian medical device regulatory practice. Because of revealed discrepancies in the Russian registration certificate, Roszdravnadzor deemed the medical devices as non-[properly]-registered, and after that banned products of the UK manufacturer and one of the market leaders in its segment (read more in English).

Over the last few years Roszdravnadzor has increased controls on medical devices and requires notifying about any changes in product name or technical parameters of a registered device to ensure consistency between the registration certificate and the previously submitted registration file. Moreover, in contrast to previous registration rules, which allowed common “family” or “umbrella” registrations, clear identification of the brand name and model of the medical device is mandatory for proper medical device registration.

If you like my updates about Russian medical device regulations you can follow me on twitter @MedDevRus or get them directly via e-mail using the “Follow” button on the toolbar of this page.

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

Posted on 31.05.2016 by Alexey Stepanov

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:

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.

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 1^st March each year.

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 and the Eurasian Union, February 2016

Posted on 29.02.2016 by Alexey Stepanov

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:

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).

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.

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

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

Posted on 20.01.2016 by Alexey Stepanov

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.

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

Posted on 30.11.2015 by Alexey Stepanov

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:

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.

Discussions around the Russian product classification code

FullSizeRender Another 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.

Armenia joins the EEU Agreement for Medical Devices

Armenia Armenia 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

Posted on 02.11.2015 by Alexey Stepanov

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.

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.

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.

Five Questions on Eurasian Medical Device Integration on the Annual National Regulatory Conference

Posted on 02.11.2015 by Alexey Stepanov

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.

Here there are five questions on Eurasian medical device integration answered by Roszdravnadzor.

Question: If a medical device is registered in Russia today, will it be approved for whole Eurasian Economic Union after 1 January 2015?
Answer: No. All medical devices approved in member states according to local procedures remain approved only in the country of registration. For approval in the whole of the Eurasian Economic Union, medical devices must pass through the new EEU registration procedure.

Question: A registration file will be submitted 31 December 2015. Using which procedure will the medical device be registered?
Answer: In this case, the medical device will be registered under the local registration procedure of the member state.

Question: During the transition period, will the applicant have a right to choose which procedure to use (the new EEU procedure or the old local procedure)?
Answer: Yes, during this period it is now expected that the applicant will able to choose between the procedures.

Question: Will a medical device require the new EAC-med symbol for the EEU after 1 January 2016?
Answer: The new EAC-med symbol will be required for medical devices approved under the new EEU registration process. Medical devices approved under local procedures of member states do not need the EAC-med symbol.

Question: As was previously required, all Russian registration certificates must be replaced by 2017. Will enforcement of the new EEU regulations cancel this requirement?
Answer: No, all Russian registrations with unlimited validity issued before 2013 must be replaced by 1 January 2017 under a special administrative procedure. Roszdravnadzor will continue these replacements in 2016.

Этот пост по-русски

Medical Device Regulations in Russia and Eurasian Union

Blog by Alexey Stepanov

Tag Archives: EAC