Russia Released Multiple Changes in Medical Device and IVD Registration Requirements

It’s a quite a good news for IVD manufacturers… In the first days of June 2018, the Russian Government released the resolution #633 (link in Russian) and approved significant multiple changes in the procedure of registration of medical devices in Russia:

  • Simplification of the registration process of in-vitro diagnostics (IVD) proposing one-step expert assessment (expertise) for registration instead of the current two-step pathway. All classes IVDs pass henceforward through simplified registration process by analogy with class I and non-sterile class IIa medical devices;
  • Significant changes for the list of reasons, requirements and timelines for regulatory renewals (amendments of the registration certificates and amendments of documents of the registration dossier) for already registered devices; the list of cases when expert assessment (expertise) is not required for re-registration was clarified;
  • Update of requirements for documents of registration file for IVDs and medical devices with pharmaceutical component;
  • Extension of the list of reason for registration rejection and cases when registration certificate may be withdrawn/annulled;
  • Other minor amendments on registration procedure e.g. requirement of providing information of trademark, clarification of number of possible additional document requests from the assessment body and clarification of administrative requirements for the applicant…

Overall,  the amendments of the resolution #633 harmonise Russian medical device registration requirements with Eurasian regulations and aimed to simplify IVD and MD approval process.

Three Things You Should Know about Medical Device Regulations in Russia, November 2017

Dear colleagues and group members,

Welcome to my monthly newsletter with the most important regulatory updates on medical devices in Russia for November 2017.

  1. Russian medical device expert organisations are starting pre-submission consultancy
    In November 2017, both Russian expert organisations involved in the registration process announced the start of pre-submission consultations for medical device manufacturers. The expert organisations published information on consultancy procedures, application forms, contracts, information on prices, and required and recommended documents on their websites:
    – Consultations from VNIIMT (ВНИИМТ) expert organization – link in Russian;
    – Consultations from CMIKEE (ЦМИКЭЭ) expert organization – link in Russian;

    According to Roszdravnadzor Regulation 6478 (link in Russian) published in July and enforced in September 2017, the scope of the consultations are: development of a medical device and necessary documentation and testing for registration and re-registration for particular devices, specific aspects of the Russian registration process and requirements, classification of medical devices, and determination if a product meets the definition of a medical device, according to Russian regulations.

  2. Evolution of restrictions on polyvinyl chloride consumables
    On 1 November 2017, the Russian Ministry of Health published a letter (link in Russian) with information on weighted average prices for disposable medical devices from the government list of foreign disposables made from polyvinyl chloride (PVC) plastics, whose admission to public procurement was restricted by Resolution # 968.
    It should be recalled that Resolution No. 967 (link in Russian) and Resolution No. 968 (link in Russian) came into force in August 2017, and extended the list of medical products restricted from participation in state procurements, (link to up-to-date version in Russian) with particular reference to medical devices containing PVC implementing criteria for its manufacturers, and the new scheme of state procurement for such products.
    The national register for manufacturers of PVC consumables that met the criteria is published by the Russian Ministry of Industry and Trade and at the end of November contains one company.

    3. Medical software in telemedicine technologies

    On 3 November 2017, the Russian Ministry of Health published draft regulations on providing medical care using telemedicine technologies (link in Russian). Amongst other matters, the document contains a requirement for mandatory registration of special medical software that is ‘designed for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body and used as a part of information systems’ as a medical device.

    It should be noted that, the Russian medical device regulator Roszdravnadzor has emphasised several times during the past years that medical software should be considered a type of medical device and must therefore pass the mandatory registration process

Three Things You Should Know about Medical Device Regulations in Russia, August 2017

 

Dear Colleagues and Group Members,

Here is my monthly newsletter with the most important regulatory updates on medical devices in Russia for August 2017.

 

  1. Restrictions for Plastic Consumables

In August 2017, the Russian government introduced two important regulations affecting public procurements of a broad range of medical devices made from polyvinyl chloride (PVC) plastics.
According to Resolution # 967 (link in Russian), which came into force on 25 August 2017, suppliers to the Russian market of medical devices manufactured with PVC will from now on be determined from the list of organizations implementing projects to localize the production of medical products in Russia in 2017–2024. The Resolution also sets rules for selecting such suppliers. In particular, organizations must have the right to technical documentation for the respective devices for a period of not less than ten years, and use technologies and raw materials developed within the framework of the Russian “Development of the pharmaceutical and medical industry” programme for 2013–2020.
At the same time, another adopted Resolution # 968 (link in Russian) includes six groups of disposables made of PVC plastics in the list of medical products for which state procurement from foreign manufacturers will be limited  (according to the Resolution #102 dated from February 2015).

 

 

  1. Draft Resolution on Changes to Russian Medical Device Registration Rules

The draft Resolution on Amendments to State Registration of Medical Devices is another important document which was published (link to the draft in Russian) at the beginning of August 2017. The main change proposed in the draft is a simplification of registration of in-vitro diagnostics (IVD): by analogy with the simplification of procedures for I class devices introduced in 2015, the document proposes one-step expert assessment (so called expertise) for registration instead of the current two-step pathway. Another possible innovation proposed in the draft is a significant change of procedure in the amendment of registration certificates and registration dossiers (product re-registration): it proposes a list of changes which do not require expert assessment for re-registration, and establishes a timeline for such re-registration as 15 working days.
As of the end of August 2017, a draft of the document is undergoing regulatory impact assessment by Russian authorities.
 

  1. Adopted Changes in Alcohol Regulations will affect some Medical Devices

On 29 July 2017, Russian authorities adopted Federal Law № 278-FZ (link in Russian), which changes measures to control the turnover/distribution of pharmaceutical substances of ethyl alcohol, including in the production of alcohol-containing medical devices. The regulation defines “alcohol-containing medical device” as a medical device in a liquid form, containing a pharmaceutical substance of ethyl alcohol (ethanol). The published law requires, in particular, additional registration and declaration procedures for legal entities that carry out the manufacturing and turnover/distribution of alcohol-containing medical devices in Russia. According to the regulation, lists of exceptions are established, i.e. “alcohol-containing medical devices” not covered by this regulation. These changes will become operative from 1 January 2018.

 

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

Dear colleagues and group members,

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

  1. Lifting Political Barriers for the Launch of Eurasian Economic Union Medical Device Regulations

    On 5 April 2017, the Kyrgyz Republic endorsed a law “On Ratification of the Protocol on Accession of the Republic of Armenia to the Agreement on Common Principles and Rules for the circulation of medical products within the EAEU”. According to the provisions of the Protocol, Armenia officially joins the above Agreement. Until this date, ratification of this Protocol was one of the main political factors hampering the full launch of the unified medical device market and regulatory model for EAEU countries. The law entered into force ten days after the day of its official publication.

    In this way all the obstacles to beginning the work of a unified pharmaceutical and medical device market have been lifted and all the second-level EAEU medical device regulations (except the quality management system requirements which are not released by the Eurasian Commission yet) are de jure coming into force for all EAEU member states.

    It will be recalled that in recent months official fees for the registration of medical devices according to the new Eurasian procedure were published in Russia, Belarus and Armenia.

 

  1. Statistics on Medical Device Registration in Russia

    At the end of March 2017, Russian medical device regulator Roszdravnadzor published statistics on registration of medical devices for the year 2016. It was reported that 1,465 new medical devices had been approved (which is around 40% higher than the year before) – among them 559 (38%) products manufactured in Russia and 906 (62%) by foreign manufacturers.

    Statistics on MD 2016.jpg
    According to the report, the number of registration refusals decreased by around 9% compared to the year before: the regulator reports 477 refusals with a similar ratio: 163 (34%) for local and 314 (66%) for foreign manufacturers. Roszdravnadzor evaluates the total number of registration refusals for the year as 15.2%.

 

  1. Quality Management System Inspections in Kazakhstan

    On 3 April 2017 the Kazakh medical device regulator (the National Center for Expertise) published a memo (link in Russian) for medical device and pharmaceutical manufacturers clarifying the rules for organising quality management system (QMS) inspection for registration of medical devices and pharmaceutical products. According to the document, for medical device manufacturers QMS inspection is mandatory if a legal manufacturer has never been registered in Kazakhstan before or manufacturing facilities have not been registered in Kazakhstan before, or in cases when conducting an analytical examination is impossible due to the lack or high cost of product samples. The regulator reminds us that the decision about inspection can be taken at any time during the examination. The inspection is carried out within 2-5 working days on one manufacturing site. Valid ISO standard certification of the manufacturer is a necessary condition for the inspection. The Kazak regulator highlights that the manufacturer should: organise the inspection within 30 days after receiving official notification; pay all costs associated with the procedure; and provide translation of necessary information into Russian.

 

Thank you for following this blog! My objective here is to make Russian and Eurasian medical device regulations clearer. You can also follow my updates on Twitter @MedDevRus

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

 

Dear Colleagues and Group Members,

Welcome to my monthly update on the latest news on medical device regulations in Russia and the Eurasian Economic Union. Here are three of the most important updates for March 2017:

 

  1. Russia Released Requirements on Technical Files and Instructions for Use of Medical Devices

 

On 15th March 2017, the Russian Ministry of Health released Order #11N (link in Russian) with a list of requirements for technical files and instructions for use of medical and in-vitro devices (IVD). Undoubtedly, this is one of the most important and long-awaited Orders concerning medical device regulations issued in Russia in the last few years. Since the Russian medical device regulation system changed in 2013, information on the structure of technical documentation was available only as recommendations or voluntary standards, which could be interpreted differently by different institutions. This was one of the most common sources of a lack of understanding of registration requirements and subsequent registration delays.

 

The new requirements became effective from 24th March 2017. Since this date, manufacturers have had to ensure that technical files in registration dossiers for medical devices contain 20 mandatory clauses/chapters (and seven additional clauses for IVD products). Meanwhile the structure of so-called “operational documentation” (i.e. instructions for use (IFU) /product inserts/user manuals) must contain 21 clauses/chapters for all medical devices, with 19 additional clauses for IVD products.

 

As this regulation is relatively recent and no additional guidance has been published, it is difficult to assess the impact at this stage, but it should be noted that some requirements are quite new, for example, one of the requirements for IFU is to provide “the list of data, keys, passwords, and software necessary to mount, set up, operate, and maintain the medical device provided by the manufacturer” (see clause 11g) or to include “the list of national <i.e. Russian?> standards applied by the manufacturer” (see clause 11h).

 

I will closely follow the development of this topic in my blog and publish an analysis of new requirements relating to any additional guidance in future posts of this blog.

 

 

 

  1. Consulting on Russian Medical Device Registration Procedure

 

Following Resolution #160 published last month which (among other initiatives) provided the possibility of official consultations on the medical device registration process on behalf of Russian regulatory expert centres, in March 2017 Roszdravnadzor (the Russian medical device regulator) published the draft regulation with a detailed description of the future consultation procedure. According to the document, consultancy will be performed by two Russian expert organisations involved in the registration process, namely VNIIMT (ВНИИМТ) and CMKEE(ЦМИКЭЭ). Consultations could cover registration and re-registration procedures, question classification of medical devices according to Russian regulations and could be carried out by answering questions posed by applicants, both in oral and written forms.

During consultations, experts cannot perform preliminary assessments of a dossier and cannot cover questions regarding expert evaluation.
A consultancy meeting should be scheduled based on the contract between an applicant and expert centre, and should occur within thirty days of receipt of the applicant`s request for a meeting.

The cost of consulting services and their schedules will be determined by each expert centre.

 

 

 

  1. Reporting Adverse Events in Belarus

 

In March 2017, the Belorussian Ministry of Health clarified its requirements for reporting adverse events for manufacturers of medical devices. According to a letter released on 17th March 2017, the following information must be reported: “serious or unexpected side-effects not mentioned in the instructions for use <of a medical device>, all adverse events during its usage/exploitation, peculiarities of interaction with other medical devices” to include facts of substandard quality and circumstances creating a threat to life and health of patients and medical personnel”. In the same letter, the regulator provided a form for manufacturers or distributors to use for reporting events and warned about responsibility measures in case of potential violations.

 

 

***

My blog is a non-commercial project aimed to make Russian and Eurasian medical device regulations clearer. I would like to remind that you can get my updates directly via e-mail by using the “Follow” button on the toolbar of this page.

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

Three Things You Should Know About Medical Device Regulations in Russia, November 2016.

 

Dear Colleagues and Group Members,

It is the end of November, and welcome to my monthly update on the latest news on medical device regulations in Russia:

 

1.      Will the Deadline for Replacement of Registration Certificates be Extended?

One month is left till the deadline to complete procedure of administrative replacement of medical device registration certificates issued before 2013. According to current medical device registration rules, such registration certificates will not be valid after 1 January 2017. Replacement is free for medical device manufacturers and in practice takes 30-60 days. Based on assessment from different sources, only 20-30% of such registration certificates have so far been replaced. The possibility of extending this deadline till the end of 2021 was discussed with the regulator earlier this year by the Russian trade association IMEDA and it is quite good news that this possibility has emerged in a draft of multiple amendments to current registration rules last month. Will this draft be approved by the Russian Government, and will the deadline be extended? We will discover in December.

 

  1. Russia Harmonised National Standards for In Vitro Products

A number of Russian national (GOST) standards for in vitro diagnostic (IVD) (drafts were introduced last year by Russian Agency of Technical Regulation Rosstandart) came into force on 1 November 2016 and replaced older versions. Now Russian IVD standards are completely identical to relevant international ISO standards:

Russian GOST R ISO 18133-1-2015, identical to ISO 18133-1-2009, establishes general principles and specifies essential requirements for information supplied by the IVD manufacturer.

Russian GOST R ISO 18133-2-2015, identical to ISO 18133-2-2009, specifies requirements for information supplied by the manufacturer of IVD reagent calibrators, control materials and accessories for professional use, and defines the requirements for labels for outer and immediate containers and to the instructions for use.

Russian GOST R ISO 18133-3-2015, identical to ISO 18133-3-2009, specifies requirements for information supplied by the manufacturer of IVD instruments for professional use and also applies to apparatus, equipment and accessories intended to be used with it.

Russian GOST R ISO 18133-4-2015, identical to ISO 18133-4-2009, specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing, calibrators and control materials and accessories intended for use with IVD medical devices for self-testing.
Russian GOST R ISO 18133-5-2015, identical to ISO 18133-5-2009, specifies requirements for information supplied by the manufacturer of IVD instruments and accessories for self-testing.

In Russia, the application of standards is voluntary for medical device manufacturers; nevertheless, following these (and other) standards is the best way to demonstrate compliance during pre-clinical testing and expert evaluation within the Russian medical device registration process.

 

  1. List of Regulations for State Control Activity

The Russian medical device domain is regulated at different levels, which can sometimes seem confusing and contradictory. In November, the Russian healthcare regulator Roszdravnadzor published Order # 12848 with a full list of current regulations and legal acts, containing mandatory requirements, compliance with which is assessed during government control activity by the regulator (link in Russian). Chapters ##12 and 13 are devoted to medical devices and service maintenance of medical equipment in Russia. Although this order does not contain any new legislation, it summarises in a single document an exhaustive list of existing Russian Federal Laws, Government Resolutions and other regulations for this domain. From a practical standpoint, the document can be used as a comprehensive checklist for medical device manufacturers represented in Russia to ensure compliance with local regulations.

 
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