About Alexey Stepanov

Medical Device Regulatory and Quality Professional based in Russia.

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, October 2018

Dear Colleagues,

This is my usual monthly review for October with a selection of the latest medical device regulation changes across Russia, the Eurasian Union, and other CIS countries.

 

  1. Updates on Eurasian Medical Device Harmonisation

 

Several interesting small updates happened in the development of Eurasian medical device harmonisation in October 2018:

 

  • At the beginning of October 2018, the competent authorities of Kazakhstan officially suggested to the Eurasian Economic Commission (EEC) to prolong until 2025 the transition deadline from local to the Eurasian medical device registration system (you may recall that current Eurasian regulations set this deadline as 2021). Experts from the EEC announced that the possibility of shifting the transition period is currently being discussed, however, a final decision on the deadline is not yet clear;
  • A very convenient update is the creation of a separate section on Eurasian medical device regulations on the website of the Eurasian Commission (link to the section). The section summarizes a list of Eurasian medical device regulations, a description of approval procedures according to medical device classification, registration documents checklists, a list of competent authorities and accredited laboratories, a database of registered medical devices, and safety monitoring for the Eurasian Union. Materials are currently provided in Russian;
  • Another October update is a draft of the methodical guidelines for medical device registration expertise for Eurasian registration, published (link in Russian) by the EEC. The document is intended to establish uniform approaches to the examination of medical devices and the unification of expert requirements across competent authorities of Eurasian member states for the assessment of the content of the registration dossier.

 

  1. Tightening of Responsibility for Online Medical Product Violations in Russia

In October 2018, the Russian Duma introduced a draft law (link in Russian) that stipulates a tightening of administrative and criminal responsibility for the circulation of counterfeit, poor-quality, and unregistered medicines and medical devices through the internet.

The responsibility for the distribution of falsified, poor-quality, and unregistered medical products was introduced in Russia in 2015, however, the bill emphasised the responsibility for the violations of the distribution of medical products via the internet.

The document meets the requirements of the international MEDICRIME Convention against counterfeit medical products and similar crimes involving threats to public health, which was signed by Russia in 2011 and ratified in 2018.

  1. Possible Regulatory Exclusions for Certain Medical Devices in Ukraine

On 1st October 2018, the Ministry of Health of Ukraine published a draft regulation (link in Ukrainian) that suggested authorising the importation of medical devices and in vitro diagnostics that are necessary in cases of emergency, the implementation of international technical assistance programmes, and some other conditions without the need for established approval/conformity assessment procedures. The document suggests a simplified ten-day application procedure for getting authorisation for the importation of specific batches of medical devices which meet the above-mentioned criteria.

 

 

 

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, September 2018

 

Dear Colleagues,

Here is my usual monthly selection of news about developments in medical device regulations in Russia and countries of the Eurasian Economic Union for September 2018.

  1. Kazakhstan Changes the Rules for Registration Examination of Medical Devices

At the end of August 2018, order #347 of the Ministry of Health of Kazakhstan (link in Russian) came into force and implemented multiple amendments to the rules of examination (expertise) of medicines and medical devices for registration according to the local procedure. 

Order #347 provides updated requirements for the content of the registration dossier, samples for testing, and the procedure for conducting the examination for registration. The expertise process for registration of medical devices consists, as before, of three steps (validation of the registration documents, laboratory testing, and specialised expertise), which take up to 90 working days of real time for I and IIA class devices and up to 160 working days for IIb–III class devices.
In the new edition of the rules, we notice the harmonisation of the major part of the Kazakh and Eurasian algorithms and requirements for assessment.
The new rules also stipulate the possibility of obtaining pre-registration consultancy from the expert organisation.
New requirements have been effective for all medical device submissions for registration and renewals in Kazakhstan since early September 2018.

  1. Russia: Guidelines on Software Registration

On 12 September 2018, Russian medical device regulator Roszdravnadzor published methodological recommendations (guidelines) on the procedure for assessment (expertise) of medical software for its registration as a medical device in Russia (link to the document in Russian).
The published document is intended to establish uniform approaches for the registration assessment of software as a  stand-alone medical device across institutions involved in the medical device registration process in Russia.
The guidelines contain a list of criteria for assigning software to medical devices depending on their intended use, principles for classification and determining the risk category, possible criteria for non-compliance during registration assessment, algorithms for assessment of technical documentation, and a list of national standards used for software evaluation.

  1. Russia to Chair IMDRF in 2019

Russia will replace China as IMDRF (International Medical Device Regulators Forum) chair in 2019; this was announced during the IMDRF meeting in Beijing, China where  the key topics for the next year were highlighted as Cybersecurity, Premarket Reviews, Personalized Device Regulatory Pathways. The upcoming IMDRF meeting in March 2019 was also announced by the Roszdravnadzor management during the industry meeting in September 2018.

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Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, August 2018

Dear Colleagues,

Here is my monthly newsletter with the most important regulatory updates on medical devices in Russia and the Eurasian Union for August 2018.

1. Potential Changes in the Eurasian Medical Device Transition Period for certain group of devices

On 6 August 2018, the Eurasian Commission published a draft regulation (link in Russian) that suggests prolongation of the validity of the medical device registration certificates of Eurasian member states for certain group of devices after the end of the Eurasian transition period.
According to Article 11 of the Agreement on the Uniform Principles and Rules Governing Market Circulation of Medical Devices within the Eurasian Economic Union (signed on 23 December 2014 and enforced on 12 February 2016), registration certificates issued by member states prior to the date of enforcement of the agreement are valid no later than the end of the transition period set as 31 December 2021.
The published draft proposes that medical devices registered by Eurasian member states after the date of the enforcement of the Agreement may be in circulation in that member state until the expiration date of the registration documents.
Thus, in case of approval, this document will allow the Eurasian registration deadline of 31 December 2021 for medical devices registered in Russia and other member states after 12 February 2016 to be disregarded.

2. Memorandum of Understanding on Medical Device Nomenclature

Another interesting update on the development of Eurasian medical device regulations is the draft memorandum (link in Russian) of understanding between the Eurasian Economic Commission (EEC) and the Global Medical Device Nomenclature Agency (GMDN), published by the EEC on 21 August 2018. This document publicises the collaboration and exchange of information between the two agencies with the objective of harmonisation and actualisation of Eurasian and GMDN nomenclature.
You will recall that several regulations on Eurasian medical device nomenclature classification have already been adopted and enforced: Eurasian regulation #177 (link in Russian), adopted in 2015, and Eurasian regulation #46 (link in Russian), adopted in April 2018.

3. Update on the Russian Standard for Medical Device Ethylene Oxide Sterilisation Requirements 

On 1 September 2018, the new version of the Russian national standard GOST ISO 11135-2017 ‘Sterilisation of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilisation process for medical devices’ (Link in Russian) will replace the old version (GOST ISO 11135-2012). The new version of the GOST standard is  identical to the international EN ISO 11135:2014 and sets out how to ensure that medical devices are sterilised effectively, using an ethylene oxide sterilisation process. The new version of the Russian standard should be considered during pre-registration testing, and files submitted for registration after the date of enforcement.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Economic Union, July 2018

 

Dear colleagues,

This is a monthly update with my selection of highlights on medical device regulation changes and trends across Russia and the Eurasian Union.

1. The Eurasian Union: New Third-level Regulations Adopted

On 24 July 2018, the Eurasian Commission adopted and released two new third-level documents entailing Eurasian medical device regulations:

  • Regulation #116 (link in Russian) provides definitions, algorithms, and criteria for the registration of the spare parts, elements, modifications, components, and consumable materials of medical devices in the Eurasian Union;
  • Regulation #123 (link in Russian) provides criteria for inclusion (grouping) for registration for several modifications to a medical device in one certificate. The suggested criteria (e.g. dimension types, group specifications, or same analytes for in-vitro diagnostics) are applicable on the condition that the modifications to the medical device have the same safety/risk and Eurasian nomenclature classifications.

In addition to the documents released in May 2018 and September 2017, so far, six third-level Eurasian medical device regulations have been adopted overall.

2. Russia: Extension of the Restriction List (Draft)

On 24 July 2018, the Russian Ministry of Industry and Trade published a draft regulation (link in Russian) proposing a further expansion of the list that imposes restrictions on state purchases of medical devices from foreign manufacturers in favour of domestic manufacturers, according to Resolution #102. The published document proposed including six new types of medical devices in the restriction list: medical functional beds, concentrates for haemodialysis, tonometers for intraocular pressure, air sterilizers, dry air thermostats, and otorinoscopes.
Resolution #102 was introduced in February 2015 as a measure to support the “import replacement” programme and to promote the development of the domestic manufacturing of medical devices; since this time, the restriction list has been extended several times, in 2016 and 2017.

3. Russia: Updating Medical Device Inspection Checklists (Draft)

On 6 July 2018, the Russian medical device regulator Roszdavnadzor published a draft document (link in Russian) with amendments to the content of the check-lists used for routine inspections of medical devices manufacturers by the regulatory agency. The published draft document proposed removing from the checklist several questions concerning the use of the Russian language on external labelling and instructions for the use of the medical devices. Amendments to this document are due, given that Decree No. 1037 regulating the language requirements for non-food products in Russia was repealed in March 2018.
However, the removal of the questions about the Russian language from the check-list does not mean the repeal of the requirement for the use of Russian on external labelling and instructions for use for medical devices in Russia, which is currently regulated by other Russian and Eurasian documents.

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Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, June 2018

 

Dear fellow colleagues,

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

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

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

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

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

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

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

2.       Eurasian Economic Union: Updated Criteria for Borderline Products

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

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

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

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

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Thank you for following my blog, which is a non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer for regulatory professionals. You can also follow my updates on Twitter @Meddevrus.

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, May 2018

Dear Colleagues, 

Here is my usual monthly selection of highlights about what happened in the Russian medical device regulations landscape in May 2018:

  1. Simplification Requirements for Substance-based Medical Devices (draft)On 30 May 2018, the Russian Ministry of Health published a draft regulation suggesting the simplification of requirements for registration and pre-registration testing of substance-based medical devices in Russia.
    According to regulation #11N, enforced in March 2017, one of the requirements for registration of medical devices with ancillary pharmaceutical substances is mandatory registration of the pharmaceutical component of the product in the Russian register of medicinal products prior to registration of the device. This became one of the most pressing regulatory problems in Russia and increased the number of registration rejections in 2017.
    The amendments proposed in the published draft suggest replacing the requirement above with submitting ‘…documents on quality of pharmaceutical substance <…> taking into account the intended use of a medical device <…> and issued according to the regulation of the country of origin of this pharmaceutical component’. The published draft is now passing through the procedure of public discussions by the end of June 2018.
  1. Mandatory Multi-Central Clinical Trials for IIB and III class devices (draft) 

    Another suggestion of the published draft regulation is the expansion of the list of cases when clinical trials involving human subjects are required for medical device approval in Russia.
    Currently, according to resolution 2N, registration of most medical devices in Russia is mainly based on evaluation of clinical data, and clinical trials involving human subjects must be conducted in accredited clinics after the approval of the ethics council in a limited number of cases: for new types of medical device; for new complex or unique or special methods of prevention, diagnosis or treatment; and in cases where the effectiveness or safety of the medical device are not confirmed in the evaluation of clinical data.
    The published draft document tightens these rules and introduces a requirement for all medical devices of IIB and III classes to undergo mandatory clinical trials involving human subjects, to be conducted in at least two medical organisations under a single clinical trials protocol.
    The same draft document also suggests the innovative new possibility of conducting on-site clinical trials in limited cases.
    It should be also noted that the amendments suggested in the draft document would make Russian and Eurasian clinical trial requirements more similar. Proposed amendments are now passing through the procedure of public discussions by the end of June 2018.

  2. Clarification on application of a reduced tax rate for medical devices in RussiaAt the end of May 2018, the Ministry of Finance of Russia published a letter On the application of the VAT rate of 10 per cent for imported and sold medical products in Russia (link in Russian). In this letter, the regulator clarifies that the list of medical devices taxed at a rate of 10% is approved by Decree of the Government of the Russian Federation N 688 (link in Russian to the latest version, updated on January 23, 2018). This should be guided by the codes of medical products, determined in accordance with the nomenclature of Eurasian customs commodity code EAEU TNVED and Russian product classification code OKPD 2.