On 31 December 2019, the Russian healthcare regulator Roszdravnadzor announced first medical device approved under the Eurasian medical device regulations First registration certificate was issued for 2A class neonatal phototherapy lamp manufactured in Russia. The registration record has also appeared in the Eurasian database.
Welcome to my monthly review of medical device regulatory changes in the Eurasian region:
- Eurasian Guidance on the Content and Structure of the Eurasian Medical Device Registration Dossier
On 8 October 2019, the Eurasian Commission published Recommendation #29 ‘On methodical recommendations on the content and structure of documents of the registration dossier for a medical device’(link in Russian). This published document describes the requirements regarding the format, as well as language and legalisation, of documents covering 30 sections of the Eurasian registration dossier of a medical device depending on risk class. Annex II of the document provides guidance on the format of clinical data depending on the safety class of the device and date of clinical trials. Also included is the criteria for acceptance of clinical data from clinical centres outside of the Eurasian Union and requirements for clinical data for an analogue/equivalent device.
It should be noted that requirements for the registration file were previously published and can be found in Annex IV of Regulation #46 (link in Russian), and requirements for the content of technical files is in Annex II and Annex III of Regulation #29 (link in Russian).
- New Devices Added to the List of Regulated Implantable Devices in Russia
On 8 October 2019, the Russian government released Resolution #2333-R (link in Russian), which extended the list of medical devices which can be implanted into the human body for providing medical care under the programme of State Guarantees of Free Provision. According to the published document, there are four new types of devices including polymer ligation clips, ligation end loops, implantable dual chamber MRI compatible pacemakers and associated leads.
The prices for medical devices in the list for these programmes are regulated in the manner prescribed by Resolution #1517 released in 2015.
For today, information about registered prices for these implantables is available on the official website of Russian healthcare regulator Roszdravnadzor
- Kazakhstan Updated Medical Device Classification Guideline.
On 2 October 2019, the Ministry of Health of Kazakhstan released Order #KR-DCM-129 (Link in Russian) and updated the rules for the classification of medical devices and in-vitro diagnostics in Kazakhstan. This document also contains rules for medical software classification. There are still four classes of medical devices categorised by invasiveness, duration of use, contact with patient, implementation with vital organs, and use of energy sources. Compared to previous revision, the structure of this new version of the Kazak classification is closer to the Eurasian medical classification; however, the two are not totally identical and still contain different classification algorithms.
It should also be mentioned that, in October 2019, some minor changes in tax regulations for medical devices have been enforced in Russia and several national GOST standards for plasters, surgical/operating room drapes, dental filling materials and hit implants have been updated and published.
Your feedback, questions and comments regarding my updates are always welcome🙂
This is my monthly selection of updates on medical device regulations in the Eurasian region:
- Changes to the Eurasian Transition Period for Medical Devices
Here is the long-awaited update on the Eurasian transition period for medical devices. On 5 September 2019, the Eurasian Economic Commission published Decision no. 142 (link in Russian) which contained an approved draft of the proposed changes to a transition period for registration for medical devices. According to this document, if a medical device is approved in a Eurasian member state before 31 December 2021, it may be re-registered <only in this member state> using the local re-registration procedure until 31 December 2026. Such a device can be on sale in this member state <but not the whole Eurasian Union> until the expiry of the registration certificate.
Previously, the Eurasian Agreement on medical devices required re-registration of all medical devices using the Eurasian registration procedure before 31 December 2021. In the last two years, several proposals from Eurasian member states to change these transition deadlines have been discussed.
Registrations of new medical devices before 31 December 2021, can be submitted using either the local registration procedure or the Eurasian registration procedure. After 31 December 2021, all new medical devices should be submitted for registration using the harmonised Eurasian procedure only.
The Eurasian member states must first ratify (within 90 days) the draft of Decision no. 142 (link in Russian) before this comes into effect.
While the Ministry of Health of Kazakhstan recently reported the first Eurasian approval of a pharmaceutical product, activity on Eurasian medical device registration is still not too fast: for today there is still minimal information about products submitted for registration. Twenty-five laboratories are accredited to perform registration type testing. However, there is still no clarity as to when the quality management system (QMS) inspection, which is required for registration may begin.
- Draft Guidance to Determine the Costs of QMS Inspection in the Eurasian Union
On 2 September 2019, the Russian Ministry of Health published a draft policy for determining the fees for a QMS inspection before registration of the medical device can take place within the Eurasian Union (link to the document in Russian).
According to Regulation no. 106, which came into force in March 2018, the QMS inspection of manufacturing sites is mandatory for the registration of most IIA-III class medical devices in the Eurasian Union. The scope of the QMS inspection includes the assessment of quality sub-systems, i.e. design and development, document and record management, production and output control, corrective and preventive actions, and consumer-related processes.
The document proposes rules for calculating the cost of an inspection which depends on the number of employees of the enterprise and its location. The document also suggests the duration of the inspection is from four to eleven working days, and that the maximum cost is limited to 2,600,000 RUB (approx. 40,000 USD), excluding the cost of translation services.
- New Rules for Technical Testing of Medical Devices in Kazakhstan
On 6 September 2019, the Ministry of Health of Kazakhstan released Regulation KR DSM-124 (link in Russian) regarding technical trials for medical devices as part of the national registration procedure. According to the document, technical tests of medical devices (not required for in-vitro diagnostics) are carried out as type testing of samples or as data analysis (e.g. for some large-sized medical devices). These tests include assessment of the parameters provided in the technical or operational documentation, evaluation of the ‘design and operability of a medical device in terms of safety, ease of use, operational and ergonomic characteristics’, and an assessment of the labelling and packaging of a medical device. The duration of technical testing, according to the rules, should not exceed 30 calendar days.
I would like to thank LIMI Consulting who helped me prepare the update regarding the Kazakhstan regulation in this post.
In my regular post, let me share information on the main developments and changes of medical device regulations in the Russian and Eurasian regions over the past month:
- Development of Medical Device Registration and Inspection Regulations in Kazakhstan
Last month, several updates regarding registration expertise and inspection requirements in Kazakhstan were enforced:
On 15 May 2019, a new edition of the Order of the Minister of Health of the Republic of Kazakhstan No. 736 ‘on approval of the rules for examination of medicinal products and medical devices’ (Link in Russian) came into effect.
Earlier, on 7 May 2019, the Kazak Ministry of Health enforced another amendment to the Order No. 743 ‘on approval of the rules for assessing production conditions and the quality assurance system for the state registration of medicinal products, medical products and medical equipment’, which came into force (Link in Russian) and updated the criteria for when an inspection is required for the registration of medical devices and pharmaceutical.
Thus, the Kazak regulator clarified that according to amended regulations, the criteria for the inspection of the registration of medical devices in Kazakhstan is required for registering sterile 2A, 2B and 3 class devices in case a manufacturer has never registered or supplied products in Kazakhstan before.
- Update on Eurasian Medical Device Regulations
On 21 May 2019, the Eurasian Economic Commission published Recommendation No. 14 (link in Russian) on ‘the methodological recommendations for the expertise of safety, quality and efficiency of medical products for the purpose of their registration within the Eurasian Economic Union’. This is the third-level document intended to ensure the unification of the requirements for the content of evidence materials submitted for registration expertise across Eurasian member states.
Also, potential prolongation of the transition period until 2026 was announced by the Eurasian commission during the annual regulatory conference FarMedObrashenie in Moscow as one of the possible measures. However, up until today, no official regulations/drafts on this matter have been published (to be recalled that for today, the end of the transition period is set as the end of 2021).
In the same conference, the representative from the Eurasian commission confirmed that four registration files for medical devices are currently under review by the Eurasian competent authorities.
- Voluntary Experiment on the Identification Measures for Wheelchairs in Russia
The initiative for additional marking for identifying medical devices has been discussed since the beginning of 2019 and is one of the priorities for the Russian healthcare regulator as a measure of ensuring traceability and counteract the turnover of counterfeit products on the market.
One of the first steps of this initiative was published by the Russian Ministry of Industry and Trade at the end of April 2019 as the draft resolution of the Government of the Russian Federation “on conducting an experiment on labelling with means of identification and monitoring the circulation of certain types of technical means of rehabilitation (wheelchairs classified as medical devices)” – link to the document in Russian.
According to the published document, an experiment on marking with additional means of the identification of certain types of wheelchairs will be launched in Russia from 1 June 2019 to 1 June 2021.
Participation in the experiment is to be on a voluntary basis, but it is assumed that the pilot project will determine the feasibility of introducing mandatory and additional identification labelling in the future.
Thank you for following my blog, which is a non-commercial project.
My objective is to provide clear and up-to-date information on Russian medical devices.
You can also follow my updates on Twitter @Meddevrus.
This is my usual selection of highlights on the changes made to the medical device regulations and trends across Russia and the Eurasian Union over the last month:
- Some updates on the Eurasian Medical Device Regulations
On 19 April 2019, the Eurasian Commission published Regulation No. 62 ‘On the classification of the areas of intended use for medical devices’ (link in Russian). This third-level regulation document provides a classification system for the intended use of the medical devices that should be used by the applicant in the preparation of documents for the registration dossier.
Earlier, on 3 April 2019, the Eurasian Economic Commission (EEC) published a draft decision ‘On the rules for assessing and authorizing inspecting organizations to conduct QMS inspections.’ (Link in Russian)
According to the official comment in the published document, the EEC does not support the approach proposed earlier, whereby only government bodies can act as inspecting organisations. The proposed draft document contains the requirements and criteria for the QMS inspection organisations, a description of its accreditation procedure (45 days), as well as the subsequent scheduled and unscheduled government audits (at least once over a two-year period).
It should be recalled that on 16 March 2019, it was the end of the transition period which provided manufacturers with a delay in conducting QMS inspections for Eurasian registration.
- The Russian regulator announced a decrease in the number of registration refusals in 2018
On 26 April 2019, the Russian healthcare regulator, Roszdravnadzor, published a video with its annual report for the year 2018. It cites a 38% decrease in the number of registration rejections during last year when compared to the year 2017: 1342 new medical devices were approved and 398 registration applications were rejected in 2018.
In addition, the regulator announced its priorities for regulations concerning medical devices in 2019 as being: an introduction of the unified database of patients with implanted medical devices; the development of labelling approaches for medical devices; and the organisation and carrying out of activities to inspect the manufacturers of medical devices according to the Eurasian regulation model.
- Kazakhstan has amended the requirements for inspections
On 10 April 2019, the government of Kazakhstan published the order No. ДР DSM-26 ‘On Approval of the Rules for Inspection in the Sphere of Circulation of Medicinal Products, and Medical Equipment’ (Link in Russian). The document updates the previously established rules and requirements for conducting inspections of manufacturers of pharmaceutical products and medical devices in accordance with Kazakh legislation.
Thank you for following my blog; it is a non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer. You are able to receive updates directly to your email via the ‘Follow’ button on the toolbar.
This is a selection of the latest updates in medical device regulation across Russia and the Eurasian Union countries for January 2019.
- Eurasian regulations on quality management inspections
The regulation 106 with requirements for the quality management system (QMS) for manufacturers of medical devices for the Eurasian Economic Union (EAEU) registration procedure came into force in March 2018. However, until today the list of organisations conducting these inspections have not been officially published. At the beginning of 2019, we can see the development in the regulations on this subject.
Thus, on 11 January 2019, the Eurasian Economic Commission (EEC) published a draft document ‘on the requirements for inspecting organisations with the authority to inspect manufacturers of medical devices’ (link in Russian).
Later, on 28 January 2018, two potential organisations appeared on this list: the Russian Ministry of Health published a draft document (link in Russian) suggesting that two Russian governmental bodies, Roszdravnadzor and Rosatom, perform QMS inspections of medical device manufacturers according to the EAEU requirements.
It should be also recalled that abovementioned regulation #106 set the end of the transition period and start of QMS inspections for the EAEU medical approval process as of March 2019.
- Some updates in local registration procedures for Russia and Belarus:
There were also some updates for local medical device regulation systems:
On 26 December 2018, the Russian medical device regulator Roszdravnadzor published ‘Methodological recommendations on the procedure for conducting an examination of the quality, efficacy and safety of medical products for state registration’ (link in Russian), approved by both expert organisations involved in the medical registration process. The document may be useful in understanding detailed requirements, national standards and templates of forms used for every step of the medical device examination process during registration in Russia.
Also, on 11 January 2019, the Ministry of Health of Belarus published a letter (link in Russian) clarifying timelines for the different steps of the medical device registration process, inspections and expertise in Belarus.
- Changes in tax regulations for medical devices in Russia and Kazakhstan
On 19 January 2019, according to the law of the Republic of Kazakhstan №211, amendments to the tax code of Kazakhstan came into force, which exempted pharmaceutical products and medical devices from value added tax (VAT). In particular, medical devices, orthopaedic products and hearing equipment, as well as materials and components for their manufacture, are exempt from VAT according to the additionally approved list.
In parallel, on 17 January 2019, the Russian government published the draft regulation (list in Russian) on changes in the list of medical products (Resolution #1042) exempted from VAT. Compared to the current version, the new edition of the list is supplemented with multiple new medical devices classified with Russian OKPD-2 codes.
In my December newsletter I would like to summarise all the major changes in medical device regulations and trends in Russia over the past year. So here are the top stories you should know in 2018 if you deal with medical devices in Russia.
- The development of the Eurasian medical device regulation model has been the most important topic for several years now.
In March 2018, the last «second level» regulation, #106, of the Eurasian Economic Commission (EEC) on the requirements for the quality management system (QMS) for manufacturers of medical devices for the Eurasian Economic Union (EAEU) registration procedure (link in Russian) came into force and was postponed for one year to allow for a transition period. These requirements were developed on the basis of international standard ISO 13485; however, the audits will be based on compliance with the requirements of the EAEU QMS regulation but not with the requirements of the ISO standard itself.
Over the year 2018 the EEC released multiple «third level» medical device regulations:
-Recommendations with criteria for interpreting whether or not a borderline product would be considered a medical device within EAEU regulations (link to the document in Russian).
– Regulation #116 (link in Russian) provides definitions, algorithms, and criteria for the registration of the spare parts, elements, modifications, components, and consumable materials for medical devices in the EAEU.
– Regulation #123 (link in Russian) provides criteria for inclusion (grouping) for registration for several modifications to a medical device in one certificate.
– Methodical guidelines exist for medical device registration expertise for EAEU registration (link in Russian).
– Regulation #25 concerns the criteria for classifying products as medical devices in the EAU (link in Russian).
– Regulation #176 concerns the single register of organisations conducting testing/trials for medical devices for registration in the EAEU (link in Russian).
– Regulation #177 provides a single database on the safety monitoring of medical devices in the EAEU (link in Russian).
English translations of most Eurasian medical device documents are available on the official EEC website.
In November 2018, the EEC announced that the first applications to register medical devices under the EAEU medical device system have been filed for review by the competent authorities in Kazakhstan and Russia.
Over the last year there has been a great deal of discussion on the level of competency of the competent authorities and in the media about potential prolongation of the transition period for the EAEU medical device registration system. There is a draft document available for the end of the year 2018, but no official position has been released on this topic and the end of the transition period remains as 31 December 2021.
- Changes and initiatives in the local regulatory systems in Russia and Kazakstan occurred over the year 2018 in parallel with the development of the EAEU medical device system.
– In June 2018, the Russian government released Resolution # 633 (link in Russian) and simplified the registration process for in-vitro diagnostics in Russia, implementing a one-step assessment process (instead of a two-step process, as previously followed) for all classes of IVDs, which has shortened the overall approval process for IVDs by up to several months.
– Likewise, Resolution # 633 (link in Russian) implements improvements for the registration of medical devices with a pharmaceutical component (which was considered a significant roadblock in the approval of such medical devices in Russia) before.
– Another important initiative for Russia (which has not been approved by the end of 2018) is to suggest an expansion of the list of cases when clinical trials involving human subjects are required for the approval of medical devices. The draft document published in May 2018 introduces a requirement for all medical devices IIB and III classes to undergo mandatory clinical trials involving human subjects, which should be conducted in at least two medical organisations following a single clinical trials protocol.
– In August 2018, the Ministry of Health of Kazakhstan implemented multiple amendments to the rules for examining (expertise) medicines and medical devices.The published order, #347, (link in Russian) provides the updated requirements for the content of the registration dossier, samples for testing, the procedure for conducting the examination for the registration, and harmonising of the major part of the Kazakh and Eurasian algorithms and requirements for assessment.
- Russia chairs the IMDRF in 2019
In conclusion, it should be especially highlighted that in 2019 Russia will be the chairman of the IMDRF and the next two meetings of the IMDRF will be held in Russia: in March 2019 in Moscow and in September 2019 in Yekaterinburg.
The key topics for the meetings for the next year were highlighted as cybersecurity, premarket reviews, and personalised device regulatory pathways.
This was the Russian medical device regulatory landscape in 2018.
I would like to thank everyone for following, supporting, and contributing to this blog, my non-commercial project to make Russian and Eurasian medical device regulations clearer for regulatory professionals worldwide.
I would like to wish you a wonderful holiday season!
See you in 2019; there are many exiting things to come.
Welcome to my monthly review of updates on the medical device regulations landscape in Russia and the Eurasian Union for November 2018:
- First Registration Files for Eurasian Medical Device Registration Procedures and other Eurasian Medical Device Regulations Updates
“The first applications for registration under the Eurasian Economic Union (EAU) medical device system have been filed for review by competent authorities of Kazakhstan and Russia.” It was announced by the Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission (EEC) in Moscow at a conference organized on 15 November 2018 in Moscow by the medical device manufacturers association IMEDA together with the European Association MedTech Europe and EEC. During the same event it was announced that the unified information system for registration of medical devices will be launched “in full mode” by the end of this year. Unreadiness of this system was, until now, considered as one of the main barriers to starting registration procedures for the harmonized market.
In addition, on 16 November 2018, the EEC published approved versions of several third-level documents:
- Regulation # 25 – On criteria for classifying products as medical devices in the EAU (link in Russian);
- Regulation #176 – On the single register of organizations conducting testing/trials of medical devices for registration in the EAU (link in Russian);
- Regulation #177 – On the single database on safety monitoring of medical devices in the EAU ( link in Russian);
Earlier in November, the EEC published English translations of all second-level Eurasian medical device documents. The link is available on the official EEC website.
- Clarification on Valued Added Tax (VAT) for Medical Devices
On 2 November 2018, The Russian Ministry of Finance published a clarification letter (link in Russian) on exemption from VAT for the importation and sale of medical devices in the Russian Federation.
According to the letter, medical devices imported and sold in Russia are exempt from VAT if two conditions are met: the first is the presence of a registration certificate for the medical device, and the second is the inclusion of the product in the list of devices, approved by government resolution No. 1042 of 30 September 2015.
- Update of some Medical Device National Standards in Russia
It is important and often critical to use the most updated version of the national standards for the preparation of the technical documentation, testing, and assessment of medical devices in Russia. Several GOST standards relevant for registration of medical devices in Russia will be updated within the next two months.
Thus, on 1 January 2019 the new versions of the following national standards will come into force:
- Sterilization of health care products. Moist heat (Part 3). Guidance on the designation of a medical device to a product family and processing category for steam sterilization (link in Russian);
- Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 (link in Russian);
- Medical devices utilizing animal tissues and their derivatives (link in Russian);
On 1 February 2019 the following national standards will also come into force:
- Medical electrical equipment. Part 2-49. Particular requirements for the basic safety and essential performance of multi-functional patient monitoring equipment (link in Russian)
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.
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.
- 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.
- 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.
- 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.
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.