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.
Over the last year, in the face of challenges and upheavals affecting global medical device regulations (e.g. the upcoming deadlines for MDR/IVDR and Brexit), the Russian and Eurasian medical device regulatory landscape remained calm and barely raised concerns among the global medical device manufacturers. However, as 2019 comes to a close, allow me to summarise some of the 2019 key regulatory updates of the medical device regulatory sector in this region.
1. Eurasian Medical Device Regulations Recap of 2019
All second-level and most third-level Eurasian medical device regulations have been published and enforced; most local laboratories have obtained Eurasian accreditation and, in some particular cases, they have already started testing. Eurasian regulators are reviewing first registration files; however, as of now, we can hardly announce with confidence that the mechanism of medical device registrations is operating according to the Eurasian rules.
Last year’s crucial update came about when the proposed changes transitioned from the local regulations of the Eurasian member states to the Eurasian medical device regulations system. The initial deadline of 31 December 2021 was changed by Decision #142, published in September 2019. The document proposed by the Eurasian commission postponed the re-registration deadline until 31 December 2026 for all medical devices approved by the Eurasian member states before 31 December 2021. No changes are expected for the registration of new medical devices: local registration of new products will be allowed only until 31 December 2021 after which all new registration submissions must be made using the harmonised Eurasian procedure only. It should be noted that the Eurasian member states must first ratify Decision #142 before it can come into effect; however, no information is available on such ratification for the end of 2019.
Another significant milestone for the Eurasian medical device regulation over the last year was the end of the transition period of QMS inspections, established in Regulation #106 in March 2019. All middle- and high-risk medical devices henceforward may be approved in the Eurasian Union only after the quality control audit of the manufacturing site by Eurasian regulators; as of now, the list of such inspection bodies remains unclear. In September 2019, the Russian Ministry of Health published a draft policy on determining the QMS inspection fees (link to the document in Russian); the policy elaborates on the inspection’s cost and calculation algorithms (as of now, the document continues to have a draft status).
Several other important third-level Eurasian medical device regulations were adopted and implemented in 2019:
- Regulation #62: the classification of the usage areas of medical devices (link in Russian) (published on 16 April 2019);
- Recommendation #14: the examination of the safety, quality and efficacy of medical devices for registration in the Eurasian Economic Union (link in Russian) (published on 21 May 2019);
- Recommendation #29: procedural recommendations on the content and structure of documents of the medical device application dossier (link in Russian) (published on 8 October 2019).
It is also interesting to mention that over the last year, the Russian and Kazak regulators announced the first approved registrations for pharmaceutical products. These registrations comply with the Eurasian pharmaceutical regulations, which were launched simultaneously with the developing medical device regulations.
2. Russian Medical Device Regulations Development in 2019
In parallel with the development of the Eurasian system, several important updates on the local Russian medical device legislation over the last year were announced. Although Russian regulators cite a decrease in the number of registration rejections during the last year compared with the previous one, the registration of medical devices in Russia remains a long and complicated process. Nonetheless, the industry’s experience of dealing with the regulatory requirements have made the process more predictable and understandable.
In August 2019, the Russian regulators solved long-lasting VAT issues of multiple medical devices. The amendments introduced in the rules of medical device assessment clarified the regulatory requirements and approaches for the registration of medical devices containing medicinal products and active pharmaceutical components. In 2019, additional regulations for alcohol-containing medical devices were adopted; these regulations introduced new mandatory application procedures for the special list of such products.
Of all the debated challenges and questions concerning the registration process over the last year, I can mention the unclear requirements for registration trademarks and registration approaches of the Medical Software Regulation.
One of the important initiatives that announced its priorities for Roszdravnadzor over the last year was the development of traceability and identification measures approaches for medical devices. Two initiatives were launched; first, a voluntary trial of rehabilitation equipment and wheelchairs was launched in September 2019. Second, a pilot project was carried out to ensure the traceability of diaper napkins and coronary stents in 2020–2021.
Notably, in March 2019, the Russian Government discussed and approved the concept of ‘Regulatory Guillotine’ as a measure against excessive and ineffective regulations. This initiative allows the overseeing of the existing regulatory frameworks in different areas, such as the regulation of pharmaceuticals and medical devices, and replacing them with new reasonably justified regulatory requirements. This approach will unfold beginning in February 2020. Although very few documents on medical device circulations are currently available, we can expect significant changes related to this initiative in the coming year.
Russia was the chairman of the IMDRF in 2019 and held two meetings in Moscow and Yekaterinburg where it announced the development of Russian medical device regulatory requirements after global harmonisation principles.
3. Updates on Other Countries in the Region
- In July 2019, Ukraine amended the national law of technical regulations and conformity assessment.
- Over the last year, Kazakhstan released multiple updates on the local medical device and pharmaceutical regulations of different levels: new rules for wholesale and retail sales of medical devices (May 2019), new pharmacovigilance and medical device monitoring requirements (May 2019), new requirements for safety and quality examination of medical devices (June 2019), updates on rules for registration and re-registration of medical devices (June 2019), the renew of the classification of medical devices and in-vitro diagnostics (October 2019), and new technical testing rules for medical devices.
- In February 2019, the Government of Kyrgyzstan adopted Decree #311 on certain aspects of registration of medical devices and introduced multiple changes in the medical device regulations in this country.
Thank you, everyone, for following and contributing to this non-commercial blog that tries to clarify Russian and Eurasian medical device regulations for regulatory professionals worldwide.
I would like to wish you a joyful festive season and a very happy 2020.
There have been no major changes in the regulatory landscape of Russian and Eurasian medical devices for the past month, but this is my usual newsletter with several short updates which are good to know if you are interested in medical devices regulation in this region:
1. Updates in Medical Device Control Procedures in Russia
In November several new updates were introduced to strengthen control procedures for medical devices and pharmaceuticals in circulation on the market from Russian healthcare regulators.
On 9 November 2019, the Russian government published Regulation No. 1433 (link in Russian), amending some aspects of the procedure for the inspection of medical devices manufacturers and distributors. According to the published document, within three months, the Ministry of Health is developing a risk indicators i.e. parameters deviations from which might indicate a likelihood of violations of mandatory requirements for the circulation of medical devices, which are intended to be used for unscheduled inspections.
Under Regulation No. 1459 published on 15 November 2019 (link in Russian), Russian healthcare regulator Roszdravnadzor is empowered to conduct test purchases of medical devices and medicines to verify compliance with regulations, i.e. to check on the sale of falsified, poor-quality and non-registered products.
It should be noted that according to the current regulation, inspections of the medical device manufacturers and distributors are carried out in accordance with the annual plan published by Roszdravnadzor. In limited cases, unplanned inspections may be conducted. Strengthening control of the medical devices on the market is a trend that has been evident in Russia over the last several years.
2. Development of Medical Software Regulation in Russia
In November 2019, the Russian Ministry of Health announced the start of work on the implementation of changes to the classification of the software as a medical device. According to the regulator, improvements should be made following the IMDRF guidelines.
As of today, the medical software is within scope of the Russian definition of a medical device, and some years ago Roszdravnadzor clarified the requirement for its mandatory registration, but to date, no specific guidelines are available in the Russian regulations on medical devices.
3. Simplified Approval Path for Refurbished Medical Devices in Belarus
On 16 November the Belarusian Ministry of Health clarified procedures for obtaining import permits for Belarus in the re-used and refurbished medical devices received as foreign donations. The published letter ( link in Russian) sets out a simplified approval process for refurbished medical devices and rehabilitation equipment of I-Class, on the condition that their residual life is not less than one year.
Thank you for following my blog, which is a non-commercial project with the aim of providing timely and clear updates on the development of Russian and Eurasian medical device regulations. Let me remind you that you can receive my regular updates directly from your email via the ‘follow’ button on the toolbar of this blog.
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.
August was rather quiet in Russia and the Eurasian countries in terms of new medical device regulations released. Nevertheless, for those of you interested in the field, here is the usual selection of my monthly highlights:
- Extension of the List of Medical Devices with 0% VAT in Russia
On 19 August 2019 the Russian government published resolution no. 1054 (Link in Russian) and extended the list of medical devices which are not subject to VAT.
It should be recalled that the list was launched in 2015; however, since January 2017, when a new OKPD2 (ОКПД-2) classification came into force in Russia, a significant number of new codes for medical devices, such as certain surgical instruments, computer tomography, certain diagnostic devices, X-ray and ultrasound machines, and electro-diagnostic and scintigraphic devices, were missing from the list. As implemented by Russian tax regulations, the VAT for these products was changed from 0% to 18%. This has led to difficulties with their importation and tax/customs clearance for their distributors and manufacturers.
The updated list uses a new classification system and includes more than 90 new (OKPD-2) codes for medical devices previously missing codes. It also provides VAT preferences for ‘old’ (OKP) codes for medical devices registered before 2017.
- IMDRF Meeting in Yekaterinburg
In 2019 Russia is the official chair of the International Medical Device Regulators Forum (IMDRF). The sixteenth IMDRF meeting and Open Stakeholders Forum will be held from 16-19 September 2019 in Yekaterinburg. The meeting’s key topic has been announced as artificial intelligence in healthcare and the meeting will address regulatory and standardisation activities for medical devices based on artificial intelligence. A detailed agenda is published on the official webpage of the event. Registration is open until 9 September 2019.
It should also be noted that the Russian healthcare regulator Roszdravnadzor announced an internal IVD working group meeting taking place from 20-22 August 2019 within the framework of the IMDRF forum.
The previous IMDRF meeting took place in Moscow in March 2019.
- Update on Notification Requirements on the Start of Activities in the Medical Device Domain
On 9 August 2019 the Russian Ministry of Health enforced Order 3239 (link in Russian) with a new edition of the regulation on notifications on the start of activities in the field of circulation of medical devices. According to the enforced document, any legal entity involved in medical device circulation in Russia must notify healthcare regulators prior to the start of activities. The requirement is not new, but a new edition of the regulations harmonised it with other regulations and allows for the submitting of notifications to any territorial body of Roszdravnadzor in Russia.
Thank you for following my blog, which is a non-commercial project with the aim of making Russian and Eurasian medical device regulations clearer for regulatory professionals. You can also find me and follow my updates on Twitter @MedDevRus
This is my usual selection of highlights and recent changes in medical device regulations in Russia:
- Some Updates in Medical Device Registration and Clinical Trial Requirements in Russia
On 4 July 2019 the Russian Ministry of Health enforced order no. 239N (link in Russian). This updated certain requirements for pre-registration clinical trials (update of order no. 2N), requirements for the content of the technical file and instruction for registration of a medical device (update of order no. 11N). The main updates implemented in the published document are:
- The clarification of and uniform requirements for documents confirming the quality of the pharmaceutical component of drug-containing medical devices.
The first amendments of registration rules (regulation no. 1416) to simplify the registration of drug-containing medical devices in Russia were made in June 2018; later in 2018 Roszdravnadzor clarified requirements for confirming the quality of the pharmaceutical component. However, until July 2019 these registration rules were not harmonised with other Russian medical device regulations (order no. 2N and order no. 11Nr). The order no. 239 seems to finally resolve these discrepancies.
- Henceforth, it is permitted to conduct clinical trials for registration in Russia where a certain type of capital medical equipment is on-site in other countries in ‘organizations where a medical device is located/installed and is approved for use/application’. The possibility of on-site clinical trials is not new, however, previous revisions of order no. 2N permitted clinical trials to be performed ‘during inspection on the place of the manufacturing of a medical device’.
- Russia Launches the List of Medical Devices Containing Ethyl Alcohol
On 2 July 2019 the Russian government enforced resolution no. 774 (link in Russian), which approved the rules for the formation of the list of alcohol-containing medical devices. Medical products included in this list are excluded from general alcohol regulations in Russia i.e the Federal law 171 “On state regulation of the production and circulation of ethyl alcohol, alcoholic and alcohol-containing products and on limiting the consumption (drinking) of alcoholic beverages”. The released resolution provides the criteria for inclusion on the list (based on a product’s intended use, the form of the container or package and the product retail price) along with a list of documents for application for inclusion. Russian healthcare regulator Roszdravnadzor is responsible for the list’s inclusion procedure and has clarified the rules for applications — which should be received <annually> by the regulator between 1 January – 30 June.
- Russia: New Administrative Provision on Medical Device Registration
On 26 July 2019 the Russian Ministry of Health published order no. 3371 (link in Russian) – with a new version of the administrative provision of Russian medical device regulator Roszdravnadzor – on the procedure for the registration of medical devices in Russia. Simultaneously, the previous version of the same document (the Ministry of Health order no. 737) was annulled.
Administrative provision on the procedure for the registration of medical devices is a regulation that establishes the following: the terms and sequence of administrative procedures of the regulator during the approval process, the procedure for interaction between its structural divisions and the interaction between applicants/manufacturers and other government bodies. The new version of administrative provision does not contain critical changes but it is aligned with the last changes of the registration rules and other medical device regulations.
Thank you for following my non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer. You can receive updates directly to your email via the ‘follow’ button on the toolbar of this blog.