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.
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.
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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.
Welcome to my usual monthly review containing the most important medical device regulation changes across Russia and the Eurasian Union over the past month:
- New Restrictions on State Procurements for Certain Medical Devices in Russia
On 26 June 2019, the Russian government published Resolution # №813 (link in Russian) and extended the list “of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in Russian Federation”.
The state procurement of medical devices included in the list, according to the Resolution #102 introduced in 2015, will be closed to foreign manufacturers if at least two bids on medical devices from local manufacturers (Russia, Kazakhstan or Belarus) were submitted for tender.
Above-mentioned Resolution # №813 has added 14 new types of device to the restriction list including ventilation devices, gamma-therapeutic radiation complex, ultrasound devices, certain types of endoprosthesis, external fixation devices, medical beds, intraocular lenses, intraocular tonometry, micro sources with iodine-125, certain adhesive dressings and surgical materials, medical devices for storage and transporting biological samples, air sterilisers and dry air thermostats.
According to the published document, analogs of each of these products are currently produced in Russia in sufficient volume by at least two local companies. The decision was taken with the aim of supporting the development and production of these products in Russia.
The new revision of the list is available in Russian.
- Russian Ministry of Health Clarified Trademark Requirements for Medical Device Registration
The requirement to provide confirmation of the legitimate use of the Russian trademark for registration of a a medical device is a relatively new requirement, which was introduced by the Resolution 633 in June 2018 and raised a lot of questions and confusion across registration applicants over the last year.
Thus, according to the petition initiated by Russian medical device registration consulting company Medrelis and 28 medical device companies submitted to the Russian Ministry of Health in May 2019, over the past year the interpretation of trademark legitimacy by Russian health care regulator Roszdravnadzor was often controversial and led to additional difficulties in the registration procedure and an increased amount of registration rejections.
On June 2019, the Russian ministry of health, for the first time since the enforcement of the new trademark requirements, clarified (the letter kindly provided by Medrelis) that Roszdravnadzor, to prevent the circulation of counterfeit medical devices, may compare (verify) information provided <for registration of a medical device> by the manufacturer or the authorised representative of the manufacturer (s) with information received, inter alia, as “interdepartmental information interaction” (which means that missing documents confirming trademark legitimacy in the registration file may not be a reason for the registration rejection or additional requests to the applicant from the regulator).
- Multiple Updates of Regulations for Medical Devices and Pharmaceuticals in Kazakhstan
Kazakhstan continues to release multiple updates to local medical device and pharmaceutical regulations started earlier this year. Thus, for the past months the following regulations have been released in new revisions:
- On 02 May 2019 – the order KR-DCM 53 (Link In Russian) updating the rules of wholesale and retail sales of medicines and medical devices.
- On 27 May 2019 – Order KR-DCM-88 (Link in Russian) updating pharmacovigilance requirements for pharmaceuticals and rules for safety monitoring of medical devices;
- On 7 June 2019 –the Order KR – DCM 82 (Link in Russian) updating requirement rules for assessing the safety and quality of medicines and medical devices registered in Kazakhstan;
- On 9 June 2019 – the Order KR – DCM 87 (Link in Russian) updating rules of state registration, re-registration and amendments of the registration dossier for pharmaceutical products and medical devices.
Dear fellow colleagues,
This is my usual newsletter with a selection of updates regarding the medical device regulation landscape in Russia and the Eurasian Union for the last month.
- International Medical Device Regulators Forum in Moscow
The 15th International Medical Device Regulators Forum (IMDRF) and Open Stakeholders Forum were held from 19–21 March 2019 in Moscow. Here are some of the most important outcomes from the event:
The Russian healthcare regulator Roszdravnadzor reported about preparation at the conclusion of the Forum with regard to final versions of the following documents, which are “in process of implementation as part of the Russian regulation system”:
- ‘Principles of labelling of medical devices, including medical devices for in vitro diagnostics’;
- ‘Guidelines for the application of the system of unique identification of medical devices UDI’;
- ‘Terminology of adverse events: terms, structure, codes; Appendix E, F’;
- ‘Electronic registration for medical devices (IVD & non IVD)’;
On 20 March 2019 the IMDRF issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents explaining how to build submissions using its table of contents structure.
Moreover, ahead of the Forum on 18th March 2019 the Global Medical Device Nomenclature (GMDN) Agency signed a Memorandum of Cooperation with the Eurasian Economic Commission to enable it to use the GMDN to support the improved identification and regulation within the Eurasian medical device regulatory system.
The next meeting of the IMDRF Leadership Committee is planned for 16–19 September 2019 in Yekaterinburg.
- Russia is Discussing a Potential New Regulatory Path for the Scientific Application of IVDs
On 27 February 2019, the Russian Ministry of Health published a draft federal law (link in Russian) suggesting a potential new regulatory path for some in vitro diagnostics (IVDs) in Russia.
Thus, according to the document, IVDs that are developed, manufactured and applied in the laboratories or medical organisations engaged in scientific activity, may be allowed for use without registration upon condition that special five-year permits are obtained by the said medical/scientific organisation and the IVD product is included in the special register after the assessment procedure (expertise).
The draft document also describes control measures and algorithms of safety monitoring for such IVDs and the requirements for the medical/scientific laboratories that apply such products.
It should be noted that the registration procedure for all IVDs in Russia was simplified in June 2018; however, even today it still remains quite a long and complex process.
- New Version of the List of Medical Devices with Reduced VAT
On 15 March 2019, the Russian Ministry of Health published a revised version of the draft amendments to the list of medical devices exempted from VAT (link in Russian).
It should be recalled, that a single list of medical devices with a reduced VAT rate was approved by the Russian government in the Resolution 1042 in September 2015; however, since January 2017, after the entry into force of the new Russian classification system some of the medical devices (for example, some cardiac pacemakers, computer tomography, electrocardiography, and pieces of ultrasound and laser equipment) on the list were changed into categories that in practice do not have tax preferences. The published draft with a new version of the list based on a new classification system contains new codes and is intended to remedy this situation.
This is my short selection of highlights on medical device regulation changes and trends across Russia and the Eurasian Union for the last month:
- Medical Device Identification Requirement Initiative in Russia
The Russian law No. 488 (link in Russian), enforced in December 2018, gave the Russian government the right to approve the lists of goods subject to mandatory labelling/marking with additional means of identification. The objective of this initiative is to counteract the turnover of counterfeit products on the market.
Before 2019, the product labelling/marking initiative worked in experimental mode involving fur products (since 2016), medical drugs (since February 2017), and alcohol and tobacco products (since 2018). This year, Russia is also planning to gradually introduce the requirement of mandatory identification labelling/marking on other types of goods.
On 7 February 2019, the Russian medical device regulator Roszdravnadzor reported that the draft document on mandatory marking of medical devices has been prepared by the regulator and will be published in the near future. According to the regulator, the new requirements have been prepared ‘in line with the latest international requirements and on analogy with UDI’ in order to ensure traceability and to adequately identify medical devices through their distribution and use in Russia.
Multiple Changes in Medical Device Regulations in Kyrgyzstan
On 14 February 2019, the decree No. 311 of the Government of Kyrgyzstan ‘On certain aspects related to the registration of medical devices’ (link in Russian) came into force and introduced multiple changes in the medical device regulation in the country.
Thus, new local medical device registration rules (link in Russian) were implemented. According to the new rules, the medical device registration process takes up to 90 days and consists of a two-step examination: analytical expertise (this step is not required for medical devices approved in the European Union, Australia, Canada, Japan and USA) and specialised expertise completed with manufacturing site inspections in some cases.
In addition to the new registration rules, the enforced decree No. 311 accepts that classification of medical devices, as well as technical, biocompatibility testing and clinical trials for local registration, are conducted according to enforced Eurasian regulations.
Kyrgyzstan is a full-fledged member of the Eurasian Economic Union since 2015.
- IMDRF Meeting in Moscow
The fifteenth meeting of the International Forum of Regulators of Medical Devices (IMDRF), chaired by the Russian Federation, will take place on 18-21 March 2019 in Moscow for delegates from the medical devices manufacturing industry, research institutions, federal executive authorities, state institutions, foreign and international regulatory organisations. The open stakeholders forum will be held on 19 March 2019, with an agenda and registration details available on the IMDRF website and on the official web page of the event.
Thank you for following my blog, which is a non-commercial project with the aim to provide clear and up-to-date information about medical device regulations in Russia. You can also receive updates directly to your e-mail via the ‘Follow’ button on the toolbar of this page.
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.