Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, November 2021

Dear Colleagues, 

Welcome to my monthly review of regulation changes regarding medical devices in Russia and the Eurasian region.

  1. Eurasian transition in less than a month

In less than a month the transition period will end and the complete switch to the Eurasian medical device regulations will come into effect. Applications for registration of medical devices under national requirements for Russia, Belarus and Kazakhstan will be closed. From 1 January 2022 all medical devices must be registered solely according to the laws of the Eurasian Economic Union (EAEU). 

After the five-year transition period, very limited practical experience of working under the new requirements has been acquired:As of November 2021, the Eurasian Commission (EEC) listed seven approved medical devices on its official register, and more than 30 applications are currently under review by the Eurasian member states.

It should be recalled that Eurasian Regulation #142 (link in Russian) dated September 2019, Eurasian Regulation #20 (link in Russian) dated 21 October 2021 and Russian Regulation #2081 (link in Russian) dated July 2021 established the following requirements for this transition:

-Submissions for registration and expertise of medical devices (according to national procedure in Russia, Belarus, Kazakhstan and Kyrgyzstan) are permitted until 31 December 2021.

-Medical devices approved under local registration systems in Eurasian member states by 31 December 2021 may keep this status in the member state until the registration expires, with the possibility of amendment according to the national rules, which are valid till 31 December 2026.

If submitted before 31 December 2021, the registration dossier will be reviewed according to the local registration rules of the member state in question.

As of the end of November 2021, no other official updates on changes, extensions or exemptions to the requirements were published. However, the requirements should also be ratified by all Eurasian member states.

2. Mandatory Notification on All Imported Medical Devices in Russia

On 25 November 2021, the Russian ministry of health published a regulation # 11020 (link in Russian) and established since 1 March 2022 a mandatory requirements for notification on every unit of any medical device imported in Russia or manufactured within the country for the purpose of safety monitoring by the regulator. According to the document, information on the name of the medical device and its modification, its serial number, its manufacturing and expiration date and the number and date of registration should be submitted using the Roszdravnadzor electronic system (Russian medical device regulator) within fifteen days after importation or manufacturing release.

3. Requirements on certain in-vitro diagnostics products 

On 2 November 2021, the Russian ministry of health published Order #1031N (link in Russian), which approved the procedure for the manufacture, storage and disposal of certain medical devices for in vitro diagnostics (IVD) (i.e. ‘in-house/home-brew’ IVD assays) developed and manufactured by individual laboratories.

It should be recalled that, according to the regulations accepted in July 2021, certain products may undergo an accelerated approval process to receive a special five-year permit for clinical/diagnostic use, in particular laboratories without registration of a product. 

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, October 2021

Dear Colleagues, 

Welcome to my monthly review of medical device regulatory changes in Russia and the Eurasian region:

1. New rules for Russian state register of medical devices

On 30 September 2021, the Russian government released Resolution 1650 (link in Russian), ‘On approval of the Rules for maintaining the state register of medical devices’, which, since 1 March 2022, implements new requirements for the Russian state register (the database of approved medical devices).

According to the published regulation, in addition to the information, which is currently available in the database, the updated state register will contain registered instructions for use, photos of the device or software interface as well as information on analogue (substitutable) medical devices.

2. Prolongation of the accelerated registration routes for medical devices intended for diagnosis and treatment of COVID-19

On 28 October 2021, the Russian Ministry of Health released draft amendments (link in Russian) to Resolution 430, which suggested prolonging, from 1 January 2022 to 1 January 2025, the validity of registration certificates for particular batch/lots if the medical devices and in vitro products were intended for diagnosis and treatment of COVID-19. Such certificates were issued according to the accelerated registration procedure. For such a prolongation of the licenses, the registration holder has to submit documents for the procedure of administrative replacement by 1 January 2022.

It should be noted that, for the end of October 2021, there are more than 600 registration certificates in the national database that were issued according to this route and potentially may be prolonged.

The same published draft document extends the possibility of submitting new batches of medical devices for the accelerated registration procedure to 1 January 2025 (instead of 1 January 2022), regardless of the approaching transition to the Eurasian medical device registration system.

In addition, the published regulation expanded, from 360 to 470, the list of medical device products intended for emergency use in the prevention and treatment of coronavirus infection, which fall under the simplified accelerated registration process.

3. New state fees for registration of medical devices in Russia and the Eurasian Union

At the end of September 2021, the Russian government released a draft amendment to the Russian tax code (link in Russian) suggesting an increase in the level of state fees for registration of pharmaceutical products and medical devices in Russia and the Eurasian Union, as of the beginning of 2022.

According to the document, the new amount for registration expertise will vary, depending on the risk class of the medical device, from 72,000 to 184,000 rubles (app. 1,000–2,500 USD). The level of expertise required for amendment of the registration certificates will incur a cost also, from 32,000 to 104,000 rubles (app. 500–1,500 USD).

The fees for the new procedure for getting authorisation for use for certain non-registered in vitro products is expected to be 65,800 rubles (app. 1,000 USD).

According to the published draft regulation, the same level of fees will apply for the expertise and acceptance procedures for Eurasian medical device registration.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, September 2021.

Dear colleagues,

Here is my update on the Eurasian Economic Union’s (EAEU) medical device regulations for the last month:

  1. Revision of the EAEU’s Medical Device Registration Rules

On the 21st of September 2021, the Eurasian Economic Commission (EEC) released regulation 148 (link is in Russian) with an updated revision of the EAEU’s medical device registration rules where they implemented significant changes in its requirements. These changes included the option to register several medical devices with different EAEU codes at once, a change of the established timelines for the steps of approval, updates regarding the procedure of amendment of the registration certificate and clarification on the quality management system inspection procedure.

Earlier, on the 13th of September 2021, the EEC released regulation 22 (link is in Russian) with a guide for inspection bodies of the Eurasian member states (EAEU inspectors)  to conduct inspections/audits of a medical device’s manufacturers’ quality management system.

As of the end of September 2021, seven medical devices have been approved under the EAEU rules.

  • Authorisation for Emergency Importation of a Medical Device for Individual Patients in Russia

On the 22nd of September 2021, the Russian Government released resolution 1590 (link is in Russian). This opens the possibility to receive authorisation for emergency importation of medical devices for particular named patients in the case of a life-threatening medical emergency in Russia. Until this moment, this type of emergency importation was not regulated in Russia.

According to the published procedure, this authorisation is valid for 30 days and should be issued by Roszdravnadzor, the Russian medical device regulator, within five business days after the electronic submission of a dossier. A dossier should include the relevant medical justification on behalf of the clinic, identification documents of the patient, the relevant translated instructions for use or user manual and photos of the medical device.

This law will be implemented on the 1st of March 2022 and will be valid until the 1st of January 2027.

  • Updates of the Local Medical Device Registration Procedure in Belarus

On the 1st of September 2021, the government of Belarus released resolution 504 (link is in Russian) updating local medical device registration rules.
The main changes made are related to the registration requirements of medical devices that are needed for urgent needs , used to provide humanitarian aid and supplied by public health organisations as part of international health programs. This resolution also implemented updates on the registration renewal procedure.

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Thank you for following my blog which aims to provide clear and timely updates on the development of the EAEU’s medical device regulations. Let me also remind you that you can receive updates directly to your email via the ‘follow’ button on the toolbar of this blog.

Three Things You Should Know about Medical Device Registration in Russia and the Eurasian Union in August 2021

Dear Colleagues,

Welcome to my monthly review of the most important updates in medical device regulations in Russia and Eurasia:

  1. Strengthening of Import-Substitution Policy for Certain Medical Devices in Russia

On 28 August 2021, the Russian Ministry of Industry and Trade issued Resolution #1432 (link in Russian), which significantly strengthens restrictions on public procurements for a range of over 170 groups of electronic equipment, including more than 30 groups of medical devices manufactured by foreign companies.

The resolution introduced the so-called ‘second odd one out’ rule, which requires public customers procuring products listed in the resolution to reject bids from foreign manufacturers if there is already one (or more) bids for the supply of the same product manufactured in the Eurasian Union. For the medical devices listed in this document, this requirement will replace the similar ‘third odd one out’ rule, introduced by Resolution #102 in February 2015.

In addition, the new regulation requires public customers to obtain permission from the Ministry of Industry and Trade to purchase imported products on the new list.

Resolution #1432 will affect computer tomography, mammography and certain other X-ray machines, certain endoscopic equipment, individual glucometers and glucose analysers, heart rate monitors, ultrasound equipment, inhalation anaesthesia machines and ventilators and some other groups.

2. Russian Regulator Updated Requirements for Importation of Non-registered Medical Devices in Russia

On 9 August 2021, the Russian government issued Resolution #1321 (link in Russian), specifying requirements for importing non-registered medical devices into Russia and the Eurasian Union. These requirements will apply to custom-made medical devices intended for personal use, medical devices imported for research and scientific purposes, medical devices intended for medical assistance during international cultural and sporting events, trade exhibitions and other cases.

According to the published regulation, such imported devices must be reported to Roszdravnadzor via electronic system within three business days.

Regulations allow for the transportation, storage, installation, adjustment, use, operation, maintenance and repair of such non-registered devices, as well as their disposal, destruction and export from the country.

The new order will go into effect on 1 March 2022 and will be valid until 1 January 2027.

3. Updates on Development on Eurasian Medical Device Regulations

There have been several updates to Eurasian medical device regulations over the last month:

At the end of July 2021, the Russian government confirmed (link in Russian) amendments to the Eurasian agreement on common principles of circulation of medical devices regarding deadlines for the end of the transition period, as previously proposed:

-Submissions for registration and expertise of medical devices according to local rules (of the Eurasian member states) will be open until 31 December 2021.

-If submitted before 31 December 2021, the registration dossier will be reviewed according to the local registration rules of a member state.

-Medical devices approved under the local registration system in Eurasian member states may remain approved in this member state until the registration expires.

-Registration certificates for medical devices registered according to the local rules may be amended (under local rules) until 31 December 2026.

Meanwhile, there is a discussion in the Russian media about a petition from manufacturers and Russian distributors regarding the possibility of extending the submission deadline based on current national requirements.


 On 6 August 2021, the Eurasian Commission published a draft amendment to Eurasian Decision #106 ‘On the requirements for the quality management system for medical devices manufacturers’ (link in Russian), suggesting several updates on the status of the inspection body that performs the audit inspection.

As of the end of August 2021, seven medical devices have been approved under Eurasian rules.

Three Things You Should Know about Medical Device regulations in Russia July 2021

Dear colleagues,

Here is my usual selection of highlights in medical device regulatory updates in Russia over the past month:

1. Implementation of new post-market control measures for medical devices in Russia

On 30 July 2021 the Russian government released Resolution 1066 (link in Russian) and implemented new regulations which significantly changed control measures for organizations involved in the turnover of medical devices in Russia (including manufacturers, distributors and customers [medical centres]).

The document implemented changes in the forms and schedules of the control inspections performed by the regulator. The scheduled inspections will be carried out every 4 to 6 years, depending on the risk classification of the organization, and will not be needed for organizations in low risk groups.

In addition to planned inspections, the document introduced additional control measures such as inspection visits, test purchases and random sample checks of medical devices.

2. Update on quality management system requirements for medical device manufacturers

In July 2021 the Russian government released two draft guidelines on the quality management system (QMS) requirements for medical device manufacturers.

The draft regulation “on requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on their risk classification” (link in Russian) provides a description of the scope of the QMS assessment including design and development, processes for managing documents and records, final inspection processes, corrective and preventive action, and customer-related processes.

The document refers to Russian standard GOST ISO 13485-2017 and Eurasian Decision #106 as guidelines for implementation of the QMS.

Another document published in July 2021 is a draft regulation on conducting QMS inspections of medical device manufacturers (link in Russian).

The published guidance provides differentiation between three types of QMS audits:
1. Initial QMS inspections that must be performed for all manufacturing sites mentioned for registration application.
2. Scheduled regular QMS inspections that must be performed every 5 years for manufacturing sites selected by the regulator.
3. Unplanned QMS inspections that must be performed in certain cases of registration amendments or after completion of corrective actions.

The draft document provides a matrix for the assessment of the significance of the observations recorded during an inspection, which, according to the rules, must be closed within 30 days of the audit.

The document also provides guidance on calculating the duration of an audit, which may vary from 6 to 13 days depending on the headcount of the manufacturing organization. However, the entire inspection process may not exceed 90 days from the submission of the application.

There are several cases for which the regulations allow performing a QMS audit remotely, conditional upon performing an on-site audit within 2 years

3. New regulatory requirements for certain in-home in-vitro diagnostics

On 15 July 2021 the Russian Ministry of Health published a draft regulation (link in Russian) describing new potential approval routes for, as well as regulatory requirements of, certain in-vitro diagnostic (IVD) products (i.e. ‘in-house/home-brew’ IVD assays) developed and manufactured by individual laboratories.

According to the draft regulations such products may undergo an accelerated approval process via the obtainment of a special 5-year permit for clinical/diagnostic use in particular laboratories without registration. The document provides a detailed description of the approval procedure and requirements for submission of an application package.

The procedure is expected to be applicable for IVD products without registered analogue in Russia both made and intended for use by a specific laboratory or organization and will consider an assessment of the financial cost of registration and any existing need for diagnostics using the product.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Economic Union, June 2021.

Dear Colleagues,

Please find below my usual selection of the latest updates in medical device regulations in the Eurasian Economic Union (EAEU):

  1. Updates to the List of Eurasian Medical Device Standards

On 8 June 2021, the Eurasian Economic Commission published recommendation #10 (link in Russian) and updated the Eurasian list of standards for demonstrating compliance with essential principles of safety and efficacy of medical devices in the EAEU.

According to the published document, nine existing standards were replaced with more up-to-date versions; eight new standards and one measurement procedure were added, and seven outdated standards were excluded from the current version of the list.

The list of applicable standards to ensure compliance with essential principles of safety and efficacy of medical devices in the EAEU is a ‘third-level’ Eurasian regulation. It was initially published in 2017 and intended to harmonise existing national standards of the Eurasian member states and correlate them with the relevant requirements of the Essential Checklist for voluntary use by manufacturers and testing laboratories during the Eurasian registration process.

  1. Classification of Adverse Events of Medical Devices in Russia

At the end of May 2021, the Russian healthcare regulator Roszdravnadzor released order 4513 (link in Russian) and implemented the classification of adverse events related to the circulation of medical devices.    

The classification contains 27 groups and characterises each of the adverse events that may arise (mechanical, chemical, optical problems, compatibility inconsistency, connection, interaction with the external environment, etc.).

It should be remembered that Russian medical device regulations require monitoring and reporting of medical device adverse events that occur both in Russia and in other countries.

  1. Changes in Tax Regulations for Certain Groups of Medical Devices in Russia

On 1 June 2021, the Russian government published Resolution 851 (link in Russian) and updated the list of medical devices taxed at a decreased rate of 10%, approved by Decree of the Government of the Russian Federation N 688. According to the published document, particular in vitro culture mediums, containers for medical wastes, specific urology devices and medical clothes were included on this list.

Later, on 25 June 2021, the Russian Ministry of Finance gave some clarifications regarding the application of tax preferences on sales of medical devices after switching to the Eurasian system. According to the published letter (link in Russian), the sale of medical devices at the reduced tax rate using a Russian registration certificate will be possible until 31 December 2021. However, according to the same document, the Ministry of Health has already prepared a draft federal law on the abolition of this limitation.

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Thank you for following my blog, which aims to provide timely and clear updates on the development of Russian and Eurasian medical device regulations. You may also be interested in my upcoming seminar on this topic, scheduled for July 2021.

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union in May 2021

Dear Colleagues,

Here is my usual list of highlights on the updates and developments regarding medical device regulations in Russia and the Eurasian region over the last month:

1.Russia Updated Assessment Requirements for Software as Medical Device

On 26 May, 2021, the Russian Ministry of Health published the Oder #386N (link in Russian) and updated the algorithm of registration expertise for software as a medical device (SaMD) previously proposed in July 2020.

Among other updates, the published regulation proposed a one-step assessment process (similar to the current assessment pathway for low class devices and IVDs) and also emphasised mandatory requirements for providing for the assessment of the photos of the user interface and carrier of the SaMD.

It should be recalled that the national rules for registration of the SaMD, as well as requirements for the technical file and instruction for use, were updated in a similar way at the end of 2020.

2. Requirement on Notification of Imported and Manufactured Medical Devices in Russia

On 14 May, 2021, the Russian Ministry of Health published a draft regulation (link in Russian) suggesting mandatory requirements for notification on every unit of any medical device imported in Russia or manufactured within the country for the purpose of safety monitoring by the regulator. According to the document, information on the name of the medical device and its modification, its serial number, its manufacturing and expiration date and the number and date of registration should be submitted using the Roszdravnadzor electronic system (Russian medical device regulator) within five days after importation or manufacturing release.

Another draft regulation published over the last month suggested a similar notification requirement for a medical device not requiring registration (link in Russian) and proposed mandatory notification for medical devices imported without registration for humanitarian, research or exhibition purposes; the same informational system would be used.

In this context, it should be also recalled that the requirement for mandatory notification on imported medical devices and in-vitro diagnostics intended for emergency usage in the prevention and treatment of coronavirus infection and approved in Russia according to accelerated procedure has been in effect in Russia since April 2020.

3. Uzbekistan will Recognise International Medical Device Approvals

There is interesting news from Uzbekistan. On 5 May, 2021, the government of the country released the order # УП-№6221 (link in Russian) and introduced the procedure of recognition of approvals for medical devices made by major international regulatory agencies.

According to the released document, since 1 June, 2021, all medical devices approved by the US FDA, European notification bodies, MHRA (UK), PMDA (Japan) or MFDS (Korea) will undergo a fifteen-day acceptance process without laboratory testing in the country.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, April 2021

Dear Colleagues, 

Welcome to my monthly review of medical device regulatory changes in Russia and the Eurasian region:


1. Suggestions for Multiple Amendments to Russian Medical Device Regulations

In April 2021, multiple amendments made to Federal Law #323 ‘On health care protection’, related to the regulation of medical devices, were discussed by the Russian parliament. The published draft law (link in Russian) related to this initiative, among others, proposed the following significant changes to Russian medical device regulations:

– to amend the list of cases where medical devices are not subject to state registration;

– to implement the procedure for approving the classification of adverse effects of monitoring the safety of medical devices;

– to clarify the definition of ‘poor quality medical device’;

– to establish requirements for the implementation, maintenance and assessment of a quality management system for the production of medical devices;

– to establish a requirement to reissue licenses for the technical maintenance of medical device manufacturers by 31 December 2022;

– to grant the possibility of circulation of medical devices according to technical documentation in cases when registration certificate is expired and after 180 days in case of amendment of the registration certificate.

At the end of April 2021, the document was approved by the Russian parliament and signed by the President, although it has not yet come into force.

2. Discussions on the Simplification of Registration for Russian Manufacturers

Another initiative that was discussed and proposed by the Russian government over the last month was draft regulations (link in Russian), suggesting the simplification of the national registration process (an accelerated one-step registration) for Russian manufacturers. This would be on the condition that performance type testing, overseen by Russian healthcare regulator Roszdravnadzor, is carried out in the testing lab of the expert body.

The same draft proposed the possibility of two additional request/deficiency letters from Roszdravnadzor during the national Russian registration procedure (instead of one request as it stands currently) to minimise the possibility of registration rejections.
By the end of April 2021, the document had reached public discussion.

3. Development of Regulations on Remote Quality Management Audits for Medical Device Manufacturers

On 30 April 2021, the Eurasian Commission published a draft document (link in Russian) on the amendment of the Eurasian Requirements for Quality Management Systems for Manufacturers of Medical Devices (which were previously implemented in the Eurasian Regulation #106).

According to the proposed amendments in the draft document, the quality management audit (required for Eurasian approval of medical devices classed as high risk) may be performed in remote mode with approval from the regulator and on the condition that there will be a standard audit within two years of the virtual inspection.

The draft document is expected to be in public discussion until the end of May 2021.

Earlier in April 2021, the Russian Agency on Technical Regulating and Metrology released the national standard GOST 59424-2021 with guidelines for performing remote analysis of the management system.

The QMS audit is a mandatory step for the approval process of IIb and III class devices, according to Eurasian regulations. Due to travel restrictions caused by the pandemic and a lack of clear guidance, however, switching to Eurasian approvals remains highly uncertain for manufacturers. 

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, March 2021

Dear Colleagues,

Here is my regular update on the Russian and Eurasian medical device regulations for the last month:

  1. Update on the Eurasian Transitional Period

On 9 March 2021, the Eurasian Commission published Regulation No.28 (Link in Russian) which confirmed and specified deadlines for the Eurasian regulation transition period previously established  as follows:

  • Submissions for registration and expertise of medical devices according to the local rules (of the Eurasian member states) will be open until 31 December 2021.
  • If submitted before 31 December 2021, the registration dossier will be reviewed according to the local registration rules of a member state.
  • Medical devices approved according to the local registration system in the Eurasian member states may stay approved in this member state by the end of validity of the registration.
  • Registration certificates for medical devices registered according to the local rules may be amended (by the local rules) by 31 December 2026.

On 22 March 2021, the Russian Ministry of Health published the draft of amendments of the rules for the state registration of medical devices in Russia (link to the draft in Russian), harmonised with Eurasian regulations and transition deadlines and proposed other amendments. The draft is currently in the discussion stage until 9 April 2021.

Regardless of the approaching end of the transition period, we still may see a limited number of submissions and approvals according to the new Eurasian system.  As of the end of March 2021, there are five records concerning approval of medical/in-vitro devices in the Eurasian Union. All approved devices are manufactured by Eurasian manufacturers.

  1. Extension of the Restriction List for Medical Devices in Russia

On 6 March 2021, the Russian Government released Resolution No.336 (link in Russian), which expanded the list of medical devices originating from foreign countries, subject to restrictions for state and municipal procurements according to Resolution #102.

The new devices added to the restriction list include biochemical analysers, fetal monitors, medical, biological, and clinical microscopes for laboratory diagnostics, ultrasound surgical devices, surgical coagulants, and therapeutic laser devices.

According to Resolution #102, participation in government and municipal tenders for the supply of these products must be rejected if at least two suppliers from Russia or the EAEU countries take part in the auction with a similar type of product.

  1. Kazakhstan Updated Labelling and Advertising Requirements for Pharmaceutical Products and Medical Devices

At the end of February 2021, the Ministry of Health of Kazakhstan released order #KR-DCM -11 (link in Russian) and updated national requirements for the labelling of medical devices. The regulations provide a list of information and symbols required for the manufacturer to state on the label of a medical device. The labelling must be present in Russian and Kazak languages, approved by the competent authority during the registration process and attached to each unit.

Previously, in January 2021, the Ministry of Health of Kazakhstan enforced the order #KR-DCM -11 (link in Russian) and updated rules for advertising medical devices in the country.

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Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, February 2021 

Dear colleagues, 

This is my usual selection of the highlights from the medical device regulatory landscape for Russia and the Eurasian Union over the last month

  1. Update on the Requirements for State Procurements for Medical Devices Containing Plastic Materials in Russia

    On 28 January 2021, the Russian government released Resolution #76 (link in Russian), which updated the criteria for the restrictions for public and municipal procurement for single-use medical devices made from poly-vinyl chlorides (PVC). Since 2017, these types of devices have been subject to restrictions (in certain conditions) for government procurements, according to List #2 of the Resolution #102.

    The published document extended the scope of the resolution to medical devices made not only from PVC but also from other plastic materials and introduced the localisation indicator of the production of medical devices included in the list.
    For the end of February 2021, List #2 for the Resolution #102 contains over 100 types of PVC and plastic medical devices, which are classified into six groups.

  2. Update on the National Medical Registration Rules in Kazakhstan

    Kazakhstan constantly updates the local medical device regulations, as follows:

    The updated version of the 735 Regulation (link in Russian) allowed a registration certificate to be obtained for a medical device with an unlimited validity period after the first submission.

    The updated version of the 736 Regulation (link in Russian) simplified the registration procedure for medical devices manufactured in the European Union, United States of America, Canada and Japan, and at the same time, was approved by the regulatory agencies of the aforementioned countries. Henceforward, these devices may skip the laboratory testing stage for the registration expertise.
    The same regulation has also updated the conditions for the accelerated 30-day registration pathway for medical devices for COVID-19 emergency use – henceforward, these procedures may only be applied after preliminary approval by the regulator.

    The Order#  282/20 (link in Russian), which was released in December 2020, updated the requirements for the procedure of the safety and quality assessment for medicinal products and medical devices in Kazakhstan via the declaration procedure.
  1. Renewal of Certain National Standards Related to Medical Devices in Russia:

Over the last few months, several national GOST standards, which are applicable to different types of medical devices in Russia, have been updated as follows:

In January 2021, certain parts of the national standard for electrical requirements for blood circulation monitors and ultrasound equipment and the national standard for needles colour coding were renewed.

From March 2021, the following renewed versions of the standards will come into force:
– General technical requirements for medical devices (GOST 50444-2020);

– Certain parts of the national standard on biocompatibility assessment (GOST ISO/TR 10993);

– New versions of the standard for technical requirements and the assessments for an endoscopy GOST 58936-2020 and MRI equipment GOST 59092-2020.


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I would like to thank LIMI Consulting for the continuous support and updates on Kazakhstan that I used in my review.