About Alexey Stepanov

Medical Device Regulatory and Quality Professional based in Russia.

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

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




Dear Colleagues,

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

1. New Russian Import Procedures for Medical Device Samples

On 1 January 2021, the Russian healthcare regulator Roszdravnadzor enforced new procedures for the importing of samples for registration of medical devices in accordance with regulation #661n (link in Russian). Henceforward, an import permit is required both for registration and renewal procedures, and documents are submitted in electronic form only.

An import permit is still not needed for the accelerated registration of medical devices and in-vitro products intended for the prevention and treatment of the coronavirus under resolution #430.

2. New Post-Market Requirements for Medical Devices in Russia and Kazakhstan

On January 2021, Russia and Kazakhstan enforced new local post-market requirements for medical devices.

Russian Order #980n (link in Russian): ‘On the procedure for safety monitoring of medical devices’ applicable for medical devices registered in Russia. The regulation describes the criteria for monitoring events and procedure for work on a corrective action plan.

New Kazak regulation (link in Russian): ‘On pharmacovigilance and monitoring of safety, quality and officiate of medical devices’ was enforced early January 2021. The document provides a definition of adverse events, an example of the reporting form, a corrective-action report, and a field safety notice. The timelines for reporting were 2–30 days, depending on the severity of the event.

New requirements implemented in the regulation are mandatory post-registration clinical monitoring and submission of annual safety reports for class III devices and IIB implantable devices.

It is worth noting that both the above regulations apply to medical devices approved by local registration procedures. Meanwhile, post-market requirements for medical devices approved under Eurasian regulation are described in the Eurasian regulation #174.

3. New Registration Inspection Rules for Medical Device Manufacturers in Kazakhstan

On January 2020, Kazakhstan’s Ministry of Health issued new inspection rules for medical device manufacturers. This called for the registration of medical devices under local procedure (link to the regulation in Russian).

According to this document, the quality management system (QMS) inspection is mandatory for registering sterile IIa, IIb and III class medical devices. This applies to manufacturers or manufacturing sites unregistered in Kazakhstan before, or upon, the clinical-trial completion for all class III and class IIb implantable devices. The regulation describes the scope of the QMS inspection based on the international ISO 13485 standard. In certain cases, these new rules permit the remote inspection in form assessment of documents.


Russian and Eurasian Regulatory Roundup of 2020

Russian and Eurasian Regulatory Roundup of 2020

Dear Colleagues,

2021 is approaching, and in my usual December post, let me look back and summarise the highlights and major updates on medical device regulations in Russia and the Eurasian Union in the year 2020.

  1. Eurasian Medical Device Regulation Highlights 2020:

A year ago, on 31 December 2019, the Russian healthcare regulator Roszdravnadzor announced that the first medical device was approved under the Eurasian medical device regulations. The first Eurasian registration certificate was issued for a 2A class neonatal phototherapy lamp that was manufactured in Russia.

By the end of December 2020, there have been four medical devices (in-vitro devices) mentioned in the Eurasian database – all of these manufactured by Russian manufacturers. In the same database, we can also notice over 30 files submitted for Eurasian registration between 2019 and 2020 (with a significantly high rejection rate and a review time of over 350 days).

One of the key challenges for manufacturers (especially during the time of travel restrictions imposed during the pandemic) has been the necessity for carrying out an inspection of a manufacturing site to ensure compliance with quality management system (QMS) requirements (in accordance with the Eurasian Regulation #106). This compliance, as per regulations, is a mandatory step for approval of any medical device belonging to classes IIA and III. However, in September 2020, Roszdravnadzor announced that the first QMS inspection was carried out on the first medical device and that its approval was provided by complying with the Eurasian medical device registration procedure. Roszdravnadzor also announced that it carried out manufacturing inspection of two manufacturing sites located in Russia.

Most of the 1st, 2nd and 3rd level Eurasian regulations, nowadays, are released and approved by the Eurasian Commission. Some of the regulations that were updated over the course of 2020 include the amendment to the rules of registration and examination of medical devices (link in Russian), draft of a regulation on technical testing requirements (link in Russian), draft regulations on amendments to the criteria for classifying products as medical devices (link to the draft document in Russian).


According to Decision #142 (published in September 2019), the end of the transition period for submissions, according to local regulations of the Eurasian member states, as of today, still remains 31 December 2021.

  1. Russian Medical Device Regulation Highlights 2020:
  1. Response to COVID-19 – Russian and Eurasian Medical Device Regulations:

In the year 2020, the COVID-19 pandemic has overwhelmed the Russian healthcare system (which has been the case with other countries too). In response to the pandemic, Russian Ministry of Health introduced certain new regulatory measures and approval pathways related to medical devices and in-vitro diagnostics:

  • On 18 March 2020, the Russian government released Resolution #299 (link in Russian) followed by methodical guidelines (link in Russian) and opened a simplified registration route for 36 types of class I protective medical devices, including surgical or protective face masks, respirators, medical protective clothing, surgical suits, medical gloves, overshoes, etc. The official timeline for taking a decision on registration of products that are included in the list is within five days upon receipt of the registration file, on the condition that the manufacturer provides documents confirming the safety and quality parameters of these devices (testing and trial reports) within five months of the approval date. By the end of the year, the regulator announced that the initial registration of 1342 medical devices that were approved through the accelerated and simplified registration route were withdrawn since the required documents were not provided within the established deadlines.
  • On 6 April 2020, the Russian government released Resolution #430 (link in Russian) followed by guidelines (link in Russian)  and introduces simplified accelerated registration process for temporary approval of particular batches of 108 types of medical devices and IVD products included in the list (this list was extended to 363 types of products )that were intended for emergency usage in the prevention and treatment of coronavirus infection.
  • The temporary registration certificate (validity of which was prolonged until the end of 2021) of the product included in the list may be granted by Roszdravnadzor (within three business days) after carrying out testing through the special accelerated program).
  • By the end of December 2020, there will be over 300 registration records (for particular bathes) holding a temporary registration certificate in the Russian registration database.
  • Additionally, since April 2020, the regulator has allowed to sell imported disposable medical products included in the list (and not registered in the Russian Federation) on the condition that these products are registered in the specified manner outlined by the manufacturing country.

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    I would like to thank all of my subscribers and readers for showing your continuous interest and feedback  in my posts and updates. I wish you a wonderful holiday season! All the very best for the year 2021!

Three Things You Should Know about Medical Device Regulations in Russia and Eurasian Union, November 2020

Dear Colleagues,

Here is my usual selection of highlights to keep you in the loop regarding updates in Russian and Eurasian medical device regulations for the last month.

  1. Prolongation of the Simplified Medical Device Approval Process in Russia


On 13 November 2020, the Russian government released Resolution #1826  (Link in Russian) extending the validity of the simplified batch-by-batch approval process for medical devices and IVD products intended for emergency use in the prevention and treatment of coronavirus infection introduced in April 2020, for one year (i.e. until the end of 2021).

The published resolution can also extend the validity of licenses that were issued according to this simplified procedure, for particular batches of the products. However, this extension will require the procedure of the administrative replacement.

As of today, the simplified batch-by-batch approval process is valid for 363 types of medical devices, including some IVD assays and laboratory consumables, artificial ventilation machines and breathing circuits, connectors and valves for mechanical ventilation, pulse oximeters, patient monitors, medical furniture, protective masks and other medical devices and protective equipment. There are 278 registration certificates that were issued through this process.

2. Updated Procedure for Safety Monitoring of Medical Devices in Russia

On 2 November 2020, the Russian Ministry of Health published the Order #980n on the approval of the procedure of the safety monitoring for medical devices (link in Russian).
The regulation, that replaced the previous obsolete order cancelled in July 2020, comes into force on 1 January 2021 and will be applicable for medical devices approved according to Russian local procedure until 1 January 2027.

The Russian medical device regulation, requires licence holders to perform safety monitoring  by collecting information ‘on adverse effects not specified in the operating manual of the medical device, adverse reactions during its use, the peculiarities of the interaction of medical devices with each other, facts and circumstances that pose a threat to the life and health of citizens and medical workers during their use and operation.’

According to the document, the Russian medical device regulator may receive the information on adverse events from the reporting of manufacturers of medical devices, as well as by monitoring the post-market surveillance databases of regulatory agencies of other jurisdictions or control measures performed by the regulator.

Based on the information received during safety monitoring, the regulator may initiate additional control measures or request a plan of corrective action from the manufacturer.

3. Eurasian Criteria for Classifying Products as Medical Devices

On 24 November 2020, the Eurasian Commission published draft regulations on amendments to the criteria for classifying products as medical devices within the Eurasian Economic Union.  (link to the draft document in Russian)

The document proposes changes to existing criteria, issued in 2018 in Regulation #25, in order to eliminate differences in the requirements for classifying products as medical devices between the  Eurasian regulations and local regulations of the member states.
Most of proposed changes relate to standardising criteria for medical software with recently updated Russian requirements and some protective equipment.

The draft document is open for public discussion until 25 January 2021.

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Three Things You Should Know about Medical Device Regulations in Russia


Dear Colleagues, 

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

1. New Procedure for Importation of Samples of Medical Devices into Russia

On 30 September 2020, the Russian Ministry of Health published Regulation 661N (link in Russian) and updated the procedure for obtaining an importation permit and importing samples of medical devices for registration in Russia. 

The new regulation will go into effect in January 2021, and unlike the current procedure described in Regulation 7N, the entire new procedure will be completed only in electronic form.

The importation permit is required for bringing in samples of medical devices for preregistration testing. It will be required for any medical device made by a foreign manufacturer, except medical software. It will be issued free of charge by the regulator Roszdravnadzor within five business days and will be valid for one year.

The Regulation lists the documents required for obtaining an importation permit and the list of reasons for the rejection of a submission.

2. Updated Guidance on VAT Application for Medical Devices in Russia

On 19 October 2020, the Russian Ministry of Finance published letter N0307-07/90841 (link in Russian) and provided guidance on the application of value-added tax (VAT) exemption on the sale of medical devices and its components in Russia.

According to the document, exemption from VAT is applied on the conditions that there are registration certificates for the medical devices and that they are included in the list found in Resolution 1042.

If the components necessary for the intended use are sold together with medical devices and in the amount specified in the delivery set, then these components should be recognised as integral parts of medical devices and exempted from VAT.



3. Criteria for Humanitarian Use of Medical Products in Kazakhstan

On 14 October 2020, the government of Kazakhstan published Resolution 662 (link in Russian) and updated the list of cases when pharmaceutical products or medical devices are allowed to be imported into the country for humanitarian use.

The regulation allows importation – without the approval/registration by the Ministry of Health – of medical products for the prevention and elimination of the consequences of natural and civil emergencies, as well as during the start of a state of emergency; of medical products that are intended for prevention and treatment of especially dangerous infectious diseases; and of orphan (rare) diseases.

Three Things You Should Know About Medical Device Regulations in Russia, September 2020

Dear Colleagues,

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


1. Updated Criteria for Medical Devices Exempted from the Registration Requirement


On 1 September 2020 the Russian government released Resolution #1335 (link in Russian) and updated the criteria of medical devices that do not require registration in Russia. The regulator also harmonised these requirements with the Eurasian legislation.

Henceforward, the following medical devices are within the scope of this regulation:
–Medical devices that match the Eurasian criteria listed in Clause 4.11 of the Eurasian Agreement (including medical devices for personal use, medical devices for medical aid on transport or international cultural or sport events, as well as those imported for humanitarian use);
–Custom-made medical devices that are made and intended for a particular patient;
–Medical devices that are intended for use within the territory of the international medical cluster or innovative science and technology centres.

2. First Medical Device Passed Eurasian Quality Management Inspection

Russian healthcare regulator, Roszdravnadzor, announced on 16 September 2020 the approval of the first medical device according to the Eurasian medical device registration procedure including the completed manufacturing inspection of two manufacturing sites (located in Russia) for compliance with the quality management system requirements according to Eurasian Regulation #106.

It should be recalled that since March 2019, after a one-year transitional period, the quality management inspection system became a mandatory step for the Eurasian approval of medical devices of IIB–III risk classes; however, until today, many of the organizational and administrative requirements for such inspections, as well as the list of the organisations that conducted these inspections, were not clear.

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.

At the end of September 2020, there are four medical/in-vitro devices in the Eurasian database, all of them manufactured by Russian manufacturers.

3. Upcoming Deadline for the Administrative Replacement of the Obsolete Licences

In September, Roszdravnador reminded the industry that Russian registration certificates for medical devices issued before 2013 and having unlimited validity must be updated according to the special administrative replacement procedure by 1 January 2021; otherwise, after this deadline these licences will be annulled by the regulator.

The requirement to update old licenses was introduced in 2013, when Russia enforced a new medical device regulation system, and, after that, in 2017 the deadline for replacement was prolonged until 2021;

A detailed description of the replacement procedure is provided on the official site of Roszdravnadzor (in Russian) or here.

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Thank you for following my blog, which is the aim of providing timely and clear updates on the development of Russian and Eurasian medical device regulations. For Russian and Eurasian updates you might also be interested in my upcoming seminar or presentation on the MedTech summit.

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union – August 2020

Welcome to my monthly review of the most important updates to medical device regulations in Russia and the Eurasian countries.

 

  1. Development of the Regulations for Software as a Medical Device (SaMD) and Artificial Intelligence

On the 10th August 2020, the Russian Ministry of Health published order #686N (link in Russian) and updated the algorithm for the classification and registration of SaMD.

In addition, in early August 2020, the Russian Ministry of Health published two draft regulations:

  • An amendment to the rules governing the state registration of medical devices (link in Russian) suggesting an accelerated approval process (a one-step registration instead of the current two-step process) for SaMD, including software that uses ‘artificial intelligence technologies’.
  • An amendment to the requirements for technical files and the instructions for their use (link in Russian), providing specific requirements in relation to the technical files for SaMD.

It is interesting to mention that at the end of July 2020, the Russian Ministry of Health announced that work to improve the standards of artificial intelligence in healthcare was underway, and in the last month it has been revealed that a first draftof the national standard on clinical trials for systems with artificial intelligence has been published.

Regular readers might also recall that in June 2020, the Russian healthcare regulator Roszdravnadzor published the updated guidelines (national methodical recommendations) for the registration of SaMD in Russia (link in Russian).

The accelerated approval process for the registration of low-risk medical devices (class I) and in vitro diagnostics was implemented in Russia in 2018.

  1. List of Medical Devices Containing Ethyl Alcohol

On the 26th August 2020, Roszdravnadzor published (link in Russian) a list of 41 medical devices containing ethyl alcohol that are excluded from general alcohol regulations in Russia, such as Federal Law 171. The production, importation and circulation of these products will not be covered by the federal law on the regulation of ethyl alcohol and thus will not require additional licenses or permits.

According to the current procedure, this list is created using applications from manufacturers, or their authorized representatives, submitted to Roszdravnadzor between the 1st of January and the 30th of June each year, and subject to rules that came into effect in 2019.

It should also be noted that Russian legislation specifies that any medical device in liquid form containing ethyl alcohol (ethanol) should be subject to additional specific regulation.

  1. Eurasian Update

On the 3rd August 2020, the Eurasian Commission published a draft regulation with an amendment to the rules for toxicology (biocompatibility) testing of medical devices for Eurasian registration (link to the draft in Russian).

This document included updates to the testing requirements and the description of the testing procedure. The regulation also updated the criteria for the inclusion of testing laboratories into the unified Eurasian database.

For the end of August 2020, according to the official website of the Eurasian Commission, there were three medical devices approved using the Eurasian procedure with more than 20 applications for Eurasian registration submitted by manufacturers over the last year, and 23 laboratories now accredited to perform the testing.

 

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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 to your email via the ‘follow’ button on the toolbar of this blog.

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, July 2020

 

Dear colleagues,

Let me summarise the most important news and updates from the Russian medical device regulatory landscape in July 2020.

  1. Russia Abolished Certain Excessive Medical Device Regulations 

On 4 July 2020, the Russian government published the Resolution 982 (link in Russian) and, in the framework of the so-called ‘regulatory guillotine’, abolished some of the national medical device regulations. 

The most serious changes affected Russian post-market requirements for medical devices (i.e. the cancellation of Regulation 12N on adverse event reporting and Regulation 175N on safety monitoring) and their exclusion from the list of products requiring a GOST certification. 

The published resolution also abolished the regulation on the licensing of manufacturing and technical maintenance of medical equipment and the rules regarding the destruction of counterfeit medical products.

In addition, it will cancel 11 other minor regulations affecting medical devices, starting in January 2021. 

Later, on 29 July 2020, the Ministry of Health published a new draft of a regulation on medical device safety reporting (link in Russian) intended to replace the cancelled regulation. 

The ‘regulatory guillotine’ initiative was announced by the Russian government in 2018 as a measure to cancel the regulatory acts that are no longer effective for the excessive and inefficient regulation of business.

  1. Updated Medical Device Examination Requirements in Russia and Kazakhstan

On 24 July 2020, the Russian Ministry of Health released an updated version of the regulation on the examination of medical devices for their state registration (link in Russian), which replaced its obsolete version.

The document reflects recent changes in higher-level regulations and describes the examination procedures of medical devices (as a part of the registration process) depending on the class of the device or/and the type of submission (e.g. registration of low-class devices, in-vitro diagnostics; accelerated track for medical devices included in the emergency list; examination processes for registration renewals).
Similar changes have recently been implemented in Kazakhstan. The new version of the examination rules, released on 10 July 2020 (link in Russian), allows registration approvals without quality inspections of the manufacturers or/and type testing at the manufacturing sites as a response to the pandemic.

  1. Eurasian Technical Testing Requirements Updated and theSecond Product Approved

On 10 July 2020, the Eurasian Economic Commission published a draft of a regulation on technical testing requirements for Eurasian registration procedures (link in Russian).

The draft clarifies the testing procedures of medical devices for Eurasian registration and the requirements for the accreditation of testing laboratories.

As it was stated in the previous version of the regulation, the objective of technical trials is to demonstrate conformity to Eurasian essential safety and efficiency requirements and standards. The regulations allow testing one ‘typical model’. In cases of groups of similar products and of capital equipment, technical testing may be performed in the countries where the devices are installed. Technical testing is not required for in-vitro diagnostics.

At the end of July 2020, two medical/in-vitro devices have received Eurasian approval.

Three Things You Should Know About Medical Device Regulations in Russia, June 2020

 

 

Dear Colleagues,

Here is my usual list of highlights on the updates and developments of medical device regulations in Russia:

  1. Expanded List of Medical Devices for Accelerated Registration

On 2 June 2020, the Russian government released the Resolution #804 (link in Russian) and expanded the list of medical devices falling under the simplified accelerated registration process of medical devices and in vitro products intended for emergency use in the prevention and treatment of coronavirus infection (introduced in March 2020). The temporary registration certificate (valid until the end of 2020) for particular batches of such devices may be granted by the Russian healthcare regulator, Roszdravnadzor, within three business days after submission of the dossier.

As of today, there are 363 types of medical devices in the Resolution #804 list, including some IVD assays and laboratory consumables, artificial ventilation machines and breathing circuits, connectors and valves for mechanical ventilation, pulse oximeters, patient monitors, medical furniture, protective masks and other medical devices and protective equipment.

Single-use medical devices included in the list may be imported into Russia and put on the market without registration in the condition they were approved in their country of origin, and information on batches imported into Russia is submitted to Roszdravnadzor.

The resolution also provides the new procedure for the renewal and amendment of temporary registration certificates.

  1. Updated Guidelines for Medical Software Registration in Russia

On 9 June 2020, Roszdravnadzor published the updated guidelines (national methodical recommendations) on the registration of software as a medical device in Russia (link to the document in Russian).

The document contains criteria on which software may be considered a medical device (with examples), a classification algorithm with a reference to the Russian GOST standard, requirements on technical documentation for software in Russia, references to the legislation on personal data and other legal requirements, as well as an algorithm for technical testing, clinical trials and assessment by the competent authority.

To be recalled, that on February 2020, Roszdravnadzor already published the letter clarifying some of these topics.

  1. Batch Notification Requirement for Medical Device Importers in Russia

A relatively new initiative for medical device regulations in Russia is the requirement of manufacturers and importers to notify Roszdravnadzor of every series and batch of medical devices imported and circulated in Russia. The order to introduce the draft law ensuring this requirement by 15 July 2020 was done by the Russian President, Vladimir Putin, on 24 June 2020. According to the order, a data analysis should be done for information on monitoring the safety of medical devices (post-market surveillance).

 

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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. You can receive my regular updates directly to your email via the ‘follow’ button on the toolbar of this blog.