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, 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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Three Things You Should Know about Medical Device Regulations in Russia, May 2020


Dear Colleagues,

Here is my usual selection of highlights to keep you in the loop regarding updates in Russian medical device regulations:

  1. Accelerated medical device approval tracks in Russia

As you are probably aware from my previous updates,  two accelerated pathways for approval of medical devices were introduced in Russia in response to the coronavirus pandemic over the last few months:

  1. An accelerated track for 36 types of low class medical devices included in the list under Resolution #299 (link in Russian).
  2. Accelerated track for particular batches  for 108 types of medical devices and in-vitro products intended for emergency use in the prevention and treatment of coronavirus infection. The relevant devices are listed under Resolution #430 (link in Russian).

As of 29 May 2020, according to the official database of registered medical devices , there are at least 48 assays for diagnostics of coronavirus infection (molecular assays for detection of the virus and immunochemistry assays for antibody detection) approved in Russia (both accelerated approval for particular and normal registration process; both Russian and foreign manufacturers included).

On May 2020 Russian regulators suggested expanding the list of medical devices appropriate for accelerated pathways.

  1. Restrictions on the procurement of medical furniture, certain protheses and orthopedic devices

On 30 April 2020 the Russian government published Resolution #617, ‘On restrictions on the admission of certain types of industrial goods originating from foreign states for the purpose of procurement to meet state and municipal needs’ (link in Russian). The document introduced a list of goods originating from foreign countries including medical furniture, protheses and certain orthopedic devices which are subject to restrictions for state and municipal procurement. Products in the list are subject to the ‘third odd one out’ rule which states that the public procurement process must exclude foreign manufacturers if at least two bids from local (Eurasian) manufacturers are submitted for tender.

It should be noted that the list of industrial goods introduced by Resolution #617 , a similar list of medical devices was introduced in Russia in 2015 under Resolution #102 (link for current version of the in Russian).

3. Updated risk indicators for control on medical devices

On 8 May 2020 the Russian Ministry of Health published a draft document, ‘On the approval of risk indicators <…> in the field of circulation of medical devices to be used as the basis for unscheduled inspections …’ (link in Russian).
The document sets out four indicators that may be used reasons for the regulator to initiate an unscheduled inspection/audit of medical device manufacturers and their representatives/distributors.

Suggested indicators include:

  • Discrepancies in information about medical devices published in the media with information submitted for registration.
  • Information revealed concerning a potential threat to human life or public health for a medical device registered in Russia that has been published by international regulatory agencies but not reported to the Russian competent authority.
  • Two or more warning notices regarding violation of the medical device regulations have not been replied by the manufacturer.
  • Information on a violation during pre-registration testing or clinical trials obtained by the regulator from monitoring the media.

To be recalled that risk indicators were introduced in November 2019 under the Russian medical device regulation, Resolution #1433 (link in Russian) and a previous version of the indicator list was published in January 2020.

According to Resolution #970 on the state control of medical devices, the Russian healthcare regulator Roszdravnadzor performs regular planned and unplanned inspections of medical device manufacturers and their representatives.

Russia Introduced Temporary Simplified Batch Approval Process for Medical Devices for Emergency Use

On 6 April 2020, the Russian government released the Resolution #430 (link in Russian) with a list of 108 medical devices and IVD products intended for emergency use for prevention and treatment of coronavirus infection (including lung ventilators, oxygenators, SARS immunological and molecular assays,  sample extraction kits, artificial blood circulation machines, thermometers, facial masks, gloves and certain protective clothes).

-The Resolution #430 introduced simplified six days batch-by-batch approval process for medical devices and IVD products included in the list until the end of 2020; The new approval process will skip he current requirements for local testing according to 2n Regulation;

– Resolution #430 allows importation of non-registered medical devices and IVD products included in the list for the type testing and clinical trials without additional permits;

– Resolution #430 allows delivery/selling in Russia of non-registered single use medical devices included in the list upon condition of their disposal after 1 January 2021.

Response to COVID-19 in Russian and Eurasian Medical Device Regulations

Dear Colleagues,

This is my monthly update regarding changes to medical device regulations in Russia and the Eurasian Union; this month will be entirely devoted to a review of recent legislation changes related to the coronavirus COVID-19 outbreak:

  • On 26 March 2020, the Russian Ministry of Health announced a green channel regime for approval in Russia for medical devices intended for the diagnosis of coronavirus COVID-19 infection. The published letter on this matter (link in Russian) informs that ‘in condition on rules of submission of documents for registration are respected, medical devices intended for diagnosis of coronavirus infection will be performed in shortest time’. The same document also announced that pre-registration consultations with manufacturers regarding the approval of medical devices that are intended for the diagnosis of coronavirus COVID-19 infection are provided by expert institutions at no cost.
    However, it should be noted that this announcement does not introduce any new approval track/route, but rather expedites the existing testing and registration procedure.The first coronavirus IVD assay was approved in Russia, according to the information from the national medical device register, on 11 February 2020.
    For 30th March 2020, according to the Russian Minister of health, there are seven assays approved in Russia, and review of such applications <by the regulator> is performed “within one-two days”.
  • On 18 March 2020, the Russian government released the Resolution #299 (link in Russian) and simplified the registration route for 36 types of low-class, protective medical devices, including surgical/protective face masks, respirators, medical protective clothes, surgical suits, medical gloves, overshoes, and others.
    According to the published resolution, Roszdravnadzor, the Russian medical device regulator, will make a decision on the approval of such protective devices within five days from the receipt of the registration file; this will be carried out on the condition that a manufacturer provides documents confirming the safety and quality parameters of these devices (testing and trials reports) within five months from the approval from the regulator. In the case where discrepancies (between data submitted for registration and in the test reports) appear, such approval may be withdrawn. The above mentioned resolution was followed by methodical guidelines (link in Russian), clarifying a new, simplified procedure.
  • On 2 March 2020, the Russian government released the resolution #233 (link in Russian) and implemented a temporary ban on the exportation of certain types of medical devices and protective equipment from Russia, including face/surgical masks, respirators, protective glasses, medical protective clothes, and others – 16 types of medical products are included in the restriction list. According to this resolution, the export ban on these devices will be effective until 1 June 2020.
  • On 25 March 2020, the Eurasian Commission published the decision #25 (link in Russian) and annulled the importation customs fees for several medical devices intended for the diagnosis and prevention of COVID-19 infection, which are included in the special list provided in the same document – the list includes IVD assays, protective clothes, and personal protective medical products. The document grants exemption from fees on the importation of products on the list from 16 March until 30 September 2020, in the territory of the Eurasian Union.
  • Since 26 March 2020, the Russian parliament has been discussing the draft federal law (link in Russian), which may grant the Russian government the right to introduce a special procedure for the approval of medical devices, as well as the suspension of the wholesale and retail sale of medical devices in Russia for up to 90 days in the case of an emergency or epidemic.
  • All registration inspections for medical device manufacturers have been cancelled/postponed by the Ministry of Health of Belarus (link of the published letter in Russian), as well as the Kazak competent authority (link to the announcement in Russian).

The first cases of COVID-19 infection were reported in Russia on 31 January 2020, and until today the rate of infection continues to climb. On 30 March 2020, Russia closed its borders and imposed a nine-day national shutdown.