Tag Archives: post-market

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union – February 2022

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  1. Mandatory notification on all imported medical devices since March 1st, 2022

 March 1st, 2022, is the date of enforcement of regulation #11020 (link in Russian) establishing mandatory requirements to notify authorities for every unit of any medical device imported into Russia, as well as manufactured within the country.

According to the regulation, this notification has to be performed for the purpose of safety monitoring by the regulatory agencies. It should be done by the manufacturer, its authorised representative or the importer of a medical device. Information regarding 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 within fifteen days of importation or manufacturing release of a product.

2. New guidance on quality management system requirements for the registration of medical devices

On February 9th, 2022, the Russian government released regulation #135 (link in Russian) and established rules for the inspection of quality management systems for medical device manufacturers. The document introduces mandatory requirements to submit QMS inspection reports using national procedures for any amendment to registration certificates from June 1st, 2023, and provides detailed guidance on the organisation of the QMS audit.

In addition, on February 18th, 2022, the Russian Ministry of Health released regulation #91N (link in Russian) on methods for determining the amount of payment for the provision of services related to the inspection of the production of medical devices. The document provides tools to calculate required human resources and costs for the inspection of quality management systems for the registration of medical devices.

According to the document, the maximum cost for an inspection is limited to 1.274 million rubles including VAT for Russian manufacturers (approximately 13,000 USD) and 2.729 million rubles for foreign manufacturers (approximately 28,000 USD).

3. New guidelines for pre-clinical and clinical testing for medical devices in Russia


March 1st, 2022, is also a date of enforcement of regulation # 885N (link in Russian) with a new revision of the guidelines for technical assessments, toxicology testing and clinical trials as part of the national registration procedure of medical devices. The regulation will replace regulation #2N (link in Russian) that was effective since 2014.
It should be recalled that the possibility of reopening submissions according to national registration rules for another year has been debated since the end of December 2021. However, as of the end of February 2022, this remained impossible.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, January 2022

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  1. Submissions according to the local medical device regulations of the Eurasian member states are closed, but may reopen

According to the Eurasian agreement on the common principles and rules of circulation of medical devices, 1 January 2022 is the end of the transition period for device registration to move from national to the Eurasian level. 

On 30 December 2021, the Eurasian Economic Commission (EEC) released this protocol (link in Russian) confirming the transition and that all registration dossiers submitted before 31 December 2021 must be reviewed using the original rules. The protocol also confirmed that all medical devices approved locally in Eurasian states before 31 December 2021 could keep their status in the member state until their registration expires. The registrations could also be amended to comply with national rules, which are valid until 31 December 2026.

In January 2022, the Russian medical device regulator Roszdravnadzor announced the closure of submissions for new device registration files complying with the original national regulations. Medical device regulators also published same information in Kazakhstan and Belarus. 

However, on 24 December 2021, the EEC discussed new changes to the agreement, a potential reopening of submissions, and prolonging the transition period for another year. On 19 January 2022, the EEC published Decree 27 (link in Russian) approving this extension which all Eurasian member states should authorize.

In addition, at the end of December 2021, two amendments to existing Eurasian medical device regulations were released by the EEC: Regulation 144, a revision of EEU rules for device registration and examination (link in Russian), and regulation 146, a new edition of the guidance on clinical trials (link in Russian).

At the end of January 2022 there  still  7 medical device approved on the Eurasian database according to new requirements, while the Russian Regulator was saying about hundreds of new submissions per day according to the national requirements for the end of 2021 and more than 31 thousand medical devices approved  on “old approach”.

  1. Upcoming Deadline for submission of clinical monitoring reports in Russia

According to regulation 1113 (link in Russian) that came into force in January 2021, clinical post-market monitoring is now required for class III medical devices and IIB implantable devices registered in Russia afterJanuary 2021. The regulation also states that devices should be continuously monitored, with annual monitoring reports for three years after the approval date. Guidelines for the structure and content of the reports are provided in annex 5 of the regulation.

The deadline for submission of the first reports is 1 February 2022. 

On 21 January 2021, Roszdrvnadzor published a reminder for medical device manufacturers (link in Russian) and clarified the report submission requirements on paper.

3. Extension of the accelerated approval route for medical products for diagnosing and treating COVID-19

In December 2021, the Russian Government released regulation 2250 (link in Russian) and extended until 1 January 2025 the accelerated approval process for COVID-19 diagnostic and treatment products.

According to regulation 430 (link in Russian), more than 400 such medical devices may be approved via the expedited evaluation route with a limited expiration date for a particular batch.

More than 500 existing registration certificates in the national database issued via this route had their validity extended from 1 January 2022 until 1 January 2025;

In January 2022, the Russian regulator confirmed it is possible to submit these registration files using Russian national (but not Eurasian ) criteria. 

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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 recent article on the Eurasian medical device regulation model, which will be published in the Journal of Medical Device Regulation in February 2022.

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

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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 July 2021

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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.

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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 Regulation in Russia and the Eurasian Union, January 2021

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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.


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

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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.