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 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.


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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