Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, June 2018

 

Dear fellow colleagues,

This is a monthly update with a selection of the latest news on medical device regulation changes across Russia and the Eurasian Union for June 2018.

  1.       Russia: Simplification of the Registration of IVD Products and Other Multiple Changes in Medical Device Registration Rules

During the first few days of June 2018, the Russian government released resolution # 633 (link in Russian) and enforced the long-awaited multiple changes in the Russian medical device registration rules.

The enforced changes have a most significant impact on the procedure for the registration of IVD products. Henceforward, all classes of IVDs pass through a one-step assessment process (instead of a two-step assessment process, as previously followed), eliminating several months of the assessment phase in obtaining authorisation for clinical trials. From now on, mandatory local clinical trials for diagnostics may be conducted in parallel with technical assessment before submission to the Russian competent authority, Roszdravnadzor. This may, hopefully, shorten the overall challenging approval process for IVDs in Russia by up to several months.

Another significant change affects the registration of medical devices with a pharmaceutical component. The resolution released replaced the requirement for the mandatory registration of the drug component as a pharmaceutical substance in Russia (which was considered a significant roadblock in the approval of such medical devices in Russia) by a new requirement to provide confirmation of the quality of the drug component according to the regulations in the country of its origin.

The enforced changes will also affect the procedure for registration renewals (amendments of the registration certificates and amendments of documents of the registration dossier), introducing classification of the registration renewals depending on the product/design changes.

Some other minor changes in the registration procedure and timelines overall were aimed at simplifying the IVD and medical device  approval process and making registration requirements similar to upcoming Eurasian medical device registration rules.

2.       Eurasian Economic Union: Updated Criteria for Borderline Products

On 22 June 2018, the Eurasian commission published an updated version of the draft of recommendations with criteria for interpreting whether or not a borderline product would be considered a medical device within the terms of Eurasian medical device regulations (link to the document in Russian).

The document provides guidance for how to classify products as medical devices, in-vitro devices, cosmetic/toiletry products, disinfectants, general purpose products, assistive/rehabilitation products, products for sports or leisure, personal protective equipment, medical software, medical packaging, physiotherapy devices, medical furniture, medicinal products and medical devices with a drug component and some other products depending on their intended use.
These criteria can be used in the preparation of documents for the registration of medical devices and also in the examination of the effectiveness of medical devices in accordance with these rules.

3. Kazakhstan: New List of Medical Products Exempt from VAT

On 15 June 2018, the Ministry of Health of Kazakhstan, according to its resolution #124, enforced the new list of medical products (pharmaceutical products and medical devices) for which the selling and importing are exempt from value added tax (VAT).
The new list is available online (link in Russian).

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Thank you for following my blog, which is a non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer for regulatory professionals. You can also follow my updates on Twitter @Meddevrus.

Russia Released Multiple Changes in Medical Device and IVD Registration Requirements

It’s a quite a good news for IVD manufacturers… In the first days of June 2018, the Russian Government released the resolution #633 (link in Russian) and approved significant multiple changes in the procedure of registration of medical devices in Russia:

  • Simplification of the registration process of in-vitro diagnostics (IVD) proposing one-step expert assessment (expertise) for registration instead of the current two-step pathway. All classes IVDs pass henceforward through simplified registration process by analogy with class I and non-sterile class IIa medical devices;
  • Significant changes for the list of reasons, requirements and timelines for regulatory renewals (amendments of the registration certificates and amendments of documents of the registration dossier) for already registered devices; the list of cases when expert assessment (expertise) is not required for re-registration was clarified;
  • Update of requirements for documents of registration file for IVDs and medical devices with pharmaceutical component;
  • Extension of the list of reason for registration rejection and cases when registration certificate may be withdrawn/annulled;
  • Other minor amendments on registration procedure e.g. requirement of providing information of trademark, clarification of number of possible additional document requests from the assessment body and clarification of administrative requirements for the applicant…

Overall,  the amendments of the resolution #633 harmonise Russian medical device registration requirements with Eurasian regulations and aimed to simplify IVD and MD approval process.

Three Things You Should Know about Medical Device Regulations in Russia, May 2018

Dear Colleagues, 

Here is my usual monthly selection of highlights about what happened in the Russian medical device regulations landscape in May 2018:

  1. Simplification Requirements for Substance-based Medical Devices (draft)On 30 May 2018, the Russian Ministry of Health published a draft regulation suggesting the simplification of requirements for registration and pre-registration testing of substance-based medical devices in Russia.
    According to regulation #11N, enforced in March 2017, one of the requirements for registration of medical devices with ancillary pharmaceutical substances is mandatory registration of the pharmaceutical component of the product in the Russian register of medicinal products prior to registration of the device. This became one of the most pressing regulatory problems in Russia and increased the number of registration rejections in 2017.
    The amendments proposed in the published draft suggest replacing the requirement above with submitting ‘…documents on quality of pharmaceutical substance <…> taking into account the intended use of a medical device <…> and issued according to the regulation of the country of origin of this pharmaceutical component’. The published draft is now passing through the procedure of public discussions by the end of June 2018.
  1. Mandatory Multi-Central Clinical Trials for IIB and III class devices (draft) 

    Another suggestion of the published draft regulation is the expansion of the list of cases when clinical trials involving human subjects are required for medical device approval in Russia.
    Currently, according to resolution 2N, registration of most medical devices in Russia is mainly based on evaluation of clinical data, and clinical trials involving human subjects must be conducted in accredited clinics after the approval of the ethics council in a limited number of cases: for new types of medical device; for new complex or unique or special methods of prevention, diagnosis or treatment; and in cases where the effectiveness or safety of the medical device are not confirmed in the evaluation of clinical data.
    The published draft document tightens these rules and introduces a requirement for all medical devices of IIB and III classes to undergo mandatory clinical trials involving human subjects, to be conducted in at least two medical organisations under a single clinical trials protocol.
    The same draft document also suggests the innovative new possibility of conducting on-site clinical trials in limited cases.
    It should be also noted that the amendments suggested in the draft document would make Russian and Eurasian clinical trial requirements more similar. Proposed amendments are now passing through the procedure of public discussions by the end of June 2018.

  2. Clarification on application of a reduced tax rate for medical devices in RussiaAt the end of May 2018, the Ministry of Finance of Russia published a letter On the application of the VAT rate of 10 per cent for imported and sold medical products in Russia (link in Russian). In this letter, the regulator clarifies that the list of medical devices taxed at a rate of 10% is approved by Decree of the Government of the Russian Federation N 688 (link in Russian to the latest version, updated on January 23, 2018). This should be guided by the codes of medical products, determined in accordance with the nomenclature of Eurasian customs commodity code EAEU TNVED and Russian product classification code OKPD 2.

Three Things You Should Know about Medical Device Regulations, April 2018

Dear Colleagues,

This is an update for April with a selection of the latest news on medical device regulation changes across Russia and the Eurasian Union countries.

  1. Statistics on Medical Devices in Russia in 2017

At the beginning of April 2018, Russian medical device regulator Roszdravnadzor announced statistics and published a detailed report on approvals of medical devices and post-market control for 2017. It detailed about 1403 new medical devices approved in the last year. It should be noted that, compared to previous years, this amount showed a decrease for the first time since 2014.
The published report (link in Russian) also mentions a significant increase of registration rejections in the last year (647 rejections in 2017 against 477 in 2016), caused, according to the regula

tor, by “among other factors, enforcement of Order 11N on requirements on technical file and instruction for use for registration” in March 2017.

Roszdravnadzor also reports positive decisions to amend 3548 registration certificates and 570 registration dossiers in 2017. The total number of files submitted to the agency by medical

device companies was reported as 5262.
Regarding post-market control, the regulator reports about 5124 inspections and 827 examinations (expertises) of medical devices approved on the market which in 89.5 % cases revealed non-conformities of the examined medical devices with current Russian regulations.89,5.png

  1. Price Regulations for State Procurements of Medical Devices in Kazakhstan

At the end of March 2018, the Ministry of Health of Kazakhstan enforced Order #112 (link in Russian) and updated requirements on the registration of prices for medicines and medical devices for state procurements within the guaranteed free medical care. According to the document, medicines and medical devices may be purchased at prices not exceeding those established by the competent authority. The requirement is applicable for purchases by government institutions within the guaranteed free medical care or using health insurance funds.
Updated rules and guidelines for price and mark-up registrations have been published previously (link in Russian). Prices may be submitted online and should be registered by the competent authority within ten working days. The deadline for submission of information on prices was set as 27 April 2018 by the competent Kazakhstan authority (National Centre of Expertise).

  1. Several Eurasian Medical Device Regulations Approved

There was no breakthrough in start of functioning of Eurasian medical device regulations model in April 2018 compared to previous month; however, the Eurasian Commission approved several “third-level” regulations which come into force in May 2018:

-Regulation #46 on nomenclature of medical devices in EAEU (link in Russian);
-Regulation #47 on classification on adverse events for medical devices (link in Russian);
-Regulation #48 on classification of documents of the registration dossier (link in Russian).

In addition, one other interesting and detailed document published in April 2018 is the draft of the updated guidelines/recommendations for the expertise of medical devices for registration according to Eurasian requirements (link in Russian); however, as of the end of April 2018 the final approved version of the document is not available.

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Three Things You Should Know About Medical Device Regulations in Russia and CIS, March 2018

 


Dear colleagues,

Welcome to my monthly newsletter with updates on medical devices legislation in Russia and the Eurasian Union for March 2018.

  1. Eurasian Quality Management System Requirements for Medical Device Manufacturers

On 15 March 2018, Regulation #106 of the Eurasian Commission on the requirements on the quality management system (QMS) for manufacturers of medical devices for the Eurasian Economic Union (EAEU) registration procedure (link in Russian) came into effect.

The published regulation describes requirements to the QMS for medical device manufacturers and requires mandatory scheduled and unscheduled audits of manufacturing sites to demonstrate compliance with these requirements within the EAEU registration process.

The Eurasian Commission notes that, despite the fact that the requirements were developed on the basis of the international standard ISO 13485, the audits will be based on compliance with the requirements of the EAEU QMS regulation but not with requirements of the ISO standard itself.

At the same time, during the transition period until 15 March 2019, the regulation allows the registration in the EAEU of certain classes of products providing certificate ISO 13485 as evidence of an implemented QMS system, but in this case the manufacturers will have to pass an unscheduled inspection of the manufacturing site within two years from the date of registration.

Summary of EAEU medical device regulations for the end of March 2018:

 

  1. Potential Special Registration Route for Certain Medical Devices Manufactured in Russia

In mid-March 2018, the Russian Ministry of Health published a draft (link in Russian) amendment to article 38 of the Federal Law 323 that introduces a special registration route for certain low-risk medical devices manufactured in the Russian Federation.
The amendments will affect medical devices manufactured by Russian manufacturer, intended for use by medical personnel only and included in the list of “high-tech and innovative products”. The published document also establishes special requirements for post-registration safety monitoring for such products. It should be noted that Russian legislation today does not contain the above-mentioned criteria for “high-tech and innovative” products. It is expected that the amendments will come into force on 1 January 2020.

 

  1. New Medical Device Registration Rules in Uzbekistan

On 23 March 2018, the government of Uzbekistan published resolution #213 (link in Russian) with amendments to the registration rules for medicines and medical devices in the country. The resolution establishes the requirements for documents, samples, and fees for registration of medical devices in Uzbekistan and sets timelines for this procedure as 120–150 days. The approval process may also require clinical trials and manufacturing site inspection. The resolution establishes the validity of the registration license for a medical device as five years and contains a list of devices that do not require registration.

Three Things You Should Know about Medical Device Regulations in Russia, February 2018

Dear colleagues,

Welcome to my monthly update!

One may note that February 2018 was a fairly quiet month in the regulatory landscape for medical devices in Russia. However there are several recent minor updates which may be of interest:

  1. Updated List of Medical Products Taxed at 10% VAT

At the end of January 2018, the Russian government updated resolution # 688 with a list of medical products taxed at the reduced rate of value added tax (VAT) of 10% (link of updated resolution in Russian). An updated consolidated version of the list was aligned with the new national classification of products (enforced since January 2017).

In this context it should be recalled that Russian legislation grants VAT preferences (0% or 10% VAT instead of 18% as a ‘general rule’) for importing and selling most types of medical devices. The list of medical devices taxed at 0% was last updated in November 2017.

 

  1. List of Alcohol-Containing Medical Devices

At the end of January 2018, the draft regulation, ‘on formation of the list of alcohol-containing medical products’ (link in Russian), was published. According to the document, medical devices ‘in a liquid form of release containing the pharmaceutical substance of ethyl alcohol’ should be included in the special list by special commission of the Ministry of Health depending on a number of criteria (volume of consumer packaging, cost and functional purpose of a medical device). The commission is expected to revise the list no more than once a year and no later than 31st March. It is also expected that medical products included in the list will not be regulated by the Russian Law on State Regulation of Production and Turnover of Ethyl Alcohol and Alcohol-Containing Products, which was amended in January 2018.

 

  1. Weighted Average Prices for Polyvinylchloride Plastics Consumables

On 1st February 2018, the Russian Ministry of Health of the Russian Federation published a letter (link in Russian) proposing the updated weighted average prices for foreign disposable medical devices made of polyvinyl chloride plastics (PVC).

The weighted average prices are used for calculation of the guaranteed maximum price for state and municipal purchases according to the methodology provided in Order № 759N (link in Russian) by the Ministry of Health and the Ministry of Industry and Trade in October 2017.

A new scheme for the public procurement of consumable medical devices made from PVC was introduced in Russia in August 2017 with significant extension of the previously adopted Resolution No. 102 ‘On Establishing Access Restrictions for Certain Types of Foreign-Made Medical Products to Procurement for State and Municipal Needs’.

 

Thank you for following my updates!
Just to remind you that you may also follow Russian and Eurasian medical device regulatory updates on myTwitter @MedDevRus

Three Things You Should Know about Medical Device Regulations in Russia, January 2018

Dear Fellow Colleagues,

 

Welcome to my monthly newsletter with my selection of highlights in medical device regulations in Russia. Here are the most important updates for January.

 

 

  1. Road map to Development of Competition in Public Health Sector

 

On the 12th January 2018, the Russian Government published resolution #№9-р (link in Russian) with a roadmap to “developing competition in healthcare” for 2018–2019.
The published document contains a list of suggested strategic measures to develop competition in the public market for medicines, medical devices, healthcare services, and biologically active supplements in Russia, in the coming years.

A significant part of this document is devoted to changes in the regulation of medical devices expected in the next two years. Thus, among others, the following measures were suggested:

 

  • Development of the concept of medical devices of the “open” and “closed” types in terms of the possibility of using consumables or reagents from other manufacturers and the duty of the state and municipal customers to purchase medical products of an “open” type.
  • Development of the concept of the interchangeability of medical devices.
  • Introduction of a ban for manufacturers to set restrictions on the possibility of using consumables/reagents from other manufacturers.
  • Inclusion in the technical documentation for medical device information on the period of operation costs of technical maintenance and repair, costs of training medical personnel for the rules of application, and operation of the medical device.

 

The document also mentions a number of measures to improve and develop the regulation on the procedure of state and municipal procurement of medical products. The full text of the road map is available on the website of the Government of the Russian Federation.

 

 

  1. Checklists and Year Plan for Inspections

 

On the 26th January 2018, the Russian medical device regulator, Roszdravnadzor, published the approved forms of checklists (lists of control questions) that are used by the regulator during routine control inspections/audits of medical device manufacturers and other organisations involved in the turnover of medical devices in Russia.

In total, seven checklists have been published for the monitoring at each stage of the medical device lifecycle (control of pre-registration testing, clinical trials, usage and application in clinics, control of medical device manufacturers and its authorised representatives, technical maintenance, transportation, and storage). The checklists clarify whether organisations are complying with the mandatory requirements set by Russian medical device regulations and standards; they could also be a useful tool for audit preparation.

The list of organisations planned for inspection by Roszdravnadzor in 2018 has been published by the regulator in the beginning of January.
 

  1. Amendments to Regulation of Medical Products Containing Alcohol

 

On the 1st January 2018, article #14 of the Russian federal law #171 (link in Russian), the “regulation of turnover of ethyl alcohol, alcoholic, and alcohol-containing products” came into force. According to the updated regulations, Russian companies carrying out the production, manufacturing, and/or turnover of medical products containing alcohol exceeding 200 decilitres per year are obliged to register and declare this volume of alcohol-containing medical devices in accordance with the established procedure. The regulation defines an alcohol-containing medical device as “medical products in a liquid form of release containing a pharmaceutical substance of ethyl alcohol.”
Another amendment to this federal law was enforced in late December 2017 and establishes that until the 1st July 2018, non-declaring of this information by a company is not considered a violation.

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 Thank you for following this blog!
This is my non-commercial project whose objective is to make Russian and Eurasian medical device regulations clearer.
You can also receive updates directly to your e-mail via the “Follow” button on the toolbar.