Tag Archives: Localization

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

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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, May 2020

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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.

Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union – June 2019

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Dear colleagues,

Welcome to my usual monthly review containing the most important medical device regulation changes across Russia and the Eurasian Union over the past month:

  1. New Restrictions on State Procurements for Certain Medical Devices in Russia

On 26 June 2019, the Russian government published Resolution # №813 (link in Russian) and extended the list “of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in Russian Federation”. 

The state procurement of medical devices included in the list, according to the Resolution #102 introduced in 2015, will be closed to foreign manufacturers if at least two bids on medical devices from local manufacturers (Russia, Kazakhstan or Belarus) were submitted for tender.

Above-mentioned Resolution # №813 has added 14 new types of device to the restriction list including ventilation devices, gamma-therapeutic radiation complex, ultrasound devices, certain types of endoprosthesis, external fixation devices, medical beds, intraocular lenses, intraocular tonometry, micro sources with iodine-125, certain adhesive dressings and surgical materials, medical devices for storage and transporting biological samples, air sterilisers and dry air thermostats.

According to the published document, analogs of each of these products are currently produced in Russia in sufficient volume by at least two local companies. The decision was taken with the aim of supporting the development and production of these products in Russia.

The new revision of the list is available in Russian.

  1. Russian Ministry of Health Clarified Trademark Requirements for Medical Device Registration 

The requirement to provide confirmation of the legitimate use of the Russian trademark for registration of a a medical device is a relatively new requirement, which was introduced by the Resolution 633 in June 2018 and raised a lot of questions and confusion across registration applicants over the last year.

Thus, according to the petition initiated by Russian medical device registration consulting company Medrelis and 28 medical device companies submitted to the Russian Ministry of Health in May 2019, over the past year the interpretation of trademark legitimacy by Russian health care regulator Roszdravnadzor was often controversial and led to additional difficulties in the registration procedure and an increased amount of registration rejections.

On June 2019, the Russian ministry of health, for the first time since the enforcement of the new trademark requirements, clarified (the letter kindly provided by Medrelis) that Roszdravnadzor, to prevent the circulation of counterfeit medical devices, may compare (verify) information provided <for registration of a medical device> by the manufacturer or the authorised representative of the manufacturer (s) with information received, inter alia, as “interdepartmental information interaction” (which means that missing documents confirming trademark legitimacy in the registration file may not be a reason for the registration rejection or additional requests to the applicant from the regulator).

  1. Multiple Updates of Regulations for Medical Devices and Pharmaceuticals in Kazakhstan

Kazakhstan continues to release multiple updates to local medical device and pharmaceutical regulations started earlier this year. Thus, for the past months the following regulations have been released in new revisions: 

  • On 02 May 2019 – the order KR-DCM 53 (Link In Russian) updating the rules of wholesale and retail sales of medicines and medical devices.
  • On 27 May 2019 – Order KR-DCM-88 (Link in Russian) updating pharmacovigilance requirements for pharmaceuticals and rules for safety monitoring of medical devices; 
  • On 7 June 2019 –the Order KR – DCM 82 (Link in Russian) updating requirement rules for assessing the safety and quality of medicines and medical devices registered in Kazakhstan;
  • On 9 June 2019 – the Order KR – DCM 87 (Link in Russian) updating rules of state registration, re-registration and amendments of the registration dossier for pharmaceutical products and medical devices.

New Set of Restrictions on the State and Municipal Procurement for Imported Medical Devices in Russia

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On 7 December 2016 the Russian Government published Resolution #1268 (link in Russian) and extended a list “of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in Russian Federation”. According to the Resolution, sixty two new types of medical devices have been added in the list. For such types of medical products tenders for state procurements will be closed for foreign manufacturers if at least two bids with similar medical devices from local manufacturers (Russia, Kazakhstan, Belarus or Armenia) were submitted. The adoption of Resolution represents a continuation of the course of import substitution taken by the Russian Government in 2014.

Three Things You Should Know about Medical Device Regulations in Russia, August 2015

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Dear  colleagues,

I hope you all enjoyed your summer holidays! Allow me to deliver my usual monthly update of the most important regulatory news in the medical device industry for Russia, the Eurasian Economic Union (EEU), and the CIS region:

 

  1. Possible expansion of restrictions on state procurement for foreign manufacturers of medical devices.

In August 2015, the Russian Ministry of Industry and Trade (Minpromtorg) proposed the introduction of a new set of restrictions on the state and municipal procurement of imported medical devices. A new legal initiative proposes to considerably expand the list ‘of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in the Russian Federation’ adopted in February 2015 by way of Decree #102 (link in Russian) which has already imposed a ban on applications to tender for state and municipal procurements for foreign manufacturers of 45 types of medical devices, provided there are two or more entries from manufacturers in Russia, Belarus, Armenia, and Kazakhstan.
The draft of the new initiative, which was published (link in Russian) on the 3rd of August 2015, generated active discussions and an unsought avalanche of attention from the Russian medical device industry as well as non-governmental organisations. “Public discussions” concerning the draft will continue until the 1st of October 2015.
State procurement restrictions may affect antiseptics, disinfectants, medical dressings, some orthopaedic and rehabilitation equipment, condoms, artificial heart valves, defibrillators, dental and endodontic instruments, certain types of ultrasound and X-ray equipment, and some other medical devices. In addition to the 45 medical devices affected in February, there are now more than 90 types of medical devices under discussion.
One should recall that the key strategic objective for Minpromtorg is ‘40% of medical devices for state procurements to be manufactured within Russia till 2020’.

  1. Harmonised Eurasian regulations for medical devices – four months to go.

The Eurasian Commission published a new series of “second level” guidelines concerning anagreement on common principles and rules of circulation of medical devices in the Eurasian Economic Union (EEU).
In August 2015, drafts of the following documents became available:

  • Common Eurasian rules on safety and vigilance monitoring of medical devices (link in Russian).
  • Eurasian rules for medical devices with measuring function (link in Russian).
  • Common Eurasian nomenclature for medical devices (link in Russian).
  • Guidance for conducting clinical trials for medical devices in EEU (link in Russian).
  • Rules for the common Eurasian informational database for medical devices (link in Russian).
  • Common Eurasian requirements on quality management system for medical device manufacturers (link in Russian).

The Eurasian Commission is expected to approve these drafts by the end of September 2015. All approved documents on the Eurasian medical device integration initiative can be found on the official website of the Eurasian Commission.
It is expected that the new medical device regulation system will come into effect in Russia, Kazakhstan, and Belarus on the 1st of January 2016. In these countries, the new system will overhaul regulation approaches for all stages of the medical device lifecycle.
EEU regulations MD

  1. Update on regulations of narcotic substances for medical products

On the 8th of August 2015, the Russian Ministry of Health enforced amendments for the decree #157n (link in Russian) ‘On approval of the maximum allowable amount of narcotic drugs, psychotropic substances and their precursors, contained in medical products’. This decree regulates the maximum amount of such substances permitted per 1 mL of pharmaceutical product or medical device. This may be pertinent to some IVD and dental adhesive materials. The updated and finalised list of substances can be found by following the link in Russian.

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The objective of this blog is to clarify Russian and Eurasian medical device regulations. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group  Feel free to follow me on twitter @MedDevRus.

Russia Implemented Restrictions for Certain Types of Medical Devices for State and Municipal Procurements.

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The Russian Government published 06 February 2015 the Order # 102 (link in Russian) with a list “of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in Russian Federation”. According to this regulation, the tenders for state procurements will be closed for foreign manufacturers if at least two bids with medical devices from local manufacturers (Russia, Kazakhstan or Belarus) were submitted.

The published order will affect the following groups of medical devices:

  • Medical wear.
  • Some types of PCR reagent kits for detection of inflectional agents.
  • Some types of EIA reagent kits for quantitative and qualitative measurement of immunoglobulins and infection agents.
  • Blood clotting reagents.
  • Antiseptic and sterile drapes and wipes.
  • Some types of reagent kits for hematology analyzers.
  • ABO, Rh, Kell systems reagent kits.
  • Enzyme reagent kits.
  • Nutrient mediums.
  • Substrates reagent kits.
  • Polymer specimen containers.
  • Refrigerators for laboratories.
  • Computer tomogram machines 1-64 slices.
  • Gamma chambers.
  • Some types of X-rays diagnostic complexes.
  • ECG machines.
  • Holter ECG monitors.
  • Glucose analyzers.
  • Pneumatic micro motors for dental hand pieces, air-turbine hand pieces.
  • Surgical needles.
  • Some types of disposable syringes.
  • Microsurgical scissors and pincers.
  • Dental carbide burs.
  • Microsurgical ophthalmic instruments.
  • Some types of blood transfusion devices/ containers.
  • Gynecological tool sets.
  • Implants for ostheosyntesis.
  • Non-implantable hearing aids.
  • Blood plasma electrophoresis devices.
  • Blood coagulation analyzers.
  • Bilirubin analyzers and some types of semi-automatic biochemical analyzers.
  • Individual blood glucose meters.
  • Some types of PCR amplificators.

Three Things You Should Know about Medical Device Regulations in Russia and CIS, November 2014

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At the end of this year, one may see a very slow recovery leading into a positive dynamic for Russian regulators of medical devices: the number of registration approvals is increasing and registration steps are gradually becoming shorter. Active work is continuing for the completion of the upcoming harmonization of regulations between Russia, Belarus and Kazakhstan. Below, please find my monthly selection of regulatory highlights for Russia and the CIS region:

1.”Falling Up”

“Medical Device Market: Falling Up” is the slogan of the strategic session chaired by Russian Ministry of Industry and Trade on the 12th of November as a part of the Medica 2014 exhibition in Dusseldorf. More than 100 industry representatives had a chance to get first-hand information about upcoming changes in medical device regulation in Russia directly from top-level officials as well as to discuss strategic scenarios and investment climate for the industry. The focus of this session was on localization and import regulation programs for medical products in Russia. The key strategic message from the regulator remains unchanged – “40% of medical devices for state procurements to be manufactured within Russia till 2020”.
According to Sergey Tsyb, Deputy Ministry of Industry and Trade, “This proposal has been already submitted to the Government of Russian Federation and we hope that it will be signed off within the month. There is special attachment to this document—the list of medical devices, which are already manufactured in Russia. And if there are two or more Russian analogues, this order will allow Russian manufacturers to compete in supplying their products for the Russian healthcare system”.

2. Advertising of Medical Devices across CIS

On the 20th of November, law #203-5 of Kazakhstan (signed in May 2014) came into force, amending Article 18 of National Health Code on the advertising of medical products. According to these changes, advertising medical products (including medical devices and medical equipment) via mass media henceforward is prohibited; rather, such advertisements can be placed only in specialized medical publications or health facilities. Previously, both medical devices and medicines could be advertised only if authorized by the Kazakhstan Ministry of Health according to special procedures; this has been now cancelled per the amendment above.Moreover, it should be noted that similar changes had been rejected in August 2014 by Russian regulators but are currently under intense discussion in Ukraine.

3. Federal Law on Circulation of Medical Devices…Attempt Number Three

The third version of the draft of Federal Law on the Circulation of Medical Devices became available for public discussion in November. Unlike the previous version of the law, which had been proposed by the Ministry of Health and had received controversial feedback from experts, the new version of the regulation was presented by the Ministry of Industry and Trade of Russian Federation. The text of the law has been considerably expanded, especially in the description of the registration process of medical devices. Apparently, the draft will be submitted to the government for approval within weeks, and the law should be enacted by the end of the year. However, work on it is expected to continue through 2015, as it requires harmonization with upcoming changes in regulations concerning medical devices per the Eurasian Customs Union.

Three Things You Should Know about Medical Device Regulations in Russia, August 2014

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Dear Fellow Colleauges,

At the beginning of my monthly update, I would like to provide some numbers reflecting the activity of the Russian regulator. According to the official Rosdravnadzor site, for the period between 1 and 25 August, 120 registration certificates – both renewals (major part) and new registrations – have been approved, of which 38 approvals for Russian manufacturers. More than 70 unregistered medical devices have been suspended. 102 authorizations for clinical trials and 73 permits for samples importation were issued.

 

  1. New Details on Common Eurasian Medical Device Regulations Emerged:
    Following the fact that the Treaty on the Eurasian Economic Union (EAU) was signed by Russia, Kazakhstan and Belarus on 29 May, the Eurasian Economic Commission (EAEC) published on 11 August the draft of the agreement on common regulations on medical devices for the EAU.
    According to the draft, one registration certificate is anticipated to be valid throughout the whole EAU territory as far as testing performed in one country will be accepted within the Union. The EAEC expects this agreement to come into force on 1 January 2016, and after this date, current (local) registration certificates will be valid until their expiry dates or, if there is no expiry date, until 31 December 2021.
    The draft of the regulations implies a common approach on vigilant data collecting and reporting (a reporting period of five days was set) and labelling (special symbols will be required) for medical devices approved for the EAU.
  2. Coming Regulations on State Procurements of Medical Devices in Russia: “Constraints” Replaced “Strict ban”.
    After the negative feedback from medical and business associations on the draft of the Resolution on “On establishing a ban on individual types of medical devices originating from foreign countries for State and Municipal procurements”, the Russian Ministry of Industry and Trade (Minpromtorg) has officially announced the revision of its position. The term “strict ban” for state procurements for certain groups of medical devices has been replaced with the term “constraints”. The new version of the document assumes that foreign manufacturers will be able to participate in public procurement in the case when fewer than two bids from EAU manufacturers have been submitted for tender. These limitations do not extend to all medical devices, but only to a certain list of products, which has also undergone some changes: some X-ray equipment have been excluded from the list, meanwhile ECG, refrigeration equipment, diagnostic test kits and reagents have been added. It was also highlighted that conformity to the ISO 13485-2011 standard is necessary for EAU manufacturers in order to participate in state and municipal procurements.
  3. New Edition of the Registration Rules in Russia:
    New amendments to the registration rules (Resolution 1416) came into force on 29 July. The most positive outcome is the possibility to eliminate faults during experize phase. Previously there was no such option and any discrepancy in the dossier revealed by the regulator during expertise usually led to an official refusal of registration. On the other hand, some important and broadly-discussed suggestions for improvement, such as fast-track approval for first class medical devices and special procedures to renew expiring registration certificates, have NOT been approved. The new edition of the registration rules slightly extends timelines and reasons for renewals and requires the provision of clinical data in the registration dosser (not before clinical trials as it was previously).