Monthly Archives: April 2019

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, April 2019

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Dear colleagues,

This is my usual selection of highlights on the changes made to the medical device regulations and trends across Russia and the Eurasian Union over the last month:

 

  1. Some updates on the Eurasian Medical Device Regulations

On 19 April 2019, the Eurasian Commission published Regulation No. 62 ‘On the classification of the areas of intended use for medical devices’ (link in Russian). This third-level regulation document provides a classification system for the intended use of the medical devices that should be used by the applicant in the preparation of documents for the registration dossier.

Earlier, on 3 April 2019, the Eurasian Economic Commission (EEC) published a draft decision ‘On the rules for assessing and authorizing inspecting organizations to conduct QMS inspections.’ (Link in Russian)

According to the official comment in the published document, the EEC does not support the approach proposed earlier, whereby only government bodies can act as inspecting organisations. The proposed draft document contains the requirements and criteria for the QMS inspection organisations, a description of its accreditation procedure (45 days), as well as the subsequent scheduled and unscheduled government audits (at least once over a two-year period).

It should be recalled that on 16 March 2019, it was the end of the transition period which provided manufacturers with a delay in conducting QMS inspections for Eurasian registration.

 

 

  1. The Russian regulator announced a decrease in the number of registration refusals in 2018

On 26 April 2019, the Russian healthcare regulator, Roszdravnadzor, published a video with its annual report for the year 2018. It cites a 38% decrease in the number of registration rejections during last year when compared to the year 2017: 1342 new medical devices were approved and 398 registration applications were rejected in 2018.

rzn-registrations-2018.png

 

Screenshot from the Roszdravnadzor  annual report 2018 shows 38% decrease in number of medical device registration refusals compared to previous year : http://www.roszdravnadzor.ru/news/16631

 

In addition, the regulator announced its priorities for regulations concerning medical devices in 2019 as being: an introduction of the unified database of patients with implanted medical devices; the development of labelling approaches for medical devices; and the organisation and carrying out of activities to inspect the manufacturers of medical devices according to the Eurasian regulation model.

 

  1. Kazakhstan has amended the requirements for inspections

On 10 April 2019, the government of Kazakhstan published the order No. ДР DSM-26 ‘On Approval of the Rules for Inspection in the Sphere of Circulation of Medicinal Products, and Medical Equipment’ (Link in Russian). The document updates the previously established rules and requirements for conducting inspections of manufacturers of pharmaceutical products and medical devices in accordance with Kazakh legislation.

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Three Things You Should Know about Medical Device Regulations in Russia, March 2019:

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Dear fellow colleagues,

 

This is my usual newsletter with a selection of updates regarding the medical device regulation landscape in Russia and the Eurasian Union for the last month.

 

  1. International Medical Device Regulators Forum in Moscow

    IMDRF.jpg

The 15th International Medical Device Regulators Forum (IMDRF) and Open Stakeholders Forum were held from 19–21 March 2019 in Moscow. Here are some of the most important outcomes from the event:

The Russian healthcare regulator Roszdravnadzor reported about preparation at the conclusion of the Forum with regard to final versions of the following documents, which are “in process of implementation as part of the Russian regulation system”:

  • ‘Principles of labelling of medical devices, including medical devices for in vitro diagnostics’;
  • ‘Guidelines for the application of the system of unique identification of medical devices UDI’;
  • ‘Terminology of adverse events: terms, structure, codes; Appendix E, F’;
  • ‘Electronic registration for medical devices (IVD & non IVD)’;

On 20 March 2019 the IMDRF issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents explaining how to build submissions using its table of contents structure.

Moreover, ahead of the Forum on 18th March 2019 the Global Medical Device Nomenclature (GMDN) Agency signed a Memorandum of Cooperation with the Eurasian Economic Commission to enable it to use the GMDN to support the improved identification and regulation within the Eurasian medical device regulatory system.

The next meeting of the IMDRF Leadership Committee is planned for 16–19 September 2019 in Yekaterinburg.

 

  1. Russia is Discussing a Potential New Regulatory Path for the Scientific Application of IVDs

On 27 February 2019, the Russian Ministry of Health published a draft federal law (link in Russian) suggesting a potential new regulatory path for some in vitro diagnostics (IVDs) in Russia.

Thus, according to the document, IVDs that are developed, manufactured and applied in the laboratories or medical organisations engaged in scientific activity, may be allowed for use without registration upon condition that special five-year permits are obtained by the said medical/scientific organisation and the IVD product is included in the special register after the assessment procedure (expertise).

The draft document also describes control measures and algorithms of safety monitoring for such IVDs and the requirements for the medical/scientific laboratories that apply such products.

It should be noted that the registration procedure for all IVDs in Russia was simplified in June 2018; however, even today it still remains quite a long and complex process.

 

  1. New Version of the List of Medical Devices with Reduced VAT

On 15 March 2019, the Russian Ministry of Health published a revised version of the draft amendments to the list of medical devices exempted from VAT (link in Russian).

It should be recalled, that a single list of medical devices with a reduced VAT rate was approved by the Russian government in the Resolution 1042 in September 2015; however, since January 2017, after the entry into force of the new Russian classification system some of the medical devices (for example, some cardiac pacemakers, computer tomography, electrocardiography, and pieces of ultrasound and laser equipment) on the list were changed into categories that in practice do not have tax preferences. The published draft with a new version of the list based on a new classification system contains new codes and is intended to remedy this situation.