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

 

Dear Colleagues,

Welcome to my monthly review of medical device regulatory changes in the Eurasian region:

  1. Eurasian Guidance on the Content and Structure of the Eurasian Medical Device Registration Dossier 

On 8 October 2019, the Eurasian Commission published Recommendation #29 ‘On methodical recommendations on the content and structure of documents of the registration dossier for a medical device’(link in Russian). This published document describes the requirements regarding the format, as well as language and legalisation, of documents covering 30 sections of the Eurasian registration dossier of a medical device depending on risk class. Annex II of the document provides guidance on the format of clinical data depending on the safety class of the device and date of clinical trials. Also included is the criteria for acceptance of clinical data from clinical centres outside of the Eurasian Union and requirements for clinical data for an analogue/equivalent device.

It should be noted that requirements for the registration file were previously published and can be found in Annex IV of Regulation #46 (link in Russian), and requirements for the content of technical files is in Annex II and Annex III of Regulation #29 (link in Russian).

  1. New Devices Added to the List of Regulated Implantable Devices in Russia

On 8 October 2019, the Russian government released Resolution #2333-R (link in Russian), which extended the list of medical devices which can be implanted into the human body for providing medical care under the programme of State Guarantees of Free Provision. According to the published document, there are four new types of devices including polymer ligation clips, ligation end loops, implantable dual chamber MRI compatible pacemakers and associated leads.

The prices for medical devices in the list for these programmes are regulated in the manner prescribed by Resolution #1517 released in 2015. 

For today, information about registered prices for these implantables is available on the official website of Russian healthcare regulator Roszdravnadzor 

  1. Kazakhstan Updated Medical Device Classification Guideline. 

On 2 October 2019, the Ministry of Health of Kazakhstan released Order #KR-DCM-129 (Link in Russian) and updated the rules for the classification of medical devices and in-vitro diagnostics in Kazakhstan. This document also contains rules for medical software classification. There are still four classes of medical devices categorised by invasiveness, duration of use, contact with patient, implementation with vital organs, and use of energy sources. Compared to previous revision, the structure of this new version of the Kazak classification is closer to the Eurasian medical classification; however, the two are not totally identical and still contain different classification algorithms. 

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It should also be mentioned that, in October 2019, some minor changes in tax regulations for medical devices have been enforced in Russia and several national GOST standards for plasters, surgical/operating room drapes, dental filling materials and hit implants have been updated and published.

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Your feedback, questions and comments regarding my updates are always welcome🙂

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