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. 

***

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.

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

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

Dear Colleagues,

Welcome to my monthly review of updates on the medical device regulations landscape in Russia and the Eurasian Union for November 2018:

 

  1. First Registration Files for Eurasian Medical Device Registration Procedures and other Eurasian Medical Device Regulations Updates

“The first applications for registration under the Eurasian Economic Union (EAU) medical device system have been filed for review by competent authorities of Kazakhstan and Russia.” It was announced by the Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission (EEC) in Moscow at a conference organized on 15 November 2018 in Moscow by the medical device manufacturers association IMEDA together with the European Association MedTech Europe and EEC. During the same event it was announced that the unified information system for registration of medical devices  will be launched “in full mode” by the end of this year. Unreadiness of this system was, until now, considered as one of the main barriers to starting registration procedures for the harmonized market.

In addition, on 16 November 2018, the EEC published approved versions of several third-level documents:

  • Regulation # 25 – On criteria for classifying products as medical devices in the EAU (link in Russian);
  • Regulation #176 – On the single register of organizations conducting testing/trials of medical devices for registration in the EAU (link in Russian);
  • Regulation #177 – On the single database on safety monitoring of medical devices in the EAU ( link in Russian);

Earlier in November, the EEC published English translations of all second-level Eurasian medical device documents. The link is available on the official EEC website.

 

  1. Clarification on Valued Added Tax (VAT) for Medical Devices

On 2 November 2018, The Russian Ministry of Finance published a clarification letter (link in Russian) on exemption from VAT for the importation and sale of medical devices in the Russian Federation.

According to the letter, medical devices imported and sold in Russia are exempt from VAT if two conditions are met: the first is the presence of a registration certificate for the medical device, and the second is the inclusion of the product in the list of devices, approved by government resolution No. 1042 of 30 September 2015.

 

  1. Update of some Medical Device National Standards in Russia

 It is important and often critical to use the most updated version of the national standards for the preparation of the technical documentation, testing, and assessment of medical devices in Russia. Several GOST standards relevant for registration of medical devices in Russia will be updated within the next two months.

Thus, on 1 January 2019 the new versions of the following national standards will come into force:

  • Sterilization of health care products. Moist heat (Part 3). Guidance on the designation of a medical device to a product family and processing category for steam sterilization (link in Russian);
  • Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 (link in Russian);
  • Medical devices utilizing animal tissues and their derivatives (link in Russian);

On 1 February 2019 the following national standards will also come into force:

  • Medical electrical equipment. Part 2-49. Particular requirements for the basic safety and essential performance of multi-functional patient monitoring equipment (link in Russian)

 

***

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.