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

Dear colleagues, 

This is my usual selection of the highlights from the medical device regulatory landscape for Russia and the Eurasian Union over the last month

  1. Update on the Requirements for State Procurements for Medical Devices Containing Plastic Materials in Russia

    On 28 January 2021, the Russian government released Resolution #76 (link in Russian), which updated the criteria for the restrictions for public and municipal procurement for single-use medical devices made from poly-vinyl chlorides (PVC). Since 2017, these types of devices have been subject to restrictions (in certain conditions) for government procurements, according to List #2 of the Resolution #102.

    The published document extended the scope of the resolution to medical devices made not only from PVC but also from other plastic materials and introduced the localisation indicator of the production of medical devices included in the list.
    For the end of February 2021, List #2 for the Resolution #102 contains over 100 types of PVC and plastic medical devices, which are classified into six groups.

  2. Update on the National Medical Registration Rules in Kazakhstan

    Kazakhstan constantly updates the local medical device regulations, as follows:

    The updated version of the 735 Regulation (link in Russian) allowed a registration certificate to be obtained for a medical device with an unlimited validity period after the first submission.

    The updated version of the 736 Regulation (link in Russian) simplified the registration procedure for medical devices manufactured in the European Union, United States of America, Canada and Japan, and at the same time, was approved by the regulatory agencies of the aforementioned countries. Henceforward, these devices may skip the laboratory testing stage for the registration expertise.
    The same regulation has also updated the conditions for the accelerated 30-day registration pathway for medical devices for COVID-19 emergency use – henceforward, these procedures may only be applied after preliminary approval by the regulator.

    The Order#  282/20 (link in Russian), which was released in December 2020, updated the requirements for the procedure of the safety and quality assessment for medicinal products and medical devices in Kazakhstan via the declaration procedure.
  1. Renewal of Certain National Standards Related to Medical Devices in Russia:

Over the last few months, several national GOST standards, which are applicable to different types of medical devices in Russia, have been updated as follows:

In January 2021, certain parts of the national standard for electrical requirements for blood circulation monitors and ultrasound equipment and the national standard for needles colour coding were renewed.

From March 2021, the following renewed versions of the standards will come into force:
– General technical requirements for medical devices (GOST 50444-2020);

– Certain parts of the national standard on biocompatibility assessment (GOST ISO/TR 10993);

– New versions of the standard for technical requirements and the assessments for an endoscopy GOST 58936-2020 and MRI equipment GOST 59092-2020.

I would like to thank LIMI Consulting for the continuous support and updates on Kazakhstan that I used in my review.