Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, July 2020

 

Dear colleagues,

Let me summarise the most important news and updates from the Russian medical device regulatory landscape in July 2020.

  1. Russia Abolished Certain Excessive Medical Device Regulations 

On 4 July 2020, the Russian government published the Resolution 982 (link in Russian) and, in the framework of the so-called ‘regulatory guillotine’, abolished some of the national medical device regulations. 

The most serious changes affected Russian post-market requirements for medical devices (i.e. the cancellation of Regulation 12N on adverse event reporting and Regulation 175N on safety monitoring) and their exclusion from the list of products requiring a GOST certification. 

The published resolution also abolished the regulation on the licensing of manufacturing and technical maintenance of medical equipment and the rules regarding the destruction of counterfeit medical products.

In addition, it will cancel 11 other minor regulations affecting medical devices, starting in January 2021. 

Later, on 29 July 2020, the Ministry of Health published a new draft of a regulation on medical device safety reporting (link in Russian) intended to replace the cancelled regulation. 

The ‘regulatory guillotine’ initiative was announced by the Russian government in 2018 as a measure to cancel the regulatory acts that are no longer effective for the excessive and inefficient regulation of business.

  1. Updated Medical Device Examination Requirements in Russia and Kazakhstan

On 24 July 2020, the Russian Ministry of Health released an updated version of the regulation on the examination of medical devices for their state registration (link in Russian), which replaced its obsolete version.

The document reflects recent changes in higher-level regulations and describes the examination procedures of medical devices (as a part of the registration process) depending on the class of the device or/and the type of submission (e.g. registration of low-class devices, in-vitro diagnostics; accelerated track for medical devices included in the emergency list; examination processes for registration renewals).
Similar changes have recently been implemented in Kazakhstan. The new version of the examination rules, released on 10 July 2020 (link in Russian), allows registration approvals without quality inspections of the manufacturers or/and type testing at the manufacturing sites as a response to the pandemic.

  1. Eurasian Technical Testing Requirements Updated and theSecond Product Approved

On 10 July 2020, the Eurasian Economic Commission published a draft of a regulation on technical testing requirements for Eurasian registration procedures (link in Russian).

The draft clarifies the testing procedures of medical devices for Eurasian registration and the requirements for the accreditation of testing laboratories.

As it was stated in the previous version of the regulation, the objective of technical trials is to demonstrate conformity to Eurasian essential safety and efficiency requirements and standards. The regulations allow testing one ‘typical model’. In cases of groups of similar products and of capital equipment, technical testing may be performed in the countries where the devices are installed. Technical testing is not required for in-vitro diagnostics.

At the end of July 2020, two medical/in-vitro devices have received Eurasian approval.

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