Dear Colleagues,
Here is my usual selection of highlights to keep you in the loop regarding updates in Russian and Eurasian medical device regulations for the last month.
- Prolongation of the Simplified Medical Device Approval Process in Russia
On 13 November 2020, the Russian government released Resolution #1826 (Link in Russian) extending the validity of the simplified batch-by-batch approval process for medical devices and IVD products intended for emergency use in the prevention and treatment of coronavirus infection introduced in April 2020, for one year (i.e. until the end of 2021).
The published resolution can also extend the validity of licenses that were issued according to this simplified procedure, for particular batches of the products. However, this extension will require the procedure of the administrative replacement.
As of today, the simplified batch-by-batch approval process is valid for 363 types of medical devices, including some IVD assays and laboratory consumables, artificial ventilation machines and breathing circuits, connectors and valves for mechanical ventilation, pulse oximeters, patient monitors, medical furniture, protective masks and other medical devices and protective equipment. There are 278 registration certificates that were issued through this process.
2. Updated Procedure for Safety Monitoring of Medical Devices in Russia
On 2 November 2020, the Russian Ministry of Health published the Order #980n on the approval of the procedure of the safety monitoring for medical devices (link in Russian).
The regulation, that replaced the previous obsolete order cancelled in July 2020, comes into force on 1 January 2021 and will be applicable for medical devices approved according to Russian local procedure until 1 January 2027.
The Russian medical device regulation, requires licence holders to perform safety monitoring by collecting information ‘on adverse effects not specified in the operating manual of the medical device, adverse reactions during its use, the peculiarities of the interaction of medical devices with each other, facts and circumstances that pose a threat to the life and health of citizens and medical workers during their use and operation.’
According to the document, the Russian medical device regulator may receive the information on adverse events from the reporting of manufacturers of medical devices, as well as by monitoring the post-market surveillance databases of regulatory agencies of other jurisdictions or control measures performed by the regulator.
Based on the information received during safety monitoring, the regulator may initiate additional control measures or request a plan of corrective action from the manufacturer.
3. Eurasian Criteria for Classifying Products as Medical Devices
On 24 November 2020, the Eurasian Commission published draft regulations on amendments to the criteria for classifying products as medical devices within the Eurasian Economic Union. (link to the draft document in Russian)
The document proposes changes to existing criteria, issued in 2018 in Regulation #25, in order to eliminate differences in the requirements for classifying products as medical devices between the Eurasian regulations and local regulations of the member states.
Most of proposed changes relate to standardising criteria for medical software with recently updated Russian requirements and some protective equipment.
The draft document is open for public discussion until 25 January 2021.
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Medical Device Regulations in Russia and Eurasian Union 