Dear colleagues,
This is a monthly update with my selection of highlights on medical device regulation changes and trends across Russia and the Eurasian Union.
1. The Eurasian Union: New Third-level Regulations Adopted
On 24 July 2018, the Eurasian Commission adopted and released two new third-level documents entailing Eurasian medical device regulations:
- Regulation #116 (link in Russian) provides definitions, algorithms, and criteria for the registration of the spare parts, elements, modifications, components, and consumable materials of medical devices in the Eurasian Union;
- Regulation #123 (link in Russian) provides criteria for inclusion (grouping) for registration for several modifications to a medical device in one certificate. The suggested criteria (e.g. dimension types, group specifications, or same analytes for in-vitro diagnostics) are applicable on the condition that the modifications to the medical device have the same safety/risk and Eurasian nomenclature classifications.
In addition to the documents released in May 2018 and September 2017, so far, six third-level Eurasian medical device regulations have been adopted overall.
2. Russia: Extension of the Restriction List (Draft)
On 24 July 2018, the Russian Ministry of Industry and Trade published a draft regulation (link in Russian) proposing a further expansion of the list that imposes restrictions on state purchases of medical devices from foreign manufacturers in favour of domestic manufacturers, according to Resolution #102. The published document proposed including six new types of medical devices in the restriction list: medical functional beds, concentrates for haemodialysis, tonometers for intraocular pressure, air sterilizers, dry air thermostats, and otorinoscopes.
Resolution #102 was introduced in February 2015 as a measure to support the “import replacement” programme and to promote the development of the domestic manufacturing of medical devices; since this time, the restriction list has been extended several times, in 2016 and 2017.
3. Russia: Updating Medical Device Inspection Checklists (Draft)
On 6 July 2018, the Russian medical device regulator Roszdavnadzor published a draft document (link in Russian) with amendments to the content of the check-lists used for routine inspections of medical devices manufacturers by the regulatory agency. The published draft document proposed removing from the checklist several questions concerning the use of the Russian language on external labelling and instructions for the use of the medical devices. Amendments to this document are due, given that Decree No. 1037 regulating the language requirements for non-food products in Russia was repealed in March 2018.
However, the removal of the questions about the Russian language from the check-list does not mean the repeal of the requirement for the use of Russian on external labelling and instructions for use for medical devices in Russia, which is currently regulated by other Russian and Eurasian documents.
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Medical Device Regulations in Russia and Eurasian Union 