Dear fellow colleagues,
This is my usual newsletter with a selection of updates regarding the medical device regulation landscape in Russia and the Eurasian Union for the last month.
- International Medical Device Regulators Forum in Moscow
The 15th International Medical Device Regulators Forum (IMDRF) and Open Stakeholders Forum were held from 19–21 March 2019 in Moscow. Here are some of the most important outcomes from the event:
The Russian healthcare regulator Roszdravnadzor reported about preparation at the conclusion of the Forum with regard to final versions of the following documents, which are “in process of implementation as part of the Russian regulation system”:
- ‘Principles of labelling of medical devices, including medical devices for in vitro diagnostics’;
- ‘Guidelines for the application of the system of unique identification of medical devices UDI’;
- ‘Terminology of adverse events: terms, structure, codes; Appendix E, F’;
- ‘Electronic registration for medical devices (IVD & non IVD)’;
On 20 March 2019 the IMDRF issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents explaining how to build submissions using its table of contents structure.
Moreover, ahead of the Forum on 18th March 2019 the Global Medical Device Nomenclature (GMDN) Agency signed a Memorandum of Cooperation with the Eurasian Economic Commission to enable it to use the GMDN to support the improved identification and regulation within the Eurasian medical device regulatory system.
The next meeting of the IMDRF Leadership Committee is planned for 16–19 September 2019 in Yekaterinburg.
- Russia is Discussing a Potential New Regulatory Path for the Scientific Application of IVDs
On 27 February 2019, the Russian Ministry of Health published a draft federal law (link in Russian) suggesting a potential new regulatory path for some in vitro diagnostics (IVDs) in Russia.
Thus, according to the document, IVDs that are developed, manufactured and applied in the laboratories or medical organisations engaged in scientific activity, may be allowed for use without registration upon condition that special five-year permits are obtained by the said medical/scientific organisation and the IVD product is included in the special register after the assessment procedure (expertise).
The draft document also describes control measures and algorithms of safety monitoring for such IVDs and the requirements for the medical/scientific laboratories that apply such products.
It should be noted that the registration procedure for all IVDs in Russia was simplified in June 2018; however, even today it still remains quite a long and complex process.
- New Version of the List of Medical Devices with Reduced VAT
On 15 March 2019, the Russian Ministry of Health published a revised version of the draft amendments to the list of medical devices exempted from VAT (link in Russian).
It should be recalled, that a single list of medical devices with a reduced VAT rate was approved by the Russian government in the Resolution 1042 in September 2015; however, since January 2017, after the entry into force of the new Russian classification system some of the medical devices (for example, some cardiac pacemakers, computer tomography, electrocardiography, and pieces of ultrasound and laser equipment) on the list were changed into categories that in practice do not have tax preferences. The published draft with a new version of the list based on a new classification system contains new codes and is intended to remedy this situation.