Dear fellow colleagues,
This is a monthly update with a selection of the latest news on medical device regulation changes across Russia and the Eurasian Union for June 2018.
- Russia: Simplification of the Registration of IVD Products and Other Multiple Changes in Medical Device Registration Rules
During the first few days of June 2018, the Russian government released resolution # 633 (link in Russian) and enforced the long-awaited multiple changes in the Russian medical device registration rules.
The enforced changes have a most significant impact on the procedure for the registration of IVD products. Henceforward, all classes of IVDs pass through a one-step assessment process (instead of a two-step assessment process, as previously followed), eliminating several months of the assessment phase in obtaining authorisation for clinical trials. From now on, mandatory local clinical trials for diagnostics may be conducted in parallel with technical assessment before submission to the Russian competent authority, Roszdravnadzor. This may, hopefully, shorten the overall challenging approval process for IVDs in Russia by up to several months.
Another significant change affects the registration of medical devices with a pharmaceutical component. The resolution released replaced the requirement for the mandatory registration of the drug component as a pharmaceutical substance in Russia (which was considered a significant roadblock in the approval of such medical devices in Russia) by a new requirement to provide confirmation of the quality of the drug component according to the regulations in the country of its origin.
The enforced changes will also affect the procedure for registration renewals (amendments of the registration certificates and amendments of documents of the registration dossier), introducing classification of the registration renewals depending on the product/design changes.
Some other minor changes in the registration procedure and timelines overall were aimed at simplifying the IVD and medical device approval process and making registration requirements similar to upcoming Eurasian medical device registration rules.
2. Eurasian Economic Union: Updated Criteria for Borderline Products
On 22 June 2018, the Eurasian commission published an updated version of the draft of recommendations with criteria for interpreting whether or not a borderline product would be considered a medical device within the terms of Eurasian medical device regulations (link to the document in Russian).
The document provides guidance for how to classify products as medical devices, in-vitro devices, cosmetic/toiletry products, disinfectants, general purpose products, assistive/rehabilitation products, products for sports or leisure, personal protective equipment, medical software, medical packaging, physiotherapy devices, medical furniture, medicinal products and medical devices with a drug component and some other products depending on their intended use.
These criteria can be used in the preparation of documents for the registration of medical devices and also in the examination of the effectiveness of medical devices in accordance with these rules.
3. Kazakhstan: New List of Medical Products Exempt from VAT
On 15 June 2018, the Ministry of Health of Kazakhstan, according to its resolution #124, enforced the new list of medical products (pharmaceutical products and medical devices) for which the selling and importing are exempt from value added tax (VAT).
The new list is available online (link in Russian).
Thank you for following my blog, which is a non-commercial project with the objective of making Russian and Eurasian medical device regulations clearer for regulatory professionals. You can also follow my updates on Twitter @Meddevrus.