Three Things You Should Know about Medical Device Regulations in Russia and CIS – September 2015

Dear colleagues,

This is my monthly update on what is happening in terms of medical device regulations in Russia, the Eurasian customs union, and CIS. As you probably remember, there are only three months left before the new, harmonised Eurasian regulations come into force in January 2016. Meanwhile, September was a rather quiet month in terms of surprises for Russia. Here are my highlights for the region:

  1. Will New Russian Law on Personal Data Affect the Medical Device Sector?

Let me start with highly debated and strategic legal initiative. On 1 September, Russia implemented amendments to Federal Law #152 (link in Russian) “on the processing of personal data in information and telecommunication networks”. The amendments require companies to store personal data about Russian citizens on Russian territory. The law broadly defines personal data as “any information relating directly or indirectly to an identified or identifiable natural person (the subject of the personal data)”. The provisions of the new law are not only strict, but the number of issues remain unclear – particularly for the medical device industry. How will this regulation affect medical device data systems, medical image storage devices, medical communications devices, or any other medical software (or hardware) that transfers, stores, and converts medical patient data, and medical records? How will this law be implemented in terms of data processing for clinical trials of medicines and medical devices? Could this regulation be left unimplemented in terms of medical devices? As you see, there are a number of unanswered questions and nuances that need to be clarified in the coming months.

  1. Changes in the Registration Procedure for Kazakhstan

The Ministry of Health of Kazakhstan has enforced changes to the procedure of registration of medical devices. The new rules have been approved and published in decree #524 (link in Russian). The Kazak approval agency highlighted that the main changes to the procedure relate to the registration application form, which henceforth should be completed in either the Russian and Kazak language, it should contain a GMDN code (if applicable), and information about the prices of medical devices for further price monitoring. The changes also concern the list of documents required for the registration dossier (e.g. requirements in terms of legalisation and bilingual Russian-Kazak packaging design). The new rules have tightened the timeframes for an applicant to respond to additional inquiries from the approval agency after submission. Henceforth, if an applicant does not provide a response within thirty days, the registration could be formally rejected. It should be noted that the medical device registration procedure in Kazakhstan takes from 90 to 160 business days depending on safety class.

  1. Ukrainian Ministry of Health is Discussing the Prolongation of the Transitional Period for the New Approval process for Registered Medical Devices

In September 2015, the Ukrainian Ministry of Health circulated the DRAFT of the of the decree (link in Ukranian) suggesting the prolongation of the transitional period (until 1 July 2017) for the change to the new conformity assessment approval procedures for medical devices that was already registered in Ukraine before 1 July 2015. Previously this deadline was set as 1 July 2016. The document introduced additional requirements for devices imported in this period to be used within their operational period, but not for longer than five years. Meanwhile, for all non-resident medical device manufacturers, the establishment of an authorised Ukrainian representative remains mandatory for the approval and commercialisation of a medical device. As you will recall, since 1 July 2015 access for medical devices into the Ukrainian market must be subject to a new conformity assessment approval process that requires the acquisition of a special conformity mark.

Thank you for following the newsletter. I am always grateful for your comments and encourage you to ask specific questions in the group.

Alexey Stepanov
Alexey@MedicalDevicesInRussia.com
@MedDevRus

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