Monthly Archives: October 2016

Three Things you should Know about Medical Device Regulations in Russia, October 2016

Posted on by
3

 

 

Dear Fellow Colleagues and Group Members,

Let me deliver my selection of highlights on the status of the regulation of medical devices in Russia in October.

  1. Draft of Multiple Amendments to Russian Medical Device Regulations

In October 2016, the Russian Ministry of Health published several draft documents (link in Russian) that are intended to implement significant changes into current key medical device regulations (i.e., Federal Law 323 and Resolution #1416).  In general, the trend of proposed changes is in line with Eurasian medical device harmonization. The key suggested changes are:

  • extended validity of the “old” forms (issued before 2013) of medical device registration certificates until December 31, 2021;
  • allowance of official consultancy from Russian medical device regulator and expert organizations for applications to register medical devices;
  • simplified procedure of registration expertise of in-vitro diagnostic (IVD) products (single stage examination rather than the current two stage process);
  • implementation of mandatory annual reporting to Russian authorities of information regarding efficiency and safety data for class IIb and III medical devices within three years of registration approval;
  • implementation of mandatory regular reporting to Russian authorities of information on lot/batch numbers of class IIB and III sterile single-use medical devices and class IIB and III IVD products;
  • implementation of “180 day rule” after submission or notification of changes in the registration dossier. Medical devices that are manufactured within 180 days of date of approval of changes in the registration by the Russian regulator can be legally imported and circulated in Russia according “old” registration dossier (before changes are approved) .

Published documents are currently undergoing public and expert evaluation and they are expected to come into force by the end of the year.

 

  1. List of Implantable Medical Devices: New Version

On 22 October 2016, the Russian Government extended the list of medical devices that can be implanted into the human body, subject of state healthcare programmes (link in Russian). Compared to the previous version of the list, 160 new medical devices have been added and some old devices have been removed (devices that were not implantable, as classified according to current nomenclature).

Recall that, in accordance with Russian Federal Law №323-FZ, prices for implantable medical devices that are included in state programs and that are included in the list are subject to the state regulation.
The first version of the list, which included 202 medical devices, was published in 2014.
Guidelines (link in Russian) for determining the maximum wholesale mark-up that could be made to the actual selling price of medical devices implanted into the human body were approved and published in 2015.
In August 2016, the deadlines for implementation of price regulation were postponed for one year.

 

  1. New Fees for Amendments to the Registration Dossier

Another draft regulation regarding state fees for amendments to the registration dossier was published (link in Russian) by the Russian Ministry of Health in October 2016. Currently, amendments to the registration dossier (according to Clause 55 of Russian medical device registration rules) are free for applicants and mandatory when technical or quality characteristics of the approved medical device are changed.  The new document implements the following fees:

– amendments to the registration dossier for a medical device – 3,500 rubles (55 USD)

– procedure of expertise of amendments to the registration dossier 30,000 rubles (460 USD) – 55,000 rubles (850 USD), depending on the safety class of the device.

 

The objective of this blog is to make Russian and Eurasian regulations more clear. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group. You can also follow me on Twitter @MedDevRus.

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, September 2016

Posted on by
Reply

 

Dear colleagues and group members, please find below my selection of highlights in terms of medical device regulations in Russia, for September:

 

  1. State Control over Medical Devices in Russia
    In September, Roszdravnadzor (the Russian medical device approval agency) published a release about the state control over the circulation of medical devices. According to the regulator, 85% of the medical devices [on the Russian market, checked and tested in the context of state control measures] do not meet the required quality and safety requirements. Recall that today’s Russian medical device regulations require a full correspondence of all characteristics (technical specifications, model and size ranges, labelling, software versions), with the data provided in the registration dossier, and in the case of discrepancies with which this data medical product can be considered as unregistered by the regulator.
    State control over the circulation of medical devices has been implemented in Russia since 2013 and includes the possibility of revisions / audits of medical device manufacturers, distributors and clinics by Roszdravnadzor (see full regulation in Russian). Since 2015, Russia has strengthened the responsibility for violations of medical device regulations and today we can see some of the first legal practices on this.

 

  1. Revised Version of Requirements for Technical Files and Instructions of Use for Medical Devices
    The Russian Ministry of Health published a revised version of the draft of requirements for the technical documentation and instruction for the use (IFU) of medical devices. The document clarifies the full list of the information required in the technical file and IFU for medical devices and in-vitro devices. As you probably know by experience and based on the feedback from Roszdravnadzor, discrepancies and lack of consistency or particular information regarding these documents are the most common reasons in registration delays today.
    An interesting innovation for Russia is that the draft regulation allows a shorter version of instructions for the use for medical devices of the I and IIA class (on the condition that such medical devices can be safely used). According to the document, it is also allowed to distribute electronic forms of instructions for use (on the website or on the screen of the medical devices)—in this case, the manufacturer must ensure that the consumer is informed about how to have access to the up to date version and about how to receive their paper version.
    #
  2. Tax Exemption for Foreign Medical Device Components
    A number of amendments to the Russian Tax Code, exempting Russian medical device manufacturers from paying value added tax (VAT) for importing components and raw material for the medical device manufacturer process in Russia, will come into force on the 1st of October 2016. Until that day, Russian medical device manufacturers are required to pay 18% VAT on any imported components for their products, which, in some cases, poses significant restrictions and impacts on the cost of the manufacturing process. New amendments grant VAT exemptions in situations whereas the imported medical device components or the raw materials have no Russian equivalents and in those cases when their intention for manufacturing a medical device is proven. According to experts, the amendments will help to develop the Russian assembly of complex medical equipment, but their implementation in practice may take some time.