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

Dear Colleagues,

It is the end of July and welcome to my monthly update, in which I share the latest news and updates on medical device regulations in Russia and countries of the Eurasian Economic Union (EEU).

 

  1. Rules of Medical Device Registration in Eurasian Union have been published.

    On 12 July 2016, the Eurasian Economic Commission published the final and approved version of the Eurasian Medical Device Registration Rules (link in Russian) – one of the most long-awaited regulations of the new EEU Medical Device Harmonized model. As was the case previously, the new registration process for medical devices is based on local pre-clinical testing in an accredited laboratory, clinical trials in one of the member states of the Eurasian Union, and a 60-day expertise phase (assessment) by a governmental expert organization (more details).
    In parallel with these new rules, on 5 July 2016, the Russian Ministry of Health published a draft regulation (link in Russian) aimed at amending the Russian tax code and introducing state fees for registration, expert assessment, amendments and renewals of registration certificates under the new Eurasian Harmonized Medical Device registration procedure.
    By the end of July 2016, eleven of the thirteen final editions of second-level regulations will have been published. Experts at the Eurasian Commission expect the new medical device regulation model to be fully operational by the end of the year.

  2. Russia: Medical Device Trade Associations Warn about Potential Collapse of State Procurement of Implantable Devices.

    On 5 July 2016, the Russian Ministry of Health published  guidelines for determining the maximum amount of wholesale mark-up, to the actual selling price, on medical devices implanted in the human body (link in Russian).
    According to the published document, the maximum size of the wholesale mark-up established by Russian regional authorities takes into account the costs associated with the production of these medical devices. Justification for these production costs must be provided by the medical device manufacturer or its authorized representative. As an example, the calculation of the maximum wholesale mark-up, provided in the published guidelines, is from 1 to 7 per cent or 350 – 10,000 Russian rubles, depending on actual selling price.
    At this same time, leading regional and global medical device trade associations together have called on the Russian Government to postpone implementation of price regulation for implantable devices to January 2018, intensify cooperation between the industry and the regulator, and warn about the potential freezing of state procurement of implantable medical devices in Russia.
  3. Federal Law on “Biomedical Cell Products”
    At the end of June 2016, the Russian Federal Law “On Biomedical Cell Products” #180 FZ (Link in Russian) was signed by the Russian President and officially published. This federal law is a basic document which implements the legal terms of biomedical cell products and regulates their research and development with the related donation of biological material, pre-clinical action, clinical studies, registration, circulation, import and export and transportation of such products. The document will come into force on 1 January 2017.

The objective of this blog is to help regulatory professionals better understand the Russian medical device regulatory system. Please post your comments and questions here or in the Russian medical device regulations LinkedIn group.

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

 

 

Dear colleagues and group members,

Traditionally, summertime is not a very hot season for regulatory updates, so I am glad to share these three important highlights for medical devices in Russia and the Eurasian Economic Union (EEU):

 

  1. Update on Eurasian Medical Device Regulatory Model

On 2 June 2016 the Eurasian Commission published final versions of two second-level pieces of legislation for the harmonized Eurasian medical device regulatory system:

  1. Rules for Biocompatibility Testing of Medical Devices (link in Russian)
  2. List of Medical Devices with Measuring Function (link in Russian)

As at the end of June 2016, ten out of thirteen final versions of the Eurasian medical device regulations have been published. The final versions of two of the most crucial documents – “Eurasian Medical Device Registration Rules” and “Guidance for a Quality Management System for Medical Device Manufacturers” are still under discussion between member states and are expected within the near future.

Recall that although the Agreement on Common Principles and Rules of Circulation of Medical Devices formally came into force at the beginning of 2016, the new system is still not working.

 

  1. Discussions around price registration for medical devices

Some implantable medical devices (i.e. intended for fixation, delivery or extraction of implants or preparation for implantation procedure) may be removed from the “List of Implantable Medical Devices for Medical Aid Provided to Citizens under the Programme of State Guarantees of Free Medical Care” and exempted from the mandatory requirement of price registration. In June the draft law (link in Russian) was prepared and sent to the Russian parliament for discussion and approval.

In this context it should be recalled that 15 July 2016 is the deadline set by the Russian medical device regulator Roszdravnadzor for manufacturers of implantable devices to provide the regulator with information about the prices of their products.

 

  1. Clear identification of the medical device is critical for proper registration

In June, the Russian press loudly reported a story illustrating an example from current Russian medical device regulatory practice. Because of revealed discrepancies in the Russian registration certificate, Roszdravnadzor deemed the medical devices as non-[properly]-registered, and after that banned products of the UK manufacturer and one of the market leaders in its segment (read more in English).

Over the last few years Roszdravnadzor has increased controls on medical devices and requires notifying about any changes in product name or technical parameters of a registered device to ensure consistency between the registration certificate and the previously submitted registration file. Moreover, in contrast to previous registration rules, which allowed common “family” or “umbrella” registrations, clear identification of the brand name and model of the medical device is mandatory for proper medical device registration.

If you like my updates about Russian medical device regulations you can follow me on twitter @MedDevRus or get them directly via e-mail using the “Follow” button on the toolbar of this page.

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

 

Dear fellow colleagues,

Let me deliver my selection of highlights on the status of the regulation of medical devices in Russia and the Eurasian Customs Union in February:

 

  1. Price regulation for implantable medical devices in Russia
    One of the most significant topics is the development of price regulations for implantable medical devices for state programmes of guarantees on gratuitous medical care. Following the publication of Government Resolution #1517 in January 2016, on 10 February 2016, Roszdravnadzor (Russian medical device regulator responsible for price regulation and control) published a list of 412 manufacturers, Russian authorised representatives and distributors to whom it will be sending requests to provide information for the calculation of weighted-average prices regarding the medical devices included in this The regulator recommends submitting this information using a newly createdelectronic database no later than 30 days following the day of receiving the inquiry. In parallel, the Russian Ministry of Health has clarified some categories on the list of implantable medical devices subject to price regulations (see the clause below).

 

  1. Amendments to Russian Public Health Protection Federal Law
    At the start of February 2016, The Russian Ministry of Health suggested a number of amendments to the Russian Federal Law 323 on Public Health Protection in the Russian Federation (link in Russian). Though this law is extremely high level and fundamental healthcare act, some of these amendments are relevant to medical devices:
  • Extension of the number of cases when a medical device needs no registration or is allowed to be imported into Russia unregistered; e.g., medical devices imported for research and scientific needs, forensic medicine, trade exhibitions, as well as for vital requirements for a particular patient (using special permissions).
  • The draft introduces the definition of an implantable medical device, which is in line with similar internqtional GHTF definition
  • The draft clarifies categories of implantable medical devices subject to price regulations.

This legal initiative is not yet adopted and is currently in the development phase; the draft can be traced online via the official Russian regulation web portal.

  1. Status of Eurasian Medical Device Integration
    Eurasian integration – how does it work in practice? Though common Eurasian medical device and pharmaceutical regulations formally came into force in January 2016, for the time being, no information is available from member states pointing to the fact that applicants can take advantage of new registration During the Eurasian session of the seminar held by Roszdravnadzor on 4 February 2016, the speaker from the Eurasian Commission reviewed the status of second and third level regulations, and it was announced that these would take effect in March 2016. Also confirmed was the transition period of five years during which a manufacturer will be able to chose either to submit using “old” national or “new” Eurasian processes; previously, the timeline for the transition period had been interpreted ambiguously.

In this blog, I will keep an updated focus on imitative strategic Eurasian medical device updates, as well as on other regulatory updates, which you can follow using WordPress, Twitter or the LinkedIn group.

Alexey Stepanov
Alexey@medicaldevicesinrussia.com

 

 

Thirty days to provide information on prices for implantable medical devices

Following the publication of the Government Resolution #1517 “On state regulations of prices of medical devices included in the list implantable medical devices approved for state programmes of guarantees on gratuitous medical care in January 2016, Russian authorized representatives of manufactures of implantable medical devices were suggested by Roszdravnadzor, Russian medical device regulator, to provide information for calculation of weighted-average prices of medical devices included in the list. The regulator recommends submitting this information using newly created electronic database not later than 30 days since the day of getting the inquiry.

Related previous posts:

Russia Enforced Price Regulation for Implantable Medical Devices

On 9 January 2016 the Russian government published it`s Resolution #1517 (link in Russian) “On state regulations of prices of medical devices included on the list of implantable medical devices subject to state reimbursement programses”. The resolution set a deadline as 15 July 2016 for manufacturers or Russian authorized representatives to submit to Roszdravnadzor (Russian medical device regulator) files for registration of the “maximum release prices” of medical devices included in the list.

According to the resolution, the maximum release price proposed by a manufacturer for registration may not exceed the “weighted average price” of the corresponding nomenclature type of medical device defined by Roszdravnadzor according to published method (see clause 3). In the same time, further contract price shall not exceed the registered one.

The timelines for price registration procedure was set as 5 business days.

Related previous posts:

Russia Set to Strengthen Price Regulations for Implantable Medical Devices

Russian President Vladimir Putin signed 09.03.2015 an amendments ( link in Russian )  to the article #80 of the Russian Federal Law #323 “On the Fundamentals of Health Protection in the Russian Federation”. These amendments implements additional regulation for implantable medical devices included in the recently approved list for national reimbursement programmes.

 What is now regulated?

  1. Manufacturer`s maximum sale prices for implantable medical devices.
  2. Maximum wholesale markup for implantable medical devices.
  3. Maximum retail markup for implantable medical devices.

 How it will be regulated?

  1. Methodology for detecting prices and markups will be published by the Government.
  2. State registration procedure for prices and markups will be implemented by Roszdravnadzor (Russian medical device regulator).
  3. Public state registry of prices and markups will be implemented Roszdravnadzor.