Emergo Group published an interesting review about market entry fees for medical devices for emerging markets. Compared to Brazil and China, Russian registration fees remain rather modest, meanwhile it should be noted that Roszdravnadzor`s fees are just a part of Russian registration budget …
Read more on Emergo Blog
Do you consider Roszdravnadzor fees as a significant factor to make a descision to register a medical device in Russia?
I would be grateful for your comments!
In September 2015 the Russian Ministry of Health published its clarification (link in Russian) on the question, if a medical device can be used in clinics after registration expiry date.
Here in a nutshell…
On 8th of September 2015, the Russian medical device regulator (Roszdravnadzor) clarified requirements for submission of clinical data for simplified approval process for Class I medical devices. For the fastest approval of low class devices, Roszdravnadzor previously recommended submitting in the registration dossier “documents confirming clinical efficiency and safety”. Today the agency confirmed that clinical data should mandatory come from the accredited Russian clinical centers listed in the database of Roszdravnadzor. The Russian regulator highlights, that clinical reports should be designed according the procedure regulated by Decree 2N (link in Russian) and for the simplified registration process does not requires prior application for clinical trial authorization.
Russia’s Prime Minister, Dmitri Medvedev, announced a halt to a proposed ban on state-funding of imported medical goods.
Read full article on Voice of America.
Dear colleagues,
I hope you all enjoyed your summer holidays! Allow me to deliver my usual monthly update of the most important regulatory news in the medical device industry for Russia, the Eurasian Economic Union (EEU), and the CIS region:
In August 2015, the Russian Ministry of Industry and Trade (Minpromtorg) proposed the introduction of a new set of restrictions on the state and municipal procurement of imported medical devices. A new legal initiative proposes to considerably expand the list ‘of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in the Russian Federation’ adopted in February 2015 by way of Decree #102 (link in Russian) which has already imposed a ban on applications to tender for state and municipal procurements for foreign manufacturers of 45 types of medical devices, provided there are two or more entries from manufacturers in Russia, Belarus, Armenia, and Kazakhstan.
The draft of the new initiative, which was published (link in Russian) on the 3rd of August 2015, generated active discussions and an unsought avalanche of attention from the Russian medical device industry as well as non-governmental organisations. “Public discussions” concerning the draft will continue until the 1st of October 2015.
State procurement restrictions may affect antiseptics, disinfectants, medical dressings, some orthopaedic and rehabilitation equipment, condoms, artificial heart valves, defibrillators, dental and endodontic instruments, certain types of ultrasound and X-ray equipment, and some other medical devices. In addition to the 45 medical devices affected in February, there are now more than 90 types of medical devices under discussion.
One should recall that the key strategic objective for Minpromtorg is ‘40% of medical devices for state procurements to be manufactured within Russia till 2020’.
The Eurasian Commission published a new series of “second level” guidelines concerning anagreement on common principles and rules of circulation of medical devices in the Eurasian Economic Union (EEU).
In August 2015, drafts of the following documents became available:
The Eurasian Commission is expected to approve these drafts by the end of September 2015. All approved documents on the Eurasian medical device integration initiative can be found on the official website of the Eurasian Commission.
It is expected that the new medical device regulation system will come into effect in Russia, Kazakhstan, and Belarus on the 1st of January 2016. In these countries, the new system will overhaul regulation approaches for all stages of the medical device lifecycle.
On the 8th of August 2015, the Russian Ministry of Health enforced amendments for the decree #157n (link in Russian) ‘On approval of the maximum allowable amount of narcotic drugs, psychotropic substances and their precursors, contained in medical products’. This decree regulates the maximum amount of such substances permitted per 1 mL of pharmaceutical product or medical device. This may be pertinent to some IVD and dental adhesive materials. The updated and finalised list of substances can be found by following the link in Russian.
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The objective of this blog is to clarify Russian and Eurasian medical device regulations. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group Feel free to follow me on twitter @MedDevRus.
As is known, at the beginning of 2015, Russia adopted the Federal Law # 532 (link in Russian) and implemented amendments to the Russian civil and penal codes enacted stiffer criminal penalties of up to 2,000,000 rubles (app. $30,000) and a jail term of up to 12 years (for aggravating circumstances) for the manufacturing, sale or trade of counterfeit and unregistered pharmaceuticals and medical devices. In August 2015 Russian medical device expert organization VNIIMT held a seminar about control of circulation of medical devices and clarified, what medical devices are considered as “unregistered” and may come under jurisdiction of this law.
Here is the slide:
Dear Colleagues,
As it was mentioned previously, 1 July 2015 was the date of enforcement for the new medical device approval procedures in Ukraine. In this post I would like to provide more details for better understanding of new Ukrainian medical device regulation system:
I.Transition Period
Products already registered in Ukraine for 01 July 2015 will be permitted for importation until 1 July 2016 or until the expiration date of the product’s registration (if this date is earlier than 1 July 2016). Registration cannot be renewed or prolonged.
Products already registered in Ukraine for 01 July 2015 will be permitted to be commercialized and used in clinics by the end of shelf-life of exploitation period mentioned in the IFU.
II. New approval process:
Please see the description of new process in the slideshare chart:
III. Useful links:
Technical regulation #753 – Medical devices (link in Russian)
Technical regulation #754 – In vitro diagnostic devices (link in Russian)
Technical regulation #755 – Active implantable medical devices (link in Russian)
Decree #181 dated 27.05.2015 On transition period (link in Ukrainian)
List of notified bodies accredited by Ukrainian MoH
Ukrainian conformity assessment mark
Dear Colleagues,
Welcome to my monthly update of the latest medical device regulatory initiatives and news for Russia, CIS and the Eurasian Economic Union (EEU):
click here for this post in Russian
After the approval of the Agreement on Common Principles and Rules for Circulation of Medical Devices (link in Russian) in the EEU in December 2014, the new rules of registration of medical devices for the future harmonized system can be called the most important and anticipated legal act among “second level” regulations. At the beginning of July 2015 the draft of new registration rules was published on the website of the Eurasian Economic Commission.
Here I would like to shortly recap the main innovations of this draft, as well as its most significant differences compared to existing medical device regulatory systems in Russia, Belarus and Kazakhstan which could expect us since January 2016:
According to the text of the draft, the new rules do not imply a uniform registration throughout the EEU “by default”. At the beginning, the document introduces the concept of “reference state”, a country in which it is assumed the full cycle of medical device registration occurs with the expertise phase and the “acceptance state”, that accepts the results of expertise by the simplified acceptance procedure of 15 business days. According to the draft, a “reference state” and “acceptance state” are selected by the applicant at the beginning of the registration procedure and after registration is fixed on the title of the registration certificate (see Annex 13).
The non-acceptance of the expert opinion of the reference state (see Clause 32) by another state of EEU, according to the draft, could be reason for prohibition of circulation of a medical device in the territory of the individual states of the EEU.
Form the text of the draft it is not clear whether an authorized representative of the manufacturer is required in each country of the EEU, or one across the entire union.
Probably one of the best pieces of news is that according to the draft, at the beginning of 2016, Eurasian regulation changes seem not to be drastic. Clause three of the new rules introduces a transitional period (exact time is not currently specified). According to the project, during this time the registration dossiers can be submitted either in accordance with existing national legislation of the States of EEU or in accordance with the new harmonized registration procedure. Nevertheless it should be noted that in accordance with clause 15 of the agreement on common principles and rules for the treatment of medical devices, current (local) registration certificates of medical devices will be valid until 31 December 2021 at the latest.
The draft of new registration rules introduces new definitions for: component parts, modifications, accessories, and consumable materials for medical devices (as well as some other definitions). Up to now these concepts caused a lot of questions during the registration process in Russia, because they were not fixed in regulations.
In Russia today (unlike Belarus or Kazakhstan) there is two separate procedures: amendment in the registration certificate (according to Clause 37 of the current Russian registration rules) and amendments to the registration dossier (according to Clause 55 of the current Russian registration rules). Based on personal experience, such separation of procedures is not always obvious and sometimes causes a lot of additional questions from the medical device manufacturer. The new rules introduce a single procedure for amendments to the registration dossier. The changes, according to the project, can be carried out with or without the issuance of a new registration certificate. The document provides the reasons and pathways for such amendments (see Section IV of the draft).
According to clause 15 of the new Eurasian rules, “simultaneous submission for registration of several modifications of the medical device belonging to similar types can be grouped in accordance with the medical device nomenclature of the EEU […] the applicant should submit as a single application and a single registration dossier.” It should be recalled that clause two of the previously approved Agreement on Common Principles for the Treatment of Medical Devices requires “harmonization of the nomenclature of medical devices used in the Member States, with the global medical device nomenclature GMDN”. From a practical standpoint, this change may lead to a multiplication of applications for registration (compared to earlier registrations, particularly in Belarus and Kazakhstan). As you probably know, new nomenclature classification of medical devices has recently been adopted and is already working in Russia and Belarus.
In contrast to the current regulatory system, the new rules propose one-step expertise of not more than 60 business days. (In comparison, today in Russia and Belarus, the expertise phase of medical devices registration takes place in two stages, with the official time of 15-30 business days and for Kazakhstan, a three-phase expertise, lasting up to 180 days). It’s no secret that in Russia today, the stage of expertise is the most challenging for the registration. Clause 23 of the new rules describes in detail the main steps of the new expertise of medical devices for the registration. In the case of a lack of necessary information, the new rules allow a one-time request for additional materials from the expert organization, with 60 working days for delivery of these materials for the applicant (today the similar timeframe for Russia is 50 working days, and in Kazakhstan, 30 business days).
Today, the inspection of the manufacturer is the most difficult stage of the registration of medical devices in Belarus and Kazakhstan, and is used by regulators in a rather limited number of cases. The draft of new rules (see Clause 22) significantly expands the indications for inspections to control the manufacturer’s quality management system, suggesting regulator inspection of the registration of all medical devices of high risk and sterile products of class 2a. Total time for the organization and conduct of such an inspection, according to the project, shall not exceed 90 business days.
A new requirement for the medical device system is the approval of the regulator layout packages and instructions for their placement on the official regulator`s website (see Clause 28 and 35). By analogy with current registration rules in Kazakhstan, the new rules allocate a separate step for approval of the labelling of a medical device (see Clause 24): “the expert organization of the reference state within a period not exceeding 30 business days, confirms the correctness of translation of instructions for medical use and external package marking to the national language in accordance with the requirements of the Member States.”
Formal pre-registration consultations are an interesting and long-debated innovation. Clause six of the draft of Eurasian registration rules establishes the possibility of prior consultation from the expert organization “on all issues of expertise and registration.” In its conferences and seminars Russian medical device regulator Roszdravnadzor talked in length about this possibility and the lack of legal mechanisms for its implementation. It should be remembered that today any consultations in the framework of the medical device registration procedure or any contact between an applicant and expert organization are officially prohibited in Russia.
The draft of new Eurasian medical device registration rules introduces the following timeframes for the main steps of medical device registration procedure:
• Five business days for formal checking of the registration dossier
• Three days to initiate registration procedure
• 60 business days for the expertise for registration procedure
• 30 business days for expertise for amendment procedure
• 90 business days for the organization of inspections of manufacturing site
• 30 business days to confirm the accuracy of the translation of instructions and markings
• 15 business days for the procedure of acceptance in selected countries of the EEU
The new rules also set out the following timeframes to provide additional materials on additional regulator`s request:
I would like to remind you that the document published by the Eurasian Economic Commission currently has the status of a draft in the stage of public discussions. New medical device registration rules are expected to come into force across EEU since January 2016.
Disclaimer: Please note that this review is my professional analysis. It is neither an official report, nor official position of any organization or regulatory body.
On 17 July 2015 Russian Ministry of Health will enforce the Decree #303 dated from 3 June 2015 (link in Russian) which implements some quite significant changes in the procedure of expertise of medical devices in Russia for its registration:
Medical Device Regulations in Russia and Eurasian Union 