Tag Archives: Registration

Ten Questions about Clinical Trials of Medical Devices in Russia

Posted on by
Reply

On the 2nd of October 2014 Russian medical device regulator Roszdravnadzor organised a one-day seminar fully devoted to different aspects of clinical trials for registration of medical and in-vitro devices. More than 100 questions on this topic were put to officials by representatives of international medical device manufacturers and local clinics. Below I would like to post ten the most interesting of them answered:

1. Regulations permit two forms of clinical trials: evaluation of clinical data without patient involvement and full-scale clinical trials with patients. Who decides the form in which clinical trials will be required for registration in my particular case? According to regulations, full-scale clinical trials with involvement of patients are required for registration of new types of devices and new treatments or diagnostic methods as well as in cases when safety of medical devices has not been proved with evaluation of clinical data. In the near future Roszdravnadzor expects that all implantable 2b and 3 class medical devices will pass through full-scale clinical trials with patients. Currently, a clinic or trial centre decides if full-scale or reduced trials are required for every particular case.

2. Are clinical trials programmes (plans) and clinical data mandatory in the registration dossier? Yes. Roszdravnadzor confirmed that clinical trials plans and clinical data must be submitted in the first step of the registration (before expertise).

3. Who draws up the plan/programme of clinical trials? Local clinics or trial centres are responsible for composing the plan of the trials together with applicant for registration of the medical device in question. The clinic should be accredited by Roszdravnadzor. ISO 14155 is recommended for trial plans.

4. At what point are clinical trials officially started? Current regulations do not clarify this. The start of clinical trials could be considered as the point of signature of a contract with a clinic or an initial clinical visit or signature of informed consent from the first patient. Applicants must inform Roszdravnadzor about the start of clinical trials for their device within five business days.

5. Is an ethical committee mandatory for clinical trials? Roszdravnadzor confirmed that an ethical committee has worked within the Ministry of Health since July 2014. All clinical trials on patients must be approved by the ethical committee. The procedure of assessment of clinical data should be agreed by the ethical committee only if this data contains personal information of patients.

6. Is the ISO 14155 standard mandatory for clinical trials? National standards are not mandatory in Russia. Meanwhile it should be noted that this standard is considered a minimal requirement. In cases when companies or clinics do not have their own standards or procedures, ISO 14155 is highly recommended

7. What documents are needed to start full-scale clinical trials? Two documents are mandatory for any clinical trial on patients: authorisation from Roszdravnadzor and approval from the ethical committee.

8. Can clinical trials for registration in Russia be performed abroad? Yes. Clinical trials can be performed out of Russia if samples of the device cannot be shipped in the country because of technical reasons (e.g. equipment requires complex installation). In such cases trials must be performed by Russian experts from clinics accredited by Roszdravnadzor during inspection visits. Places where trials have been performed should be noted in the clinical report.

9. How many samples do we need for trials? Samples of medical devices must be provided to the clinic in cases of full-scale clinical trials and clinical data assessment. The quantity of samples required is defined by clinics for every particular case. Samples must be imported according to special procedures with permission issued by regulator.

10. Is it allowed by law to pay patients for participation in clinical trials? Yes, but any payment to a patient must be agreed by the ethical committee of the Ministry of Health.

Three Things You Should Know about Medical Device Regulations in Russia, September 2014

Posted on by
Reply

September saw the introduction of regulatory initiatives which sometimes provoked new questions. Two main aspects of the development of medical device regulations include work on Eurasian medical device guidelines (for which there was no noticeable progress last month) and new legal acts for Russia:

  1. List of implantable medical device reimbursement

Published Order #698, which defines the rules for grouping implantable medical devices in official lists subject to state reimbursement programmes, was the subject of much debate within the Russian medical device industry in September. For future state reimbursement programmes of gratuitous medical treatment system a medical device must be included in this list by a special MoH commission which follows a thirty day procedure. The list should be in line with medical device classification and consist of medical devices registered in Russia based on clinical safety data/justification additionally requested by the commission. The order imposed very strict deadlines for application for inclusion on the current list (as of the 6th of October 2014), but there is not yet a clear list of documents required for submission, the MoH commission still doesn’t exist and the new medical device classifications described in the procedure is far from clear.

  1. New list of medical devices subject to 10% VAT

From the beginning of 2013, new Russian medical device regulations caused confusion over the applicability of VAT for medical device importation. This was largely due to differences in terminology between these guidelines and the Russian tax code. Changes in the Russian tax code in November 2013 made the situation clearer, but the positions of different Russian localities on providing preferential VAT rates for importation remained ambiguous. Government Resolution #870 came into force on the 9th of September 2014, thereby clarifying terminology and confirming the list of medical devices subject to 10% VAT during importation in Russia. Hopefully this will put an end to the lack of clarity for this group of medical products. A government order with a similar list of medical devices subject to 0% VAT is expected within the next few months.

  1. Federal law on circulation of medical devices

The Russian Ministry of Health published a notice about the development of a federal law on circulation of medical devices. The draft of the law is intended to ensure quality, safety and efficacy at every stage of the medical device lifecycle. It is commonly known that this type of unified legal framework is currently missing in Russia, resulting in a number of contradictions between the various regulatory acts in the medical device domain. The MoH announced the target date for this law as January 2016. The text of the current version of the document is currently officially unavailable, and as such it is still unclear how this law will accord with further medical device regulation of Eurasian customs union.

Three Things You Should Know about Medical Device Regulations in Russia, August 2014

Posted on by
Reply

Dear Fellow Colleauges,

At the beginning of my monthly update, I would like to provide some numbers reflecting the activity of the Russian regulator. According to the official Rosdravnadzor site, for the period between 1 and 25 August, 120 registration certificates – both renewals (major part) and new registrations – have been approved, of which 38 approvals for Russian manufacturers. More than 70 unregistered medical devices have been suspended. 102 authorizations for clinical trials and 73 permits for samples importation were issued.

 

  1. New Details on Common Eurasian Medical Device Regulations Emerged:
    Following the fact that the Treaty on the Eurasian Economic Union (EAU) was signed by Russia, Kazakhstan and Belarus on 29 May, the Eurasian Economic Commission (EAEC) published on 11 August the draft of the agreement on common regulations on medical devices for the EAU.
    According to the draft, one registration certificate is anticipated to be valid throughout the whole EAU territory as far as testing performed in one country will be accepted within the Union. The EAEC expects this agreement to come into force on 1 January 2016, and after this date, current (local) registration certificates will be valid until their expiry dates or, if there is no expiry date, until 31 December 2021.
    The draft of the regulations implies a common approach on vigilant data collecting and reporting (a reporting period of five days was set) and labelling (special symbols will be required) for medical devices approved for the EAU.
  2. Coming Regulations on State Procurements of Medical Devices in Russia: “Constraints” Replaced “Strict ban”.
    After the negative feedback from medical and business associations on the draft of the Resolution on “On establishing a ban on individual types of medical devices originating from foreign countries for State and Municipal procurements”, the Russian Ministry of Industry and Trade (Minpromtorg) has officially announced the revision of its position. The term “strict ban” for state procurements for certain groups of medical devices has been replaced with the term “constraints”. The new version of the document assumes that foreign manufacturers will be able to participate in public procurement in the case when fewer than two bids from EAU manufacturers have been submitted for tender. These limitations do not extend to all medical devices, but only to a certain list of products, which has also undergone some changes: some X-ray equipment have been excluded from the list, meanwhile ECG, refrigeration equipment, diagnostic test kits and reagents have been added. It was also highlighted that conformity to the ISO 13485-2011 standard is necessary for EAU manufacturers in order to participate in state and municipal procurements.
  3. New Edition of the Registration Rules in Russia:
    New amendments to the registration rules (Resolution 1416) came into force on 29 July. The most positive outcome is the possibility to eliminate faults during experize phase. Previously there was no such option and any discrepancy in the dossier revealed by the regulator during expertise usually led to an official refusal of registration. On the other hand, some important and broadly-discussed suggestions for improvement, such as fast-track approval for first class medical devices and special procedures to renew expiring registration certificates, have NOT been approved. The new edition of the registration rules slightly extends timelines and reasons for renewals and requires the provision of clinical data in the registration dosser (not before clinical trials as it was previously).

 

Kazakhstan has introduced a system of accelerated registration of medical equipment

Posted on by
Reply

System accelerated registration of medical equipment introduced in order to improve their state registration procedures, as well as access to health care organizations innovative medical technology. Now, medical equipment, which is certified international expert organizations that have concluded an agreement with the competent authority in the field of health, will rapidly be registered within 5 working days. Earlier this period was 120 days. In the city of Munich (Germany) signed a Memorandum of Understanding between the Ministry of Health and by TUV SUD Product Service GmbH, which provides European quality certificate, which is mandatory for the admission of goods into the European market. The Agreement provides for bilateral cooperation in the field of medical technology through the exchange of experience in assessing the quality of production of medical devices, information in the registration of medical technology and express check in Kazakhstan medical technology with a certificate of TUV SUD Product Service GmbH. With this amendment the Kazakhstan market opens for the world’s top manufacturers of medical equipment.
Source: http://www.mz.gov.kz