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

October 2014 was remarkable with a series of “big events” on the Russian regulatory landscape which opened up possibilities to get first-hand information from Russian regulatory bodies: a public seminar by Roszdravnadzor on clinical trials, a big conference “Farmmedobrashenie” and a public discussion on “Federal Act on Medical Devices”.

The first interesting statistics on registration of medical devices for this year appeared: the Head of Medical Device registration department announced that there were 1176 positive and 428 negative expertises for registration of medical devices in 2014. It was also stated that after new amendments to registration rules came into force in July, the number of positive outcomes has been rising rapidly, more than tripling, and the quantity of negative outcomes for last two months consisted of 7%.

But…here are the three most important news items I would like to highlight:

  1. Eurasian Economic Union – ratification is completed.
    The Treaty on the Eurasian Economic Union signed by Russia, Kazakhstan and Belarus on 29th May 2014 was ratified by all countries of the Union. Russia officially ratified the document on the 3rd of October, Belarus on the 9th of October and Kazakhstan on the 14th of October. It should be reiterated that the document will come into force on the 1st January 2015 and defines, amongst others, common rules for circulation and registration of medical devices and one registration certificate valid throughout the whole EAU territory from January 2016.  Current “local” registration certificates will be valid within a transition period until 31st December 2021 and will require re-registration according to the new EAU procedure before this deadline.
  1. First edition of the list of implantable medical devices is expected on the 18th of November.
    Strict deadlines (the 6th of October) to submit the dossier for official lists “subject to state reimbursement programmes for implantable medical devices” caused a bustle in the medical device industry at the beginning of the month. Over several days 829 dossiers have been submitted from 72 applicants including manufacturers, distributors, clinical centres and professional associations. The Russian MoH promised to publish the first version of the list after the first Commission session on the 18th of November and also confirmed deadlines for submission for next year`s edition of the list as March 2015.
  1. Federal Law on Medical Devices – the text is available for discussion.
    The text of the draft of the Federal Law on Circulation on Medical Devices became available and became the subject of discussion and critiques on different levels. The current version of the draft describes the powers of federal bodies and stipulates the regulation of medical devices’ circulation throughout their entire life cycle including importation, registration, advertisement, distribution, safety monitoring etc. The draft is available in Russian here.

Ten Questions about Clinical Trials of Medical Devices in Russia

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.