“A complex landscape, which is continuing to be adjusted” …this quote, by the head of the medical device expertise body, is a description of what is going on today in the regulation of medical devices in Russia and was the main idea behind the seminar on the registration of medical devices in Russia, held by the medical device regulator on the 6th and 7th of April in Saint-Petersburg. In addition to the official reports of experts, a lot of time at this event was assigned to live discussion, with representatives of Russian and international medical device companies. I would like to highlight below the most interesting of these questions which were answered by the experts:
- Question: Is it allowed to group in one registration submission several medical devices of different types according to the Russian nomenclature classification?
Expert answered: No. It is possible to group medical devices only within one type of nomenclature classifier. This question is still open for renewals of registrations already granted, and Roszdravnadzor (the Russian medical device regulator) is considering the possibility of listing multiple types of medical devices in the registration certificates issued previously.
- Question: What should I do if the type (code) of my medical device is not listed in the nomenclature classifier?
Expert answered: Roszdravnadzor is working to keep the national medical device nomenclature classifier updated and harmonized with global medical device nomenclature (GMDN). If the type (code) of a medical device is not listed in the current version of the classifier, it is recommended to submit the code GMDN for the medical device in the technical file. In this case, the regulator will assign a similar Russian code.
- Question: Can I get a formal consultation on the registration process with Roszdravnadzor or an expert organization?
Expert answered: Currently, Roszdravnadzor does not consult applicants. Any question about the registration of medical devices is only possible in the form of a written request. It should be noted however, that Roszdravnadzor is currently considering legal mechanisms for the possibility of such consultations in the future.
Expert organizations also do not provide consultation options for applicants, and they conduct their activities only upon request of Roszdravnadzor. According to the Decree of Ministry of Health number 1353N, direct communication between experts and applicants is prohibited. If the applicant has any query for the expert organization, it should apply to Roszdravnadzor.
- Question: Who and how determines if a borderline product (e.g. medical device, pharmaceuticals, biological product) can be registered as a medical device?
Expert answered: Before the registration of borderline products, this question should be addressed (with a technical file and IFU) to the special interdepartmental commission convened regularly by Roszdravnadzor.
- Question: Is Russian registration mandatory for a medical device manufactured in Russia for export sales only?
Expert answered: Yes. Manufacturing is part of the life-cycle of a medical device; therefore, registration is mandatory in order to start production of any medical device in Russia, even if it is for export purposes only.
- Who and at what stage of the registration process defines whether a medical device will undergo full clinical trials, or only evaluation of clinical data for the registration?
Expert answered: After the first stage of the expertise and obtaining the authorization of Roszdravnadzor, the clinical investigation plan, including study design, should be developed by the applicant together with an accredited clinical center. It is an obligation for the applicant to provide an appropriate evidence base in order for the clinical center to make a decision about how clinical data could be obtained.
- Are there any requirements for the design plan of the clinical trial?
Expert answered: A program of clinical trials can be drafted in any form and should contain the information required by ISO 14155-2008
- Question: How can I perform clinical trials of an analyzer and in-vitro reagents, if these items should be submitted for registration separately?
Expert answered: Such items should undergo clinical trials and technical testing together. The same rule applies to analytical systems, components of which are registered as individual medical devices (glucometers, test strips, test solutions).
- Is clinical usage of a medical device authorized when the registration certificate has expired?Expert answered:
Yes. According to the explanation of the Ministry of Health, if a medical device was imported into Russia, and purchased by a clinical center during the period of validity of the registration certificate, then such a medical device can be used for clinical purposes until the end of lifetime indicated in the IFU.
Disclaimer: the objective of this post is solely to provide information about the seminar that I found interesting from my professional point of view. This post is NIETHER an official report NOR recommendation and does NOT state official position of any organization or regulatory body.