A medical device for in vitro diagnostics is any medical device intended by the manufacturer to study samples of human biological material without contact with a patient in separate application or in combination with other medical devices, only for the purpose of obtaining regarding physiological or pathological condition, and (or) fetal development problems, and (or) monitoring therapeutic interventions, and (or) determining tissue compatibility. This device may include containers for collecting and storing samples, software and related tools, devices or other items used for diagnostic purposes or to aid in diagnosis. [1]

The registration procedure for medical devices for in vitro diagnostics is carried out in accordance with Decree No. 1416 of 27 December 2012 “On Approving the Rules for State Registration of Medical Devices”. This is the main document establishing the state registration procedure. Let us consider in details the registration procedure for medical devices for in vitro diagnostics.

An expertise of the quality, efficiency, and safety of a medical device for in vitro diagnostics is carried out by an expert institution within one stage, for the registration of the devices for in vitro diagnostics it is necessary to provide a set of documents, of which the main ones include a statement for the state registration of a medical device, as well as a complete report of technical and clinical studies and, if necessary, test results in order to approve the type of measuring instruments.  In addition, it should be noted that toxicological studies may not be applicable to the devices for in vitro diagnostic, but only if these are intended for qualified medical personnel [2, 3].

The verification procedure for the registration dossier takes 5 working days, the registration authority examines the completeness and accuracy of the information contained therein. In the event of the improper wording of documents, lack or nonconformity thereof, the registration authority allows for the elimination of the same within 30 calendar days.

After eliminating the identified comments, a full examination of the study results is carried out and the registration authority sends the complete set of documents to the expert center, which should examine the material submitted and draw up a conclusion within 10 working days.  Within one working day after a decision about the state registration of a medical device is made, the registration authority shall enter the data on the registered medical device in the state register.

If the expert center does not consider the materials provided to be sufficient, then within 2 working days of receipt of the request, the expert center shall send to the applicant a request for the necessary information specifying the nature of the comments and relevant remedies. The deadline for eliminating the comment is 50 working days.  After all comments have been resolved, the expert center examines the materials and new amendments within 10 working days and, upon a positive decision, provides its conclusion. After the registration authority receives this conclusion, it enters the data about the registered medical device in the state register within one working day [3].

In general, the registration procedure for medical devices for in vitro diagnostics can be considered more expeditious compared to the registration of medical devices not for in vitro diagnostics, since the registration of such devices takes place in two stages of examination. However, the preparation of a report on clinical studies of the medical devices for in vitro diagnostics takes a long time, due to the fact that clinical laboratory tests are applied using samples of patient biomaterial.

References:

1. GOST R 51088-2013 Medical devices for in vitro diagnostics. Reagents, reagent kits, test systems, control materials, culture media. Device requirements and supporting documentation.
2. Order N 2n dated 9 January 2014 “On approval of the procedure for conformity assessment of medical devices in the form of technical tests, toxicological studies, and clinical trials for the state registration of medical devices”
3. Decree No. 1416 dated 27 December 2012 “On Approval of the Rules for the State Registration of Medical Devices”.