Completing trials is required to have the medical product listed in the State register and to obtain a registration certificate. The list of requirements for various types of trials, as well as the respective procedures are stipulated by the Order of the Russian Ministry of Healthcare No. 2n dated 9 January, 2014.
All medical products undergo technical trials at design stage. Supporting documents should be included in the registration file. Depending on the product type and class, the following types of technical trials are distinguished:
- technical trials — check of the product’s technical features and parameters, of the compliance with current standards, analysis of manufacturing conditions, etc.;
- toxicity tests — required only for human contact products, sanitary, chemical and biological features of the product are assessed;
- pattern evaluation of measuring instruments, required for medical devices equipped with sensors, counters, thermometers, etc.
Clinical trials are the final step before the last stage of the quality, efficiency and safety tests of the products. State registration procedure is suspended for the duration of the clinical trials. Following the consideration of the documents confirming the completion of the clinical trials, a decision is made to issue a state registration certificate or to refuse state registration of the medical product.
Class 1 hazard medical products are entitled to simplified state registration and clinical trials procedures. The results are documented and submitted together with the registration file.
Our experts have extensive experience of collaboration with accredited laboratories and clinics listed in the State register. That is why we guarantee to provide duly and promptly the following services:
- draw all required documents and assure follow-up of the technical trials of medical products;
- draw all documents related to the clinical trials;
- promptly provide all necessary explanations and consultations on the issues arising in the course of trials.
Our experience has proved that high quality document preparation and follow-up of the technical and clinical trials is a key to successful registration of medical products.
We provide follow-up for all technical and clinical trials in the name of the client, thus assuring high quality of all documents drawn in accordance with the Roszdravnadzor requirements.