Circulation of medical devices in Russian Federation market is possible only after their registration in Federal Service on Surveillance in Healthcare (Roszdravnadzor).
The order of registration of medical devices fundamentally changed in 2012, when the Government Resolution ¹ 1416 of 27.12.2012ã., setting the new procedure of medical devices registration, was issued.
Two expert organizations are defined, which are authorized to conduct expertise of the documents presented by the applicant:
- All-Union Scientific Research and Test Institute (VNIIMT) of Roszdravnadzor.
- Centre of Monitoring and Clinical and Economic Expertise (CMIKEE) of Roszdravnadzor.
The registration procedure consists of two stages. The first stage is technical expertise, it includes the estimation of technical and service documents for the medical device and also the protocols of technical and toxicological tests of the medical device samples, conducted by testing laboratories accredited by RosAccreditation and Roszdravnadzor. Upon the results of the first stages, the experts make the Conclusion affirming technical and biological safety of the medical device and give the permission for conducting clinical trials. Otherwise, the registration of the medical device is refused.
After the permission for clinical trials is received, the applicant conducts the clinical trials in medical institutions accredited by Roszdravnadzor. The clinical trials are conducted in two forms: in form of estimating the data about clinical use of the medical device, and in form of clinical trials on humans, in accordance with regulatory documents setting the procedure of conducting clinical trials on voluntary patients. The protocols of clinical trials are submitted to Roszdravnadzor for the second stage of the expertise in the expert organization. In case of the positive conclusion the Registration Certificate for the medical device is issued (permanent), otherwise the registration is refused.
The expert organizations and Roszdravnadzor make high demands to technical and service documentation presented for the expertise. The experts estimate the completeness of technical and toxicological testing of samples for Russian Federation standards (GOST R) and for verifying the technical data, stated in technical and service documentation for the medical device.
LLC “Resultat-Audit” completely organizes the whole process of preparing the technical and service documentation according to Roszdravnadzor demands, works out the programs of technical and toxicological tests, conducts the tests in laboratories and prepares the complete dossier for submitting to Roszdravnadzor. Upon receiving the permission for clinical trials of the medical device, “Resultat-Audit” together with the applicant prepares the documents about clinical use of the medical device and organizes the clinical trials in accredited medical institutions, and then - forms the dossier upon results of clinical trials and submits it to Roszdravnadzor for the second stage of the expertise.
LLC “Resultat-Audit” has a long experience of organizing the process of medical devices registration in Roszdravnadzor. Our partners are:
ABG Lab LLC (USA), Maquet Critical Care AB (Sweden), Boston Scientific Corp. (USA), Medizintechnik Sattler GmbH (Germany), CareFusion UK 232 Ltd (Great Britain), Guangdong Biolight Meditech Co., Ltd. (China), Natus Medical Inc (USA), BIOTRONIK SÅ & Cî. KG (Germany), SIA Biosan (Latvia), Medonica Co., Ltd. (Corea), MELAG Medizintechnik oHG (Germany), Ameco Medical Industries (Egypt), Bayer Medical Care Inc (USA), Scientech Corp. S.r.l. (Italy), Sterimedix Limited (Great Britain), PROMA REHA, s.r.o (Czech Republic), MAR COR PURIFICATION, INC (USA), Shandong Yuda Medical Equipment Co., Ltd (China), Shandong Yuda Medical Equipment Co., Ltd. (China), B.J.Z.H.F Panther Medical Equipment Co. Ltd (China), XCELENS SA (Switzerland), World Electronic (Shenzhen) Co. Ltd (China) and others.
LLC “Resultat-Audit” has also long-term partnership with Russian producers of medical equipment. Our specialists together with technical experts of testing laboratory “Electrontest” (electron-test.ru) conduct the expertise of construction and service documentation for Russian medical devices, organize the acceptance tests and prepare the dossier of documents for the expertise in Roszdravnadzor.